Clinical stage biopharmaceutical company seeks a Medical Director to lead all functions of clinical development within the company. The Medical Director is responsible for the content, conduct of the clinical development program and clinical trials in this program. Our client has a drug that received FDA approval in Dec 2020 and another gene therapy product in phase 1 trials. All candidates for this role must be M.D.s.
Requirements for Medical Director – Clinical Development:
- MD required
- 10+ years of experience in clinical development or associated activities.
- Proof of concept and Phase 3 drug development experience
- Strong leadership skills with a commitment to collaborative leadership, and the ability to work cross functionally at all levels within an organization.
- Urology or gene therapy experience preferred
- Strong organizational skills, and a track record of accomplishment managing multiple competing projects
- Exceptional communications skills; oral, written, presentation and electronic
- The ability to work in different time zones, including international
- Thorough understanding of ICH Good Clinical Practices, clinical safety data management, clinical trials management (including protocol design, data management, site monitoring, statistical reporting, report writing), regulatory compliance and auditing including broad application of knowledge in different therapeutic areas.
Responsibilities of the Medical Director – Clinical Development
- Lead the cross functional clinical development team including vendors, contract research organizations and consultants,
- Lead medical input for associated programs.
- Develop the clinical development program and trial protocol in collaboration with vendors and consultants and clinical sections of investigator brochures, clinical study reports, presentations, briefing documents and submissions in collaboration with all functions, vendors and consultants.
- Provide input on business development activities and due diligence.
- Prepare clinical development program budgets, maintaining timelines with project manager.
- Provide guidance in internal process improvement activities as SOPs or guidance documents