Director, Medical Affairs Strategy

6 days ago

Princeton, United States Genmab Full time

The Role

Reporting to the Global Medical Affairs Strategy Lead (MASL), the Medical Director will be the subject matter expert responsible for providing medical support to the development and execution of the Global Medical Affairs strategic and tactical plans and support the Global medical launch planning, and execution for epcoritamab in close alignment and collaboration with the MASL.

Responsibilities

As an integral part of the Global Oncology Medical Affairs Team, and in close collaboration with the MASL and cross-functional partners, the Global Medical Affairs Director should have strong commercial aptitude and/or experience, including proven ability to translate and align commercial and scientific goals and objectives into actions. He/she will advise on the development of medical education and publication/communication tactics and support the learning and development of internal stakeholders. 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:

  • Support the development and execution of Global Medical Affairs Plan

  • Provide medical monitoring and medical oversight for company sponsored Medical Affairs led interventional and observational clinical trials

  • Support cross-functional pre-launch/launch activities

  • Prepare and give presentations for internal training and to external audiences

  • Serve as a medical and content expert for internal and external stakeholders

  • Play an integral role in the planning and execution of Global advisory boards and other Key Opinion Leader meetings

  • Represent Genmab at key Global medical conferences/meetings

  • Provide input for Medical and Promotional Review Committees

  • Provide scientific/medical input into local regulatory/reimbursement/policy related documents and interactions

Requirements

  • Team player mindset

  • Relevant experience in Oncology (preferably within hematologic malignancies)

  • Preferably prior industry experience, ideally including pre-launch & launch experience within Oncology and/or Hematology

  • Ability to think strategically and analyze short- and long-term program impacts

  • Ability to lead collaboratively across various internal stakeholders and develop trusted partnerships

  • A strong ability to interpret and articulate data

  • Fair knowledge of evidence-based medicine concepts, applied biostatistics and health economics are desirable

  • Demonstrated skills to manage multiple projects simultaneously

  • Strong written and verbal English communication skills (including presentation skills) along with excellent judgment and ability to work in a matrix team environment

  • Ability to work globally across time zones and travel internationally to conferences and meetings, including occasional weekend travel

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.

  • Director, Medical Affairs Strategy

    2 weeks ago

    Princeton, United States American Society of Clinical Oncology Full time

    The Role Reporting to the Global Medical Affairs Strategy Lead (MASL), the Medical Director will be the subject matter expert responsible for providing medical support to the development and execution of the Global Medical Affairs strategic and tactical plans and support the Global medical launch planning, and execution for epcoritamab in close alignment and...

  • Director, Medical Affairs

    1 week ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries Full time

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE Hybrid work arrangement Medical, Dental, Vision Benefits Health Savings Account (HSA), Flexible Spending Account (FSA) Prescription Drug Coverage Telehealth and Behavior Health Services Income Protection - Short Term and Long Term Disability Benefits Retirement Benefits - 401k Company Match on Day...

  • Director Regulatory Affairs Strategy

    2 months ago

    Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...

  • Director Regulatory Affairs Strategy

    2 months ago

    Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...

  • Director Regulatory Affairs Strategy

    3 weeks ago

    Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...

  • Director, Medical Affairs

    1 month ago

    Princeton, United States Sun Pharmaceutical Industries Full time

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! * Hybrid work arrangement * Medical, Dental, Vision Benefits * Health Savings Account (HSA), Flexible Spending Account (FSA) * Prescription Drug Coverage * Telehealth and Behavior Health Services * Income Protection - Short Term and Long Term Disability Benefits * Retirement Benefits - 401k...

  • Director, Medical Affairs

    3 weeks ago

    Princeton, United States Sun Pharmaceutical Industries Full time

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! * Hybrid work arrangement * Medical, Dental, Vision Benefits * Health Savings Account (HSA), Flexible Spending Account (FSA) * Prescription Drug Coverage * Telehealth and Behavior Health Services * Income Protection - Short Term and Long Term Disability Benefits * Retirement Benefits - 401k...

  • Director Regulatory Affairs Strategy

    2 months ago

    Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...

  • Director Regulatory Affairs Strategy

    2 months ago

    Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...

  • Director Regulatory Affairs Strategy

    3 weeks ago

    Princeton, United States Lynkx Staffing LLC Full time

    Job DescriptionJob DescriptionOur Pharmaceutical client seeks a Global Director Regulatory Affairs Strategy to guide global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs in collaboration with counterparts, investigators, project team members, and consultants. Lead/support...

  • Sr. Director, Regulatory Affairs Strategy

    3 days ago

    Princeton, United States Sun Pharma (Taro Pharma) Full time

    Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...

  • Sr. Director, Regulatory Affairs Strategy

    1 week ago

    Princeton, United States Sun Pharma (Taro Pharma) Full time

    Job DescriptionSenior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs.  Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the...

  • Sr. Director, Regulatory Affairs Strategy

    2 days ago

    Princeton, United States Sun Pharma (Taro Pharma) Full time

    Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs.  Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...

  • Sr. Director, Regulatory Affairs Strategy

    1 week ago

    PRINCETON, United States Sun Pharma (Taro Pharma) Full time

    Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs.  Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...

  • Sr. Director, Regulatory Affairs Strategy

    7 days ago

    Princeton, United States Sun Pharma (Taro Pharma) Full time

    Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs.  Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...

  • Senior Director, Field Medical Affairs

    4 weeks ago

    Princeton, United States Apsida Life Science Full time

    Job Title: Senior Director, Field Medical AffairsClinical-Stage Biopharmaceutical CompanyHematology-oncology/diffuse large B-cell lymphoma Headquartered in Princeton, NJ Position Overview:We are seeking a dynamic and experienced Senior Director, Field Medical Affairs to join an innovative team at a highly reputable clinical-stage biopharma headquartered in...

  • Senior Director, Field Medical Affairs

    3 weeks ago

    Princeton, United States Apsida Life Science Full time

    Job Title: Senior Director, Field Medical AffairsClinical-Stage Biopharmaceutical CompanyHematology-oncology/diffuse large B-cell lymphoma Headquartered in Princeton, NJ Position Overview:We are seeking a dynamic and experienced Senior Director, Field Medical Affairs to join an innovative team at a highly reputable clinical-stage biopharma headquartered in...

  • Associate Director Medical Affairs Operations

    1 month ago

    Princeton, United States ACADIA Pharmaceuticals Inc. Full time

    Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. The Associate Director will support the strategic direction and oversee the tactical execution of operations for the Medical Affairs (MA), Rare Disease supporting the DAYBUE (trofinetide) launch and...

  • Associate Director Medical Affairs Operations

    3 weeks ago

    Princeton, United States ACADIA Pharmaceuticals Inc. Full time

    Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average. The Associate Director will support the strategic direction and oversee the tactical execution of operations for the Medical Affairs (MA), Rare Disease supporting the DAYBUE (trofinetide) launch and...

  • Sr. Director, Regulatory Affairs Strategy

    2 weeks ago

    Princeton, NJ, United States Sun Pharma (Taro Pharma) Full time

    Senior Director, Global Regulatory Affairs Strategy   The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...