Medical Director

About the role

We are looking for an experienced and dedicated Medical Director to be a part of our Global Clinical Development Team. The Medical Director will be accountable for the medical oversight of one or more clinical trials, medical review and communication of data, and medical input into regulatory documents and presentations.

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 (ie, 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 & 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, as well as consideration of novel medical methods development 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/comparable role.
• For US based candidates, the proposed salary band for this position is as follows:
• $202,800.00 - $304,200.00
• The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
• When you join Genm

Additional Information

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us!

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