The Role
- Oversee Genmabβs pivotal/registrational Clinical Development program(s) in Oncology.
- Accountable for medical input and execution of clinical strategy for specified projects.
- Provide managerial oversight for physicians working on programs under your responsibility.
- Act as medical expert with Health Authorities; act as Responsible Medical Officer (RMO) for assigned program(s).
- Create medical deliverables (clinical development plans, concept sheets, briefing books, and label/marketing application dossiers).
- Provide input to intellectual property strategy by translating organizational strategy into clinical strategy.
- Support business development/alliance management with medical input for in-licensing assessment and collaboration/due diligence/investor activities.
- Oversee and develop clinical projects including component studies; provide strategic input for clinical plans and study protocols.
- Lead medical/clinical/scientific input for ongoing studies and development options; contribute to identification/validation of new molecular targets and disease indications.
- Provide hematology/oncology expertise, including competitor knowledge.
- Supervise safety surveillance (Safety Committees); be on alert list at CROs.
- Provide ad hoc input to strategic initiatives, including preclinical development medical input.
- Contribute to pipeline advancement documents (Regulatory, ICH-GCP, Business Development, etc.) and participate in cross-functional teams.
- Establish relationships with internal and external collaborators; serve as medical/technical resource for clinical issues.
- Collaborate cross-functionally at congresses/KOL interactions to implement latest guidelines and medical thinking.
Responsibilities/Requirements/Skills
- MD/MBChB from an accredited institution; board-certified specialist qualification (or equivalent).
- >15 years clinical/academic/industry leadership, including >10 years oncology industry clinical trials.
- Strong clinical trial data analysis and scientific disclosure synthesis.
- Experience preparing for NDA/BLA with authorities (FDA, EMA/CHMP, PMDA, MHRA).
- Expertise in scientific/medical/commercial development of innovative product platforms.
- Strong written and verbal communication.
- Approximately 20% travel; office-based/Hybrid in Boston, MA.
Benefits (US first-year eligibility for regular full-time employees)
- 401(k) 100% match on first 6% contributions.
- Two medical plan options (incl. HDHP with HSA), dental, and vision.
- Critical illness, accident, and hospital indemnity.
- Paid vacation, sick leave, holidays, and 12 weeks discretionary paid parental leave.
- Backup care, family support programs, financial wellness tools, emotional well-being support.
- Commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Compensation
- Proposed salary band (US): $347,120.00β$520,680.00; may include discretionary bonuses/long-term incentives.