Director, Clinical Development
About The Position
The Director/Senior Director, Clinical Development will be responsible for all clinical trial related activities for Brelovitug, a key asset in Phase 3 on a cross-functional team of internal and external experts, investigators and government agencies. Activities include but are not limited to protocol development, support study startup, oversight of trial execution, recruitment, ongoing clinical development management and closeout as appropriate. Compliance with internal processes, GCP/ICH and regulatory requirements, study and data monitoring, data analysis are required. Participation in health authority meetings and regulatory filing activities are also part of this role. The Director/Senior Director, Clinical Development operates in collaboration with other functions including internal Safety, Regulatory, Biometrics, and Clinical Operations teams.
Requirements
- MD, PharmD, PhD or equivalent is preferred with ≥3 years of drug development in industry, academia, or a related environment, working within cross‑functional project or program teams with proven success.
- Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe.
- Demonstrated accountability for delivery on clinical studies.
- Leadership in clinical development programs and multidisciplinary trial teams.
- Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance.
- Ability to understand and communicate risks, as well as develop and execute contingency plans.
- Ability to think creatively and develop and execute in a fast-paced environment.
- Detail oriented with exceptional organizational skills.
- Effective communicator with strong verbal and written skills.
- Ability to identify issues, analyze situations and provide effective solutions.
- Solid understanding of the clinical development process.
- Knowledge of applicable regulatory.
Nice To Haves
- Experience in Liver or rare disease a plus.
Responsibilities
- Leadership and management of all aspects of complex, global development clinical studies.
- Primary point of contact for clinical inquiries from sites, CRO and site monitors; answer or triage questions as appropriate integration of clinical/regulatory strategy into global product development strategy.
- Primary liaison for internal Clinical Operations for site selection, site start-up activities, study management and closeout activities, etc.
- Support the creation of and/or review of clinical slides for internal and external meetings (e.g. Investigator Meetings, SIVs, IDMCs, Advisory Boards, etc.)
- Assist in authoring key clinical study documents, including Protocols, Clinical Study Reports, Investigator Brochures, Regulatory Authority briefing books, Development Safety Update Reports etc.
- Strategic input on the overall development plan, internal and external evaluation of new studies
- Oversight of clinical aspects of compliance of and inspection readiness in completed, ongoing and starting clinical trials
- Collaboration in the analysis and writing of scientific publications/presentations
- Works closely with cross-functional team members
- Co-leads Study Management Team with Clinical Operations lead.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
