Senior Director, Clinical Development

Job Title

Senior Director, Clinical Development

Requisition

JR000015604 Senior Director, Clinical Development (Open)

Location

Bridgewater, NJ

Additional Locations

Malvern, PA, Philadelphia, PA

Job Description Summary

Job Description

The Senior Director, Clinical Development (CD) is responsible for providing expert clinical advice across all phases (phase II-IV) of clinical research and will be the responsible clinical lead from the Clinical Development function. They will be responsible for oversight and management of the clinical development execution aspects of clinical development programs. Generally, the role will oversee multiple clinical study programs and/or therapeutic focus areas and establish a resource model to support those activities with both external and internal resources when / as indicated. This role has the ultimate oversight responsibility for leading CD activities including the design and development of clinical studies, writing in collaboration with Medical Writing,  the required  clinical documents such as, but not limited to, protocol concept form, clinical study synopsis, clinical study protocol, investigator brochures etc.  They are ultimately accountable for the on-time achievement of study and/or program milestones in alignment with the program team strategic imperatives.

 

 This position is also the clinical point of contact between internal teams and external groups such as clinical operations, vendors (CROs, central laboratories, etc.), investigators, regulatory authorities, medical affairs, Key Opinion Leaders, Advisory Boards, etc.

Key Accountabilities

Clinical Lead

• Acts as the lead clinical representative on Project Teams.

• Act as the key contributor in development of clinical development strategy across multiple indications.

• Develop, review, guide and approve protocols, and amendments, ICFs, and clinical sections of other documents.

• Oversee safety monitoring of ongoing clinical studies under their leadership with appropriate support as needed.

• Interact and lead engagements with thought leaders within the respective therapeutic area/indication.

• Track with Program Management 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.

• Reviews the informed consent form (ICF); ensures alignment with the related safety sections of the study protocol.

• Develops, reviews and/or approves clinical and safety and monitoring CRF pages.

• Act as the key contributor in development of clinical development strategy across multiple indications.

• Collaborates in study team meetings, data monitoring committee and steering committees as necessary.

• Helps to identify additional opportunities within the broad R&D portfolio; propose indications and study design approaches for establishing proof of concept and help to identify and evaluate opportunities for in-licensing or mergers/acquisitions that would expand the platform portfolio.

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 safety 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 Leadership.

• Ensure timely development of program-level documents, including, but not limited to, abstract and manuscripts, presentations, and various other internal a