Genmab
Medical Director (Finance)
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 within oncology or hematology.
• Significant experience with relevant areas of oncology.
• 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:
$254,800.00---$382,200.00
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 bonuses.
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.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website .
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com) .
Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.