Senior Director, Clinical Development

Senior Director, Clinical Development

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

• 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 and external documents and communications as needed.
• Work collaboratively with the clinical study team and other team members to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (CSRs, IBs, IND sections, CTAs, ISS and ISE sections and clinical expert reports).

Clinical Operations

• In collaboration with the Development Operations staff, develops the 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.
• Ensure development of study specific training materials for study team, investigational sites, and vendors.
• Participate and present at Investigator meetings or similar.
• Lead the responses to scientific and data-related queries.
• Collaborate with statistician in data review and interpretations.

Safety & Efficacy

• Act as the primary medical monitor with support as required to identify any trial-related safety trends, and as needed, generate reports to interpret, analyze and summarize the data and trends.
• Develop and/or review narratives for AEs/SAEs/AESIs as necessary.
• 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.

Qualifications

Education & Experience

• Board licensed MD (or equivalent foreign qualification) in Immunology
• Minimum of 8-10 years of Clinical Development experience (pharma, CRO) in Immunology/Autoimmunity
• Previous experience designing and developing phase 1-4 protocols.
• Therapeutic area experience preferred (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.).
• Experience working on a matrix cross-functional clinical team.
• Previous project management/clinical operations experience desirable.

Knowledge

• Demonstrated ability to manage multiple and diverse projects concurrently.
• Demonstrated ability to develop relationships and generate collaborations.
• Strong analytical skills; a strategic thinker, planner and implementer; proven negotiating track record.
• Solid Medical/Scientific writing skills required with appropriate clinical, scientific and medical knowledge to author and design and implement clinical protocol and other study documents.
• Working knowledge of statistics, data analysis and data interpretation.
• Experience with the operation aspects of clinical trials and related activities such as investigator meetings, DSMB's and GCP/ICH are necessary.
• Excellent written and oral communication skills.
• Organizational and cross functional collaboration skills.
• Proficient in Microsoft Office Suite of Programs

Skills & Abilities

• Strong interpersonal and communication skills (verbal and written) bridging scientific and business needs, integrating clinical science, disease area knowledge, and operational requirements.
• Incumbent must be able to work with colleagues at all levels of responsibility and authority.
• Ability to work on multiple projects with aggressive timelines
• Action oriented, flexible, able to adapt to changes in priorities, projects, and daily activities.
• Strong presentation skills
• Strong MSP skills

Physical Requirements

• Up to 20% travel