497 Clinical Development Jobs - Page 4

What you will do In this vital role you will lead an Agile product squad and responsible for defining the vision & strategy and implementation for a range of Clinical Data products supporting Amgen Clinical Trial Design & Analytics. You will collaborate closely with statisticians, data scientists, data engineers, and AI/ ML engineers teams to understand business needs, identify system enhancements, and drive system implementation projects. Your extensive experience in business analysis, system design, and project management will enable you to deliver innovative and effective technology products. Roles & Responsibilities : Define and communicate the product feature vision, including both tech...

Role Name: Manager International Regulatory Lead (IRL) Department Name: International Regulatory Team, Global Regulatory Affairs Role GCF: 5A ABOUT THE ROLE Role Description The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to -optimize product development and regulatory approvals in International countries -develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities -Advises Global teams on regulatory impl...

What you will do In this vital role you will Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards Write or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 4) Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety documents, across therapeutic areas and for biosimilars (mandate) Write other regulatory submission documents (eg, RTQs, PIP, white papers, breakthrough therapy...

What you will do Lets do this. Lets change the world.Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership. As a Biostatistics Sr. Manager, you will lead study-level statistical deliverables with substantial independence. This role manages small teams, mentors staff and ensures the delivery of high-quality statistical outputs that meet CfDA and regulatory expectations. Responsibilities: Utilizing knowledge and expertise to inform and provide sound statistical guidance to areas and teams in clinical development, reimbursement, and medical affairs. Plan and execute statistical contributions to protoc...

Role Description : The Content Manager, Scientific Communications, is a key member of the Scientific Communications organization within the Global Medical Organization. This role is accountable for delivering innovative scientific, publications and medical content aligned to their designated Therapeutic Area / product (General Medicine, Inflammation, Oncology, Rare Disease, or Obesity), tailored to specific audiences globally via impactful formats and relevant channels. Reporting to a Sr. Manager, Scientific Communications (Group Lead) in India, this role will work cross-functionally and globally to drive the execution of tactical Scientific Communication plans for US and global regions to d...

Position Overview: As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills to support one or more Phase I-IV clinical trials, with a focus on Oncology. To be successful in this position you will have: At least 5 years of relevant statistical programming experience in a clinical development environment with 3 years of efficacy preferred. BA/BSc or higher degree in Statistics, Mathematics, Computer Science, Life Sciences, or other related scientific subjects. Excellent SAS data manipulation, analysis, and reporting skills. Ability to implement the latest CDISC ADaM standards (production/validation). Strong understanding/experience with ADaM efficacy dataset d...

Position Overview: As a Senior Statistical Programmer, you will perform programming activities for the creation and validation of SDTM domains by implementing CDISC standards and working on pooled studies ADaM datasets for ISS and submission packages with a focus on Oncology. To be successful in this position you will have: At least 5 years of relevant statistical programming experience in a clinical development environment. BA/BSc or higher degree in Statistics, Mathematics, Computer Science, Life Sciences or other related scientific subjects. Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro languag...

Career Category Medical Affairs Job Description Role Description : The Content Manager, Scientific Communications, is a key member of the Scientific Communications organization within the Global Medical Organization. This role is accountable for delivering innovative scientific, publications and medical content aligned to their designated Therapeutic Area / product (General Medicine, Inflammation, Oncology, Rare Disease, or Obesity), tailored to specific audiences globally via impactful formats and relevant channels. Reporting to a Sr. Manager, Scientific Communications (Group Lead) in India, this role will work cross-functionally and globally to drive the execution of tactical Scientific Co...

The GSSS will report to the GSSS Team Leader (India) and interact with the Clinical Supply Chain stakeholders. Main responsibilities include: Common: Clinical Trial & Supply Knowledge Understandingof clinical trial design, protocols, regulatory requirements (GxP) Understandingof clinical endpoints, patient randomization processes, study arms, dosing regimens, cohort management, stratification factors Understandingof investigational product management in clinical trial including kit types, shelf life, IMP production plan, depot management, IMP distribution, IMP reconciliation, returns/destruction. Level 1 responsibilities: Create and manage transfers to depot in IRT, customize them in Sanofi ...

We are currently seeking a Statistical Programmer II to join our diverse and dynamic team. As a Statistical Programmer II at ICON, you will play a vital role in the development, validation, and execution of statistical programs to support clinical trial analysis and reporting. Your expertise will contribute to the accurate interpretation of clinical data, helping to ensure the successful delivery of research projects. What You Will Be Doing: Developing, validating, and maintaining complex statistical programs (SAS, R, or similar) for data manipulation, analysis, and reporting in clinical trials. Collaborating with biostatisticians and cross-functional teams to interpret study requirements an...

As an Expert Content Manager, Scientific Communications at the Scientific Communications organization within the Global Medical Organization, your role is crucial in delivering high-quality innovative scientific, publications, and medical content aligned with the designated Therapeutic Area/product. You will be responsible for tailoring content to specific audiences globally through impactful formats and relevant channels. Reporting to a Sr. Manager in India, you will collaborate cross-functionally and globally to execute tactical Scientific Communication plans for US and global regions to support Medical and overall product strategies. **Roles & Responsibilities:** - Develop and deliver hig...

Role Overview: As an Associate Director Biostatistics at Amgen, you will play a crucial role in expanding the global Biostatistics capabilities, with a key focus on integrated delivery and functional leadership. Your responsibilities will include providing statistical guidance to clinical development, overseeing statistical contributions to protocols and key trial documents, ensuring alignment with scientific rigor and regulatory requirements, collaborating cross-functionally with global teams, contributing to innovative trial designs, and executing biostatistical strategies across the product lifecycle. Your role will also involve providing consultancy and training to colleagues, supporting...

As a Clinical Development Manager at Azurity Pharmaceuticals, you will play a crucial role in supporting departmental activities related to clinical trials and scientific analyses across therapeutic areas. Reporting to the Associate Director, Clinical Development, you will have the opportunity to contribute to the success of the organization by leveraging your expertise and skills. Your responsibilities will include but are not limited to: - Ability to understand integrated data from clinical trials and other sources to provide scientific evaluations and develop risk assessments. - Providing operational and scientific oversight of nonclinical and clinical studies, ensuring compliance with GC...

Career Category Research Job Description HOW MIGHT YOU DEFY IMAGINATION If you feel like you re part of something bigger, it s because you are. At Amgen, our shared mission -to serve patients - drives all that we do. It is key to our becoming one of the world s leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It s time for a career you can be proud of. Join us. Associate Director Biostatistics What you will do Let s do this. Let s change the world. Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role i...

Career Category Research Job Description HOW MIGHT YOU DEFY IMAGINATION If you feel like you re part of something bigger, it s because you are. At Amgen, our shared mission -to serve patients - drives all that we do. It is key to our becoming one of the world s leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It s time for a career you can be proud of. Join us. Biostatistics Sr. Manager What you will do Let s do this. Let s change the world. Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integ...

Career Category Regulatory Job Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world s toughest diseases, and make people s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what s known today. ABOUT THE ROLE Role Description The International Regulatory Lead (IRL) Sr Associate will provide coordination and execution of regulatory deliverables for International countries for one or more Amgen products....

Career Category Research Job Description Senior Manager, Biostatistical Programming HOW MIGHT YOU DEFY IMAGINATION If you feel like you re part of something bigger, it s because you are. At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world s leading biotechnology companies. We are global collaborators who achieve together researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It s time for a career you can be proud of. Join us. Senior Manager, Biostatistical Programming What you will do Let s do this. Let s change the world. Amgen is expanding its Global Statistical Programming...

As a Medical Affairs professional at Immuneel Therapeutics Private Limited, your role is crucial in advancing patient care by engaging in scientific exchange with external medical experts and industry leaders to enhance the scientific value of the products. In this role, you will have the opportunity to manage key internal and external stakeholders, contributing significantly to the organization's success. **Key Responsibilities:** - **Development & Execution of Medical Strategy:** - Create and implement the Medical Affairs Strategy aligned with the overall Business Objectives. - Assist in developing marketing messaging for launch and commercialization. - Collaborate with multidisciplinary t...

Overview Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries. We are the largest Clinical Pharmacology & Pharmacometric organization in the world, which enables us to assure that various career pathways are offered that match the ambition and personal interests of our employees! As one of Certara s divisions, we deliver value by integrating advanced simulation approaches into the most crucial drug development deliverables - to inform internal decision-making and...

Centralized Clinical Trial Manager, Bangalore/Home-based ICON plc is a world-leading healthcare intelligence and clinical research organization Were 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 Centralized Clinical Trial Manager to join our diverse and dynamic team As a Centralized Clinical Trial Manager at ICON, you will play a crucial role in overseeing the centralized monitoring activities of clinical trials, ensuring the smooth coordination of data-driven insights to enhance trial quality and patient safety You will contribute to the advancem...

Assisting in the planning, initiation, and execution of clinical trial activities Conducting site feasibility assessments and participating in site selection processes Coordinating with investigative sites to ensure compliance with study protocols and regulatory requirements Monitoring study progress and data collection activities to ensure quality and accuracy Assisting in the preparation and review of study documentation and reports Your profile Bachelors degree in a relevant field, such as life sciences or healthcare Previous experience in clinical research or a related field preferred Strong organizational and communication skills Ability to work independently and collaboratively in a fa...

TMF Lead India, Chennai Hybrid: Office based ICON plc is a world-leading healthcare intelligence and clinical research organization Were 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, At ICON, its our people that set us apart Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patientslives, Our ?Own Itculture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity We want to be the Cl...

The team members will be responsible & manage project closure activities related to investigator payments by reviewing internal site contracts vs oracle database vs MCTMS Primary Skills Good in Excel, Reporting, Data Reconciliation, Handling payment data, and good communication skills Standard Excel - intermediate to advance [VLOOKUP, sum, if, data validation, conditional formatting, pivot tables, finding duplicate values, concatenate, converting data from text to columns, formatting date and values] Cost entry, reading the invoices, reviewing the contracts.

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you ll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their busines...

About the job As a Principal Biostatistician, youll Lead or support one or several early/late phase studies, under minimum supervision of statistical team leader.We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were 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. Main responsibilities : Support the clinical study design (including protocol development), the study setup and conduct. Conduct the statistical analyses according to the SAP, prepare statistical methods & provide statist...