Senior Director, Clinical Development

Overview

Job Title: Senior Director, Clinical Development

Requisition: JR Senior Director, Clinical Development (Open)

Location: Bridgewater, NJ

Additional Locations: Malvern, PA;
Philadelphia, PA

The Senior Director, Clinical Development (CD) provides expert clinical advice across all phases (phase II–IV) of clinical research and serves as the responsible clinical lead from the Clinical Development function. They oversee the clinical development execution aspects of programs, typically across multiple study programs or therapeutic focus areas, and establish a resource model utilizing internal and external resources as needed. This role has ultimate oversight for leading CD activities including design and development of clinical studies, writing required clinical documents (e.g., protocol concept form, clinical study synopsis, clinical study protocol, investigator brochures), and ensuring on-time achievement of study and program milestones in alignment with program strategy.

The role also serves as 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, and Advisory Boards.

• Acts as the lead clinical representative on Project Teams.
• Contributes to development of clinical development strategy across multiple indications.
• Develops, reviews, guides, and approves protocols, amendments, ICFs, and clinical sections of other documents.
• Oversees safety monitoring of ongoing clinical studies with appropriate support as needed.
• Interacts with and leads engagements with thought leaders within the respective therapeutic area/indication.
• Tracks CD deliverables with Program Management across all studies/projects.
• Leads identifying, contracting, and engaging subject matter experts and thought leaders in advisory boards and consultancy.
• Oversees maintenance and updates of the CD project folders/drives.
• Reviews the informed consent form (ICF) and ensures alignment with safety sections of the study protocol.
• Develops, reviews, and/or approves clinical and safety monitoring CRF pages.
• Collaborates in development of clinical development strategy across multiple indications.
• Participates in study team meetings, data monitoring committees, and steering committees as necessary.
• Identifies opportunities within the broader R&D portfolio and proposes indications and study design approaches to establish proof of concept; evaluates opportunities for in-licensing or mergers/acquisitions to expand the portfolio.

• Reviews, guides, and finalizes study documents such as Protocol Synopses, Protocols, Protocol amendments, and Administrative Change letters.
• Contributes to trial-related documents (IBs, ICF, CRFs, CRF Completion Guidelines, Study Execution and Monitoring Plans, Clinical Data Review Plan, Clinical Database specifications, statistical analysis plan, data management plan, safety management plan, medical monitoring plan, CSR, etc.).
• Performs regular and ad-hoc data reviews and prepares leadership-ready summaries/documentation.
• Ensures timely development of program-level documents, including abstracts, manuscripts, presentations, and other internal/external communications.
• Collaborates with the clinical study team to prepare abstracts, manuscripts, and presentations for external meetings and authors clinical sections of regulatory documents (CSRs, IBs, IND sections, CTAs, ISS and ISE sections, and clinical expert reports).

• Develops operational strategies for clinical research studies and development programs with Development Operations (PI selection, CRO selection, budgets, timelines).
• Participates in vendor selection, specification development, and management/oversight as needed.
• Develops study-specific training materials for study teams, investigational sites, and vendors.
• Participates in Investigator meetings or similar events.
• Leads responses to scientific and data-related queries.
• Collaborates with statisticians in data review and interpretation.

• Act…