Associate Director, Senior Clinical Scientist

Position Summary

The Senior Clinical Scientist reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs.

• Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials.
• Responsible for planning and leading the Local Health authority/ Subject Expert Committee interactions for assigned projects
• Successfully leads, plans, and executes trial-level activities for multiple trials with minimal to moderate level of supervision.
• Provides scientific and clinical leadership to the team of supporting Clinical Scientists (matrix leadership)
• Co-leads study team meetings in partnership with the GDO protocol manager; and collaborates with cross-functional study team members.
• May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)

Duties/Responsibilities

• Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members.
• Plan and Lead interactions with local health authorities including presentation to Subject Expert Committees
• Plan and lead the implementation of all study startup/conduct/close-out activities as applicable.
• Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)
• Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross-functional comments, and ensuring high clinical quality (collaboration with Medical Writing)
• Site-facing activities such as training and serving as primary contact for clinical questions
• Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
• Clinical data trend identification: provide trends and escalate questions to the Medical Monitor
• Develop a clinical narrative plan; review clinical narratives.
• Provision of information required by the Protocol Manager for the development of the trial budget, CRO scope of work, etc.
• Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
• Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
• Collaborate and serve as the primary liaison between external partners for scientific advice

Qualifications and Experience:

• Medical qualification (MD in Pharmacology, Oncology or Hematology is preferred)
• 10+ years of experience in clinical science, clinical research, or equivalent
• Excellent track record of leading scientific interactions with DCGI and Subject Expert Committees
• Experience in Oncology and Hematology therapeutic areas is preferred
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
• Proficient knowledge and skills to support program-specific data review, trend identification, and data interpretation.
• Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
• Excellent verbal, written, communication, and interpersonal skills.
• Detail-oriented.
• Strong sense of teamwork; ability to lead team activities.
• Proficient knowledge of the disease area(s), KOLs, indication(s), and compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
• Proficient critical thinking, problem-solving, and decision-making skills.
• Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism.
• Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)
• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review, or similar data reporting tools
• Domestic and International travel may be required.