We are looking for an experienced and dedicated Medical Director to be a part of our Global Clinical Development Team (Hematology). 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.
This is a full time position that can be located either in Princeton NJ or Copenhagen DK. Partial remote/partial onsite work.
- Directing study design, protocol development and execution of clinical research for pivotal cancer studies.
- Contributing to the overall medical strategy of the assigned clinical development programs and product pipeline as well as giving in-depth medical advice on potential new projects (internal and external).
- Generating/reviewing clinical components of key documents (regulatory documents, registration dossiers, value dossiers, pharmacoeconomic dossiers) supporting registration, market access and commercialization of the compound(s).
- Ensuring quality of all clinical documents (e.g. Investigators’ Brochure, protocols, study reports, clinical components of regulatory submissions, safety related documents).
- Also, the Employee shall act as medical expert and have the ability to lead interactions with external stakeholders (e.g. regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups) internal stakeholders (e.g. Research, Translation Medicine, Safety, Regulatory, Global Medical Affairs and Commercial) and internal decision boards.
Moreover, the Employee shall:
- Oversee the safety aspects of patients in clinical studies and signal detection with support of the Safety physician.
- Plan and execute publication and clinical communication strategy in coordination with Scientific Communications.
- Provide input to key external presentations.
- Ensure career development of functional reports (esp. clinical research scientists) and other CMT colleagues through active participation in the performance management and talent planning processes.
- Provide on-boarding, training and mentoring support and contribute to the performance evaluation of CMT members as appropriate.
- The Employee shall also render such other related services and duties as may be assigned from time to time by supervisor.
- Participate in interviews of new potential hires for the Medical Department.
- Act as the Study Lead and, when needed, represent the program or disease area.
- Be proactive in interacting with the different line functions to ensure alignment with the objectives of the Medical Department.
- MD, background ideally with a minimum of 3+ years of directly related industry/academic experience within oncology or hematology.
- Experience as a responsible Medical Officer for clinical trial(s) from industry is required for Director Level.
- Scientific background and/or deep understanding of lymphoma strongly preferred.
- Ability to represent the Company in a variety of internal and external settings.
- Persuasive and effective in personal interactions at all levels of the organization.
- Demonstrated success in teamwork within a matrix organization and ability to inspire trust among colleagues.
- Innovative, flexible, resilient and visionary with the ability to seize opportunities.
- Ability to prioritize, respond to directives, and work in a fast-paced and changing environment.
- Result and goal-oriented and committed to contributing to the overall success of Genmab.
- Deep desire to make a difference.