The Role
- Medical Director (Global Clinical Development)
Responsibilities
- Lead program strategy and contribute to the clinical development plan (CDP).
- Lead creation/review of clinical and regulatory documents (protocol, ICF, Investigatorβs Brochure, annual safety updates, study reports, and regulatory submissions such as IND/clinical dossiers) to support registration, market access, and commercialization.
- Oversee early-stage programs and develop clinical programs including component studies.
- Oversee drug safety, including patient safety and signal detection (with support of the Safety physician).
- Create and execute medical strategies; provide strategic medical advice on new projects (internal/external).
- Support clinical communication/publications and inputs to external presentations.
- Provide strategic input for clinical plans and trial protocols.
- Engage key opinion leaders to apply latest thinking/guidelines to development plans and explore novel methods/targets.
- Contribute to best practices, standardization, and cross-functional process improvements.
- Support case report forms, medical monitoring, investigator/site liaison, data analysis, author clinical study reports, and participate in advisory boards.
- Create medical deliverables (CDPs, concept sheets, briefing books, label/marketing application dossiers) and contribute to preclinical antibody development.
- Drive/monitor quality of clinical documents and participate in multi-function teams; attend congresses.
Requirements
- MD degree.
- 3+ years oncology clinical development experience; experience leading/supporting Phase 3 studies.
- Oncology clinical experience required; solid tumors preferred.
- Proven ability to build/lead teams; inspire trust.
- Experience representing organization internally/externally.
- Experience training/managing team members.
- Proven performance in earlier/comparable role.
Compensation/Benefits (US)
- Salary band: $202,800β$304,200.
- 401(k): 100% match on first 6%.
- Health: two medical options (incl. HDHP/HSA), dental, vision.
- Time off: paid vacation/sick/holidays; 12 weeks paid parental leave.
- Other listed benefits: voluntary insurance plans, backup care/resources, commuter/tuiton/Lifestyle Spending Account.