260 Clinical Development Jobs - Page 2

Learning Development Coordinator ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Learning Development Coordinator to join our diverse and dynamic team. As a Learning Development Coordinator at ICON, you will play a key role in driving the delivery and coordination of learning and development programs across the organization and for our clients. You will ensure smooth execution of training initiatives, helping to foster a culture of growth and continuous learning for all employees. What You Will Be Doing: Coordinating and scheduling training sessions, workshops, and other learning events. Aiding the development and delivery of learning materials and active resources. Tracking and reporting on participation and completion rates for training programs. Collaborating with internal teams to ensure seamless execution of learning initiatives. Managing learning management system (LMS) updates and troubleshooting user issues in both client-specific and ICON training systems. Your Profile: Bachelor s degree in Human Resources, Education, or a related field. Previous experience in a learning and development or administrative role. Strong organizational and project coordination skills, with the ability to manage multiple tasks. Excellent communication skills and attention to detail. Proficiency in Cornerstone learning management systems (LMS) and Microsoft Office Suite. At least 12 months or more experience as a administrator in Cornerstone learning management system. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. ReadyAs a Biostatistician Technical Expert - Clinical Statistics within our Clinical Statistics Team at Hyderabad , you ll lead/oversee statistical support of a team of senior and principal biostatisticians, be accountable for statistical aspects and deliverables of the team for several early/late phase studies. Provide directions and guidance in carrying out project assignments, interacting with other internal functions and applying advanced statistical methods while ensuring scientific integrity to project work. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people s lives. We re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started Main responsibilities: Support the clinical development plan (CDP), clinical study design (including protocol development and review), the study setup and conduct. Conduct / Oversee the execution of the statistical analyses according to the SAP and ISAP, prepare statistical methods provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs. Serve as a biostatistical consultant for other members of the department and staff members from other statistics department within the organization. Provide mentoring and coaching advanced statistical methodologies to junior statisticians in Hub. Maintain knowledge and awareness of development in biostatistics and clinical trial methodology and regulatory requirements that impact on analysis. Accountable for all assigned statistical deliverables related to multiple studies or specific domains: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, Estimands etc., SAP, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables). Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives. Contribute to define and review the specific deliverables related to Transparency and Disclosure. Coordinate with study programmer the production and Qc of statistical analyses. Contribute to operation process optimization and provide inputs to statistics and quality standards. Represent statistics team to participate in scientific or technology working groups or cross function initiatives. About you Experience : 7+ years (MS) or 5+ years (PhD) of solid pharmaceutical industry experiences. Experience of project management and development preferred. Soft and technical skills : Broad knowledge and good understanding of advanced statistical concepts and techniques Demonstrated strong project/study management, interpersonal and communication skills. Good knowledge of pharmaceutical clinical development, together with early, late phase and post-marketing experiences Extensive ability to apply advanced statistical analyses using SAS and R languages. Knowledge or experience with Artificial intelligence or Generative AI is a plus Education : MS or PhD degree in Statistics or relevant fields Languages : Highly effective communication in English, both oral and written. Why choose us Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave. Build, develop and manage a statistics team support multiple TAs and different clinical phases Develop a career of being an influential statistician Gain international clinical trial experiences and communicate with Health Authorities worldwide

Learning & Development Coordinator We are currently seeking a Learning & Development Coordinator to join our diverse and dynamic team. As a Learning & Development Coordinator at ICON, you will play a key role in driving the delivery and coordination of learning and development programs across the organization and for our clients. You will ensure smooth execution of training initiatives, helping to foster a culture of growth and continuous learning for all employees. What You Will Be Doing: Coordinating and scheduling training sessions, workshops, and other learning events. Aiding the development and delivery of learning materials and active resources. Tracking and reporting on participation and completion rates for training programs. Collaborating with internal teams to ensure seamless execution of learning initiatives. Managing learning management system (LMS) updates and troubleshooting user issues in both client-specific and ICON training systems. Your Profile: Bachelor s degree in Human Resources, Education, or a related field. Previous experience in a learning and development or administrative role. Strong organizational and project coordination skills, with the ability to manage multiple tasks. Excellent communication skills and attention to detail. Proficiency in Cornerstone learning management systems (LMS) and Microsoft Office Suite. At least 12 months or more experience as a administrator in Cornerstone learning management system. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Novo Nordisk Global Business Services (GBS) India Department- Clinical Drug Development (CDD) - Bangalore Global Development Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen we might have the right position as Statistical Monitor for you. Apply now and join a growing team, working in an international environment. About the department Clinical Data Science, Global Business Services (CDS GBS) was started in September 2007 and within a short span of 16 years since its inception, has transitioned from a small start-up to one of the largest units in GBS and a key contributor to Novo Nordisk clinical development portfolio. As the organisation is growing along with the Research & Development portfolio, we are looking for several new medical Reviewing colleagues. In Clinical Data Science, we are responsible for managing clinical drug development worldwide from early development phases to product introduction. The CMU Bangalore is established in GBS to support the Risk Based Monitoring of clinical trials conducted by Novo Nordisk in line with health authority requirements. The unit is responsible for performance of centralised medical review of patient data that includes medical monitoring and lab surveillance; Statistical Monitoring analysis, and generation of visualisations and reports identifying outliers and trends from various data sources. The Position The Statistical Monitor plays a critical role in supporting Risk-Based Monitoring within Clinical Drug Development by operating and maintaining the centralized Statistical Monitoring function. This position focuses on detecting unusual data patterns, systematic errors, and potential instances of non-compliance or fraud that may not be identified through routine monitoring processes. The Statistical Monitor analyses clinical data across trials and projects to safeguard data integrity, which is essential for the approval of new drug. The role requires a high level of independence, with the potential to mentor junior colleagues and contribute to continuous improvement in data reliability and compliance. Responsible to operate and maintain the Statistical Monitoring function to identify unusual data patterns, systematic errors, and potential protocol non-compliance or fraud across clinical trials and projects. Work closely with trial and project teams, as well as data management and programming experts, to plan and execute statistical monitoring activities according to project timelines. Communicate monitoring observations to relevant stakeholders, support the interpretation of data issues, and contribute to data correction and quality improvement efforts. Contribute to the development, maintenance, and enhancement of statistical monitoring tools and methodologies, including exploring and implementing new techniques. Support training initiatives, participate in meetings and seminars, and foster strong collaboration and knowledge sharing with colleagues and cross-functional teams. Qualifications Holds university degree in life science or engineering (e.g. B.Sc., MSc, MD) or equivalent. 2 years of experience in pharmaceutical industry and preferably 1 year of experience with exploration and/ or visualisation of clinical trial data and scientific data. Experience from clinical development and understanding of data flow. Thorough understanding of clinical research and GCP. Understanding of basic statistical methods, preferably experience from reporting/publishing clinical/scientific data. Good knowledge on computer systems and IT. Exposure with SAS / JMP programming. Worked according to GxP and guidelines within drug development.

Medical Writer II (QC of Regulatory Docs) Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives we re able to create a place where everyone feels like they belong. Job Responsibilities Job Description Experience in QC of regulatory MW documents (protocols including amendments, CSRs, IBs and updates, etc). Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with minimal or moderate supervision. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads document reviews, reviews documents as needed, and resolves comments from client. Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content,and for grammar, format, and consistency. Provides feedback to further define statistical output required. Interacts and builds good working relations with clients, department head, and peers, as necessary, to produce writing deliverables. Performs online clinical literature searches and complies with copyright requirements. Identifies and proposes solutions to resolve document issues, escalating as appropriate. Mentors less experienced medical writers on projects, as necessary. Maintains a strong working knowledge of drug development process, regulatory guidelines,industry standards, and best practices. Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership. Completes required administrative tasks within the specified timeframes. Performs other work-related duties as assigned. What were looking for: Bachelor s degree in a relevant discipline with relevant writing experience; graduate degree preferred. At least 2 years of relevant experience in science, technical, or medical writing. Experience working in the biopharmaceutical, device, or contract research organization industry preferred. Familiar with FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly preferred. Experience writing relevant document types preferred. Extensive knowledge of English grammar and ability to communicate clearly; familiar with AMA Manual of Style.

Medical Writer II (Narrative Writing) Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives we re able to create a place where everyone feels like they belong. Job Responsibilities Main experience in CSR safety narratives writing (authoring, addressing review comments, collaborating with teams) Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with minimal or moderate supervision. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads document reviews, reviews documents as needed, and resolves comments from client. Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content,and for grammar, format, and consistency. Provides feedback to further define statistical output required. Interacts and builds good working relations with clients, department head, and peers, as necessary, to produce writing deliverables. Performs online clinical literature searches and complies with copyright requirements. Identifies and proposes solutions to resolve document issues, escalating as appropriate. Mentors less experienced medical writers on projects, as necessary. Maintains a strong working knowledge of drug development process, regulatory guidelines,industry standards, and best practices. Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership. Completes required administrative tasks within the specified timeframes. Performs other work-related duties as assigned. What were looking for: Bachelor s degree in a relevant discipline with relevant writing experience; graduate degree preferred. At least 2 years of relevant experience in science, technical, or medical writing. Experience working in the biopharmaceutical, device, or contract research organization industry preferred. Familiar with FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly preferred. Experience writing relevant document types preferred. Extensive knowledge of English grammar and ability to communicate clearly; familiar with AMA Manual of Style.

The position of Medical Writer II (Narrative Writing) at Syneos Health involves compiling, writing, editing, and coordinating medical writing deliverables that clearly and accurately present scientific information. Working within and across departments with minimal or moderate supervision, the Medical Writer completes various documents such as clinical study protocols, patient narratives, investigator brochures, informed consents, journal manuscripts, and presentations for scientific meetings. Adherence to established regulatory standards, including ICH E3 guidelines, company SOPs, and client standards is crucial to ensure timely and budgeted completion of medical writing projects. Key responsibilities of the role include coordinating quality and editorial reviews, managing source documentation, acting as a peer reviewer for internal teams, reviewing statistical analysis plans, and interacting with clients and peers to produce high-quality writing deliverables. The Medical Writer mentors less experienced writers, maintains a strong knowledge of drug development processes and regulatory guidelines, and performs online clinical literature searches while complying with copyright requirements. The ideal candidate for this role should hold a Bachelor's degree in a relevant discipline with at least 2 years of experience in science, technical, or medical writing. A graduate degree is preferred, and experience in the biopharmaceutical, device, or contract research organization industry is advantageous. Familiarity with FDA and ICH regulations, good publication practices, and extensive knowledge of English grammar are essential. Additionally, the candidate should be well-versed in the AMA Manual of Style. Syneos Health is committed to developing its employees through career progression, supportive management, training programs, peer recognition, and a total rewards program. The company fosters a Total Self culture that values authenticity and diversity of thoughts, backgrounds, and perspectives to create an inclusive work environment where everyone feels they belong. By joining Syneos Health, employees have the opportunity to work in a collaborative and innovative setting dedicated to accelerating the delivery of therapies and changing lives. For more information about Syneos Health and its impact in the healthcare industry, please visit http://www.syneoshealth.com. Please note that the tasks, duties, and responsibilities outlined in this job description are not exhaustive, and the company reserves the right to assign additional responsibilities at its discretion. Equivalent experience, skills, and education will also be considered in evaluating candidates for the position. The language used in this description complies with all obligations imposed by relevant legislation, including the Americans with Disabilities Act.,

As an Associate Director, Statistical Programming at Syneos Health, you will be part of a leading biopharmaceutical solutions organization focused on accelerating customer success. Our company is dedicated to translating clinical, medical affairs, and commercial insights into tangible outcomes that address the modern market landscape. In our Clinical Development model, we prioritize putting the customer and patient at the core of our operations. We are committed to simplifying and streamlining our processes to enhance collaboration and make Syneos Health a preferred partner. Whether you are engaged in a Functional Service Provider partnership or a Full-Service environment, you will work alongside passionate problem solvers, fostering innovation and teamwork to help our clients achieve their objectives. Our agile and driven approach aims to expedite the delivery of therapies, driven by a shared passion to make a positive impact on people's lives. At Syneos Health, we value the development of our employees through various avenues such as career growth opportunities, supportive management, technical and therapeutic training, peer recognition, and a comprehensive rewards program. Our Total Self culture encourages authenticity and inclusivity, fostering a global environment where individuals can truly be themselves. By embracing diversity of thoughts, backgrounds, cultures, and perspectives, we create a workplace where everyone feels a sense of belonging. Syneos Health has a rich history of collaborating on groundbreaking projects, having contributed to 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies involving 73,000 Sites and 675,000+ Trial patients in the past 5 years. Regardless of your role within the organization, you will be encouraged to take initiative, challenge conventions, and thrive in a dynamic and competitive industry environment. Please refer to the detailed job responsibilities that will be discussed during the Discovery call to gain a deeper understanding of the expectations associated with the role of Associate Director, Statistical Programming at Syneos Health. Kindly visit our website http://www.syneoshealth.com to learn more about our company and the impactful work we do globally. Please note that the tasks, duties, and responsibilities outlined in this job description are not exhaustive. The Company reserves the right to assign additional tasks and responsibilities as needed. Equivalent experiences, skills, and education will also be considered, potentially resulting in differences between the qualifications of individuals and those mentioned in the Job Description. The Company will determine equivalencies at its discretion. It is important to understand that this document does not establish an employment contract. We are committed to compliance with the Americans with Disabilities Act and strive to provide reasonable accommodations when necessary to support employees or applicants in performing their job functions effectively.,

Job Title: Medical Data Abstractor (MDA) Department: Delivery Job Location: Turbhe, Navi Mumbai (Work from Office) Reporting To: Lead Job Duties / Responsibilities: Data management and Curation Performs complex data abstraction (i.e. requiring interpretation) and data entry for specified disease and project requirements. Participates and contributes to team meetings and learning sessions. Maintains a high level of medical knowledge and terminology and expertise of electronic medical record and data capture systems. Self-reports activities like time spent on records, audits completed including all relevant details and any other reporting functions assigned by Operations and QA management teams. Quality Assurance Consistently complies with minimum quality levels indicated in the QA plan for each project (>95% or higher accuracy depending on the project). Receives feedback from Quality Analyst and ensures timely reconciliation of errors. Participates in quarterly Inter rater reliability (IRR). Special Projects May lead or participate in special projects or client-specific initiatives as directed. Education and Experience: Graduate / PG - Medicos: BDS, MDS, BAMS, BUMS, BHMS, BPT, MD. 0-5 years of experience in the clinical or non-clinical field. Should be presentable and pleasant. Ability to multitask, work under pressure, and meet deadlines required.,

Investigator Payment Associate - India, Chennai - Hybrid, Office-Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are now hiring Investigator Payment Associate in Chennai location and looking for highly dynamic and professionally sound aspirants like you. The role: To support the Investigator Payments team with set up and maintenance of ICON s investigators payments as appropriate. To support team lead and be the main point of contact for issue customer concern in the absence of a more senior member of IPG team To positively chip in to the IP group by seeking to continuously improve their job performance and knowledge of IPG systems and processes To support Clinical staff in executing accurate, timely and efficient investigator payments in accordance with investigator contract Clients Delivery to Customers, Building Relationships Communicate effectively with investigative site personnel and/or ICON or Sponsor Clinical Project Managers, regarding payment inquiries and handling their expectations accordingly. Liaise with all other ICON departments such as Clinical, PTS, IT, Finance, legal and contracts to ensure payment queries are speedily resolved. To effectively build and maintain a productive working relationship with the Clinical teams and other ancillary department staff to effectively handle their needs and expectations in relation to payments. You will need: Minimum of 2 years relevant work experience preferred, or has proven aptitude necessary to execute this role. Ability to liaise successfully with all levels of management at ICON, vendors, and clients. Good working knowledge of PC applications (Excel, Word, Outlook and Access). Excellent organizational, administration and problem solving skills. Excellent written and verbal communication skills. Excellent Customer Relationship Management skills. Ability to easily adapt to dynamic environment working to strict deadlines and targets. Good numerical ability an advantage. Bachelor s degree or local equivalent in a related field. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles.

Payroll Associate - India, Chennai ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development The Role: Ensuring payroll inputs to third party payroll vendors are finalized accurately. Working cross functionally, you will act as a liaison with external payroll providers and internal departments, such as HR and Finance Ensure internal controls are applied so that monthly changes are captured and processed accurately and that any discrepancies recorded and discussed. Upload electronic files and input any manual payments to the bank You will handle the Payroll mailbox to ensure queries are responded to in a timely fashion. Making sure that all monthly and annual tax, pension and compliance requirements are followed. Collaborating with internal and external auditors to provide timely reports as required. Work as part of Payroll team to ensure that all processes are as efficient as possible, detailed appropriately and SOX Compliant. You will have the opportunity to get involved in special projects throughout the year. You will need Experience of APAC/EMEA Payroll processes and working with payroll vendors (preferable but not essential) Proven experience of working in a dynamic environment. Excellent verbal, written and interpersonal skills with an emphasis on customer service. Ability to work to strict deadlines with a high volume of transactions. Attention to detail with excellent numerical and analytical skills. Great teammate. Proficient user of the Microsoft Office Suite, particularly Excel. Positive and dedicated approach to work, able to work on own initiative Good organization skills disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Interested in the role, but unsure if you meet all of the requirementsWe would encourage you to apply regardless there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON EmployeePlease click here to apply

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products that cater to the needs of underserved patients. With a focus on providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products cover various therapeutic areas such as cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, benefiting millions of patients worldwide. For more information about Azurity, please visit www.azurity.com. Azurity Pharmaceuticals is committed to fostering an inclusive workplace and is proud to be an Equal Opportunity Employer. The company attributes its success to its talented and dedicated team that prioritizes improving patients" lives by incorporating the best science and commitment to quality in all aspects of its work. Azurity seeks individuals who are highly motivated, possess integrity, dedication, and a creative spirit to excel within the organization. As a part of the Clinical Development team at Azurity, the Manager, Clinical Development plays a vital role in supporting early development activities across multiple therapeutic areas. Reporting to the Director, Clinical Development, the candidate will collaborate with stakeholders and team members to ensure scientific excellence, build effective relationships across Research & Development, and optimize the design and analysis of clinical investigations. **Principle Responsibilities:** - Design studies with a focus on technical, regulatory, and formulation aspects. - Collaborate with program managers and study teams to develop study plans aligned with the overall development plan and key milestones. - Ensure compliance with GCP, local and target regulatory guidelines, study protocols, and identify and address areas of concern. - Oversee study operations, including initiation, monitoring, and closeout, sample shipment, and communication with CROs, involving travel to CRO locations and study sites. - Independently perform non-compartmental PK analysis, PK modeling, and IVIVC communication of trial status and data to cross-functional teams. - Manage data repository, TMF, and critical study documents, proposing alternative strategies to optimize time, cost, and resources. - Contribute to the development, review, and approval of clinical study documents, such as ICF, IB, CRFs, study reports, and regulatory documents. **Qualifications And Education Requirements:** - Master's, Pharm.D, or PhD degree in clinical research, pharmacology, or equivalent field. - Minimum 6 years of pharmaceutical industry experience, with 4-5 years of experience in Phase 1 or 2 clinical development. - Sound understanding of US and ex-US regulatory clinical requirements, drug development continuum, and knowledge of regulatory approval processes. - Familiarity with ICH guidelines, GCP, biostatistics, and pharmacokinetics. - Strong organizational, interpersonal, and communication skills with the ability to work collaboratively in a cross-functional team. - Excellent analytical, problem-solving, and communication skills. By applying for this role, you confirm your ability to fulfill the job responsibilities outlined in the job description without any restrictions. If you have concerns or disabilities that may affect your performance, please inform HR in advance.,

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.