Medical Director

Princeton, NJ

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

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:

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.

Requirements:

MD background with a minimum 3 years of direct industry experience within oncology or hematology.
Experience as a responsible Medical Officer for clinical trial(s) is required.
Scientific background and/or deep understanding of solid tumor oncology is 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.

Additional Job 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 strategy 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

This is a hybrid position.

For US based candidates, the proposed salary band for this position is as follows:

$206,250.00---$343,750.00The 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

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

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.

When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.

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 https://www.genmab.com/privacy.

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.