- Lead annual medical planning for asset(s) ; Work closely with extended medical affairs functions (global and regional markets) to inform and implement overall medical strategy for designated products and/or therapeutic areas
- Lead and execute on engagement strategy with thought leaders, patient advocacy groups, professional societies and institutions
- Lead the planning and execution of Early Access Program, and investigator initiated trials program, within appropriate standards for compliance, quality, timeliness, and alignment with MASL
- Contribute and execute on the life cycle management of the asset (s)
- Drive collaboration with cross-functional teams (e.g. commercial, field/regional, medical information/communication, HEOR) to provide support, medical review, and medical expertise advice as required
- Collaborate with medical and clinical operations departments to coordinate the planning, execution, and management of clinical trial activities across medical affairs functions
- Contribute to effective publication planning to ensure consistent and meaningful scientific communication
- Contribute to the development of internal guidance and process/resource documents
- Contribute to development and review of regulatory documents for regulatory submissions
- Serve as medical reviewer and expert on promotional and medical review committees
- Inform development of strategies to demonstrate the value of disease/products with focus on payer and clinical decision-maker outcomes
- Lead the strategy team congress activity planning in collaboration with cross-functional stakeholders, and compiling of congress reports including key competitive intelligence
- Scientific or Medical Degree (Pharm D, PhD, MD) required
- Expertise in clinical landscape of solid tumors required; Knowledge of gynecological cancers and/or head & neck cancer is preferred.
- 7+ years of medical affairs or clinical development background in oncology
- Biotech / Pharmaceutical industry experience, with strong understanding of solid tumor drug development and medical affairs function
- Ability to work successfully under pressure in a fast-paced environment and with tight timelines
- Demonstrated ability to lead strategically, drive performance, build alignment, inform, negotiate, and collaborate across partnerships
- Ability to lead collaboratively across various internal stakeholders and develop trusted partnerships
- A strong ability to interpret and articulate clinical/HEOR data and the impact on development programs
- In depth understanding of compliance and regulatory requirements for pharmaceutical Medical Affairs, R&D and Commercial work
- Knowledge of evidence-based medicine concepts, applied biostatistics and health economics are desirable
- Demonstrated organizational skills to manage multiple projects simultaneously, prioritize projects effectively and communicate at all levels within the company
- Strong written and verbal communication skills (including presentation skills)
- Ability to travel internationally to conferences and meetings, which will include occasional weekend travel
- 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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Director, Global Medical Affairs Strategy - Princeton, United States - Genmab A/S
Description
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.
The Role
The Genmab pipeline comprises of robust and diverse antibody products in immuno-oncology and beyond. Reporting to the Global Medical Affairs Strategy Lead (MASL) the Director will be responsible for the development and execution of the Global Medical Affairs strategic and tactical plans for the asset(s) for the primary indication as well as new indications to expand into as part of the asset life cycle management. The Director should have a strong background and experience in the field of solid tumors, with proven ability to translate and align commercial and scientific goals and objectives into actions. Director will work as an integral part of the Medical Affairs Strategy Team in close alignment with Global Medical Affairs Strategy Lead and the cross-functional medical affairs cross functional partners, providing input and strategic direction for the program. Director will also support data generation and life cycle management initiatives as well as establish and maintain the relationships with the global thought leaders in support of the programs.
Responsibilities
$206,250.00$343,750.00
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
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 (KYSOTM) 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
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.
