Medical Director

Genmab; Utrecht; Hybrid; EUR 188,697 - 255,297; Full time

Job summary

Genmab is seeking a Medical Director to oversee medical aspects of clinical trials, review data, and contribute to regulatory documents for antibody therapeutics. This role entails leading program strategies, drafting clinical and regulatory materials, and guiding cross‑functional teams in an international setting.

You will provide strategic medical input on trial design, publication strategy, and advisory boards, while ensuring alignment with safety and regulatory requirements.

Qualifications

• MD degree.
• 3+ years of oncology clinical development experience, including Phase 3 leadership/support.
• Clinical oncology experience; solid tumors preferred.
• Proven ability to build and lead teams and inspire trust.
• Experience representing team in internal/external settings.
• Experience training and managing team members.
• Proven performance in earlier or comparable role.

Responsibilities

• Lead development of program strategy for assigned trials/compounds and contribute to the CDP.
• Lead creation and review of clinical and regulatory documents supporting submissions.
• Oversee early-stage programs and develop clinical programs including component studies.
• Oversee safety of the drug and signal detection with support of Safety physician.
• Create and execute strategic medical plans for development programs.

Skills

Team leadership

Cross-functional collaboration

Mentoring

Stakeholder management

Education

MD degree

Job description

Medical Director – Global Clinical Development Team

Genmab is seeking an experienced Medical Director to oversee medical aspects of clinical trials, review data, and contribute to regulatory documents for our antibody therapeutics.

Key Responsibilities

• Lead the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP).
• Lead creation and review of clinical components of key documents, clinical and regulatory documents, annual safety updates, and registration dossiers (protocol, ICF, IB, annual safety updates, study reports, regulatory submissions – Briefing documents, IND, Clinical dossiers) supporting registration, market access, and commercialization of the compound(s).
• Oversee early‑stage programs and develop clinical programs including component studies.
• Oversee safety of the drug, including the safety aspects of patients in clinical studies and signal detection with support of the Safety physician.
• Create, integrate, and execute overall medical strategies of assigned clinical development programs; provide strategic medical advice on potential new projects (internal and external).
• Contribute to publication and clinical communication strategy in coordination with Scientific Communications; provide inputs to key external presentations.
• Provide strategic input and development support for clinical plans and individual trial protocols.
• Interact with key opinion leaders to ensure implementation of the latest clinical and medical thinking and guidelines into clinical development plans, and consideration of novel medical methods and new potential targets.
• Contribute to medical department best practices, standardization and to cross‑functional process improvements.
• Support the development of case report forms, perform medical monitoring, liaise with investigators and site personnel, perform preliminary and exploratory data analyses on clinical trials, author clinical study reports, provide input on publication materials, and participate in advisory boards.
• Support the development of other relevant documents that are necessary for the advancement of the product pipeline.
• Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors.
• Create medical deliverables: clinical development plans, concept sheets, briefing books, and label and marketing application dossier.
• Contribute to medical input to preclinical development of candidate therapeutic antibodies.
• Drive and monitor quality of all clinical documents (e.g., Investigators’ Brochures, protocols, study reports, clinical components of regulatory submissions, safety documents) produced by CDT.
• Participate in multi‑function teams necessary for the advancement of the product pipeline.
• Attend relevant congresses or other relevant fora to maintain up‑to‑date scientific/medical knowledge.

Requirements

• MD degree.
• Minimum of 3+ years of directly related industry experience in oncology clinical development, including experience leading or supporting Phase 3 clinical studies.
• Clinical experience in oncology required; experience in solid tumors preferred.
• Proven ability to build and lead teams and inspire trust among colleagues.
• Experience representing team and organization in a variety of internal/external settings.
• Experience training and managing team members.
• Proven performance in earlier role or comparable role.

Salary (US)

$202,800.00 – $304,200.00.

Benefits

• 401(k) Plan: 100% match on the first 6% of contributions.
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance.
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance.
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave.
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well‑being support.
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses.

Location

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work‑life balance. Our offices are crafted as open, community‑based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.