Sr. Clinical Scientist, Clinical Development

The primary responsibility of the Sr. Clinical Scientist, Clinical Development (CD) is responsible for providing expert clinical advice across all phases (phase II-IV) of clinical research and may consult with the translational study team. In some cases, if instructed by the Chief Scientific Officer), the Sr. Clinical Scientist, Clinical Development (CD) may work on Phase I studies too. This role has the primary responsibility for contributing to CD activities including the design and development of clinical studies, writing various clinical documents such as, but not limited to, clinical study synopsis, clinical study protocol, investigator brochures etc. Additionally, the Sr. Clinical Scientist may be responsible for leading development programs (an Indication Lead), is adept at strategic thinking, and is responsible for the creation and maintenance of the clinical development plan. Moreover, the Sr. Clinical Scientist is the primary point-of-contact for inquires relating to CD strategy, is responsible for overseeing and guiding the ongoing study data reviews, and providing expert input to the multi-functional, matrixed study and program teams. The Sr. Clinical Scientist is accountable for the on-time achievement of study and/or program milestones in alignment with the program team strategic imperatives.

Responsibilities

Lead

• Lead clinical development scientists for the development and execution of clinical trials under the responsible therapeutic indication.
• Review, guide and approve protocols, and amendments, ICFs, and clinical sections of other documents.
• Interact with thought leaders within the respective therapeutic area/indication.
• Track and update CD team on the CD deliverables across all clinical studies/projects.
• Lead identifying, contracting, and engaging subject matter experts/thought leaders in advisory board meetings, consultancy etc.
• Oversee regular maintenance and update of the CD project folders/drives.
  
  

Clinical Study Planning Development, Data and Reports

• Review, guide and finalize study documents such as Protocol Synopses, Protocols, Protocol amendments, Administrative Change letters etc.
• Ensure CD contributions to trial-related documents such as the IBs, ICF, CRFs, CRF Completion Guidelines, Study Execution and Monitoring Plans, Clinical Data Review Plan, Clinical Database specifications, statistical analysis plan, the data management plan, the medical monitoring plan, Clinical Study Report (CSR) etc.
• Ensure regular and ad-hoc data reviews and interpretation; preparation of summaries/documentations of these reviews to Senior Director/Director, clinical development.
• Ensure timely development of program-level documents, including, but not limited to, abstract and manuscripts, presentations, and various other internal and external documents and communications as needed.
  
  

Clinical Operations

• In collaboration with the Development Operations staff, the Sr. Clinical Scientist develops operational strategies for clinical research studies and development programs including, but not limited to, PI selection, CRO selection, budgets, and timelines.
• Ensure CD participation in vendor selection, specification development, and management/oversight, as needed.
• Facilitation of country and site feasibility/selection processes.
• Ensure development of study specific training materials for study team, investigational sites, and vendors.
• Participate and present at Investigator meetings or similar.
• Handle scientific and data-related queries.
• Collaborate with statistician in data review and interpretation.
  
  

Safety & Efficacy

• Collaborate with the medical monitor and/or clinical safety scientist to identify any trial-related safety trends, and as needed, generate reports to interpret, analyze and summarize the data and trends.
• Collaborate with the statistician to identify any trial-related efficacy trends, and as needed, generate reports to interpret, analyze and summarize the data and trends.
• Other tasks as assigned by Study Sponsor or direct supervisor.
  
  

Education And Experience

• 2-4 years of clinical development experience (pharma, CRO) with M.D./D.O. or equivalent foreign degree.
• 1-3 years of experience in clinical development within Industry (pharmaceutical, CRO).
• Previous experience designing and developing phase 1-4 protocols.
• Therapeutic area experience (demonstrable with 2 or more years relevant experience).
• Demonstrates ability to analyze and interpret data, assess clinical relevance and present/report findings (e.g., ISS, ISE, competitor data, etc.).
• Proven current working knowledge of ICH E6 GCP and required local regulations, applicable and/or related to the performance of role duties and activities.