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Sr. Director Global Medical Affairs – Solid Tumors

Employer
Genmab
Location
Princeton, New Jersey (US)
Salary
Highly competitive salary, incentives, and new hire equity grant. No-cost medical benefits.
Closing date
Jul 1, 2022

View more

Position
Medical Director
Category
Biotechnology
Hours
Full Time
Education
MD, PHD, MD / PHD
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Reporting to the Head of Global Medical Affairs Strategy (ST), the Global Medical Affairs Sr. Director will be the subject matter expert responsible for leading the development and execution of the Global Medical Affairs strategic and tactical plans including launch readiness and life cycle management for select solid tumor pipeline programs.

Job Responsibilities:

The Global Medical Affairs Sr. Director should have strong commercial aptitude and experience, including proven ability to translate and align commercial and scientific goals and objectives into actions. He/she will work as an integral part of the Compound Development Team and will in close alignment with Head of Global Medical Affairs Strategy (ST) and in close collaboration with the cross-functional partners, provide input and strategic direction for the program. He/she will also support data generation and life cycle management initiatives as well as establish and maintain the relationships with the Global Key Opinion Leaders.

Specific responsibilities for this role will include but are not limited to:

  • Develop and execute the overall medical strategy for designated products and/or therapeutic area
  • Serve on Global Clinical Development Team as Global Medical Affairs representative
  • Help identify and effectively interact with key thought leaders, patient advocacy groups and institutions to engage in scientific and medical exchange to meet the needs of patients, advance the field of study and Genmab programs Serve as the Medical Affairs lead on lifecycle strategy, including evidence generation strategy development and execution of Phase 3b/4 Medical Affairs led interventional and observational clinical trials Evaluate and manage Investigator Sponsored Trial program for an asset/or therapeutic area, including review of protocols and ongoing safety evaluations
  • Assure appropriate close coordination with commercial and marketing teams to support their efforts, including medical expert support of product pre-launch/launch
  • Play an integral role in the planning and execution of Global advisory boards and other Key Opinion Leader meetings related to an asset/or therapeutic area Collaborate with the field/regional teams and support reactive material development to address healthcare provider questions
  • Collaborate with medical information specialists on the development of medical information letters and documents
  • Coordinate with clinical operations, medical and translational medicine teams on strategic priorities and study support
  • Collaborate with medical communications on the preparation of manuscripts, abstracts and presentations for scientific meetings as well as other scientific communications initiatives
  • Contribute to the development of (and updates to) the yearly global publications plan for assigned product(s) and ensure optimal execution of plan
  • Provide guidance in the development of strategies to demonstrate the value of disease/products with a focus on outcomes meaningful to payer and clinical decision-makers Provide scientific/medical input into local regulatory/reimbursement/policy related documents and interactions Participate in medical review of branded and unbranded promotional materials, market access and health economics and outcomes research (HEOR) materials and medical communications materials to ensure accuracy, currency, scientific balance and compliance with internal policies and procedures Serve as a medical and content expert for internal and external stakeholders, including contribution of therapeutic area expertise for clinical development plans and presentations for internal training as well as external audiences Represent Genmab at key Global medical conferences/meetings Contribute to the development of internal guidance and resource documents Contribute as requested to the development/editing of departmental SOPs addressing processes and procedures necessary to achieve organizational objectives and for complying with government regulations and company policy. Ensures adherence to policies/procedures

Requirements:

  • Scientific or Medical Degree (Pharm D, PhD, MD) required 10+ 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
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