- 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)
- 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
- 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
- Act as the Study Lead and, when needed, represent the program or disease area
- MD background with 3-5 years industry experience
- Experience in Oncology is strongly needed
- Prior experience as a responsible Medical Officer for clinical trial(s)
- Scientific background and/or deep understanding of solid tumor
- 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
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
- You are determined to do and be your best and take pride in enabling the best work of others on the team
- You are not afraid to grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so
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Medical Director - Utrecht, Nederland - Genmab
Beschrijving
The Role
& DepartmentGenmab continues to grow and is currently seeking a Medical Director to join our Medical Solid Tumor Team, focusing on early development/First-in-human trials.
As Medical Director at Genmab, you 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 position reports to the Vice President, Multi Compound Medical Head in Denmark.
Key responsibilities include
Requirements
Moreover, it is expected, that you have following:
This role can be located in Denmark, the Netherlands or the United States.
About You
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
