Job description

Director Medical Affairs Lead, United States

Conshohocken, Pennsylvania, United States

Director, Medical Affairs Lead, United States

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

This position is located in Conshohocken, PA or Rockville, MD.

The role:

The Director, Medical Affairs Lead is a key role in the Immunocore Medical Affairs team and is responsible for tebentafusp (KIMMTRAK) Medical Affairs strategy and activities in the United States.

The role will be responsible for developing and implementing the Medical Affairs strategy for KIMMTRAK (tebentafusp) in the United States and aligned with the global strategy as set by the Head of Medical Affairs. The Director, Medical Affairs Lead will lead scientific and medical communications for KIMMTRAK with including oversight of all US medical communications/education, congress planning, HCP engagement and Advocacy engagement. The Director, Medical Affairs Lead will work closely and collaboratively with the Life-Cycle Management (LCM) Lead in Clinical Development and the Global Product Team to develop the tebentafusp LCM strategy.  They will also   will work with the MSL team to discuss, review  and implement Externally Sponsored Research (ESRs) aligned to global strategy.

The Director, Medical Affairs Lead will lead and manage the Medical Science Liaison (MSL) organisation in the United States, leading their strategic deployment and supporting all activities including acting as initial point of escalation for medical enquiries from HCPs. The role will also  act as the primary point of contact with clinical development/operations to develop the strategy and medical affairs activities to support clinical development programs in the United States.

The Director, Medical Affairs Lead will play a key role in developing and fostering relationships with US KOLs, academic, institutional and governmental authorities in collaboration with the Commercial organization.   The Director, Medical Affairs Lead will develop relationships with Advocacy and Professional Societies, as well as act as the main point for collaborations and partnerships with these groups.  The Director, Medical Affairs Lead will provide initial review of advocacy grant requests and ensure appropriate review and approval of requests.  

Director, Medical Affairs Lead must have regular and continual training relevant to the role and training will include specific aspects of product identification and avoidance of falsified medicines  entering the supply chain.

Responsibilities:

  • The Director, Medical Affairs Lead is responsible to lead Medical Affairs activities in the United States in Uveal Melanoma (UM) and Cutaneous melanoma (CM), collaborating closely with the Head of Global Medical Affairs, the Clinical Development LCM Lead, and the Head of Medical Affairs for Europe/RoW.
  • Contribute to the development of integrated medical plans that include tactics to support key strategic imperatives for the KIMMTRAK in UM and CM.
  • Accountable for the alignment and execution of all activities of the US Medical Affairs plan, launch plans, and budgets.
  • Collaborate with relevant business partners to ensure alignment of medically appropriate brand strategy, planning, and execution.
  • Collaborate with LCM lead, Global Product Team, and Head of EU/ROW  to ensure that the data generation strategy is aligned with business and Medical Affairs’ objectives.
  • Interact with strategic partners, including advocacy, payer, and provider groups.
  • Interact with leaders in UM and CM (external experts/KOLs, Academic Institutions, and Professional Societies).
  • Play an integral role in the planning and participation of national and regional medical advisory boards and speaker training.
  • Collaborate with Clinical Development LCM lead to ensure that the Externally Sponsored  Research (ESR) program is aligned with strategy and executed appropriately in the US.
  • Provide strategic guidance and leadership to the US Medical Science Liaisons, working in close collaboration with the senior MSLs to develop the US MSL Medical objectives.

      Medical & Personal Leadership

  • Develops and maintains in a self-driven manner outstanding knowledge of immuno-oncology and relevant disease areas.
  • Develops and maintains in a self-driven manner outstanding knowledge of Immunocore products, competitor products, and other therapeutic options within therapeutic area.
  • Collaborates with cross functional team to ensure the best patient care.
  • Maintains an in-depth understanding of the medical strategy and broader Immunocore strategy to ensure their own) activities are coordinated with the team and aligned to strategy within Immunocore.
  • Maintains and develops synergistic relationships with KOLs  to expand research, advisory, and educational partnership opportunities.
  • Works to the highest ethical compliance, ethics and safety standards adhering to all local regulations and laws.
  • Engages with cross-functional team to ensure (their own) activities are coordinated with the team and aligned to strategy within Immunocore.
  • Support Medical Operations and global medical affairs in creating and implementing/optimising processes related to externally sponsored research, medical information/call centrer operations, field operations, insight gathering and processing and external medical communications.

      Education/ Communication

  • Develop and execute the US market specific Medical Communications plan in close coordination with the Commercial organization and aligned to global medical affairs plans.
  • Oversee the development of a consistent, well-integrated publication strategy across the company that is also compliant with both internal and external regulations.
  • Establish scientific communication and collaboration with HCPs and academia.
  • Act as final escalation point for US enquiries from the field and call centre following triage.
  • Take leadership where appropriate and engage with cross-functional team to ensure HCPs needs/issues are resolved with the ultimate goal of ensuring patients receive the best care.
  • Ensure that all interactions and activities adhere to corporate and healthcare compliance guidance in all activities, including those related to scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information.
  • Support review committees for medical affairs input and review, partnering closely with Regulatory, Legal and Healthcare compliance.
  • Act as an educational resource to internal stakeholders, providing medical/ scientific knowledge, training, and support on Immunocore products.
  • Support Commercial business plans including product communications, and review of promotional materials and activities of US  LMR committee.
  • Provide Medical support for communication with payor and health Technology Assessment organizations and support lifecycle management activities for key assets.

     Insight Gathering & Action

  • Key role medical affairs insight gathering processes and operations including leading on working collaboratively towards innovative solutions for identified issues in the US Market .

     Research

  • Work collaboratively with the LCM Lead to execute the externally sponsored research process in US and, in collaboration with the MSL team and other internal stakeholders, guide the collation and discussion/review of ESR proposals.
  • Provide strategic medical input to support clinical development activities.
  • Work collaboratively with Market Access to develop the HEOR/RWD generation plan.

Experience & Knowledge:

  • A Doctorate degree in Medicine (MD, D.O) desired; PhD or PharmD degrees will be considered with relevant experience; MS may be considered with extensive industry experience. 
  • Extensive Medical Affairs experience (5-7 years) from pharmaceutical industry or biotechnology, preferably in oncology, rare disease or immunology.
  • Experience in supporting brands or disease area levels in-country, regional or global organizations is preferred
  • Strong business acumen, including working knowledge of changing U.S. payer and provider landscape.
  • Proven ability to interact productively with both commercial and scientific/ medical colleagues.
  • Demonstrated ability to work collaboratively in cross-functional teams.
  • Experience in successful management of vendors and external teams in a matrix.
  • Demonstrable track record of working cross functionally on strategic planning.
  • Working knowledge of FDA and other relevant regulatory requirements.
  • Experience developing/and or launching a new pharmaceutical product/biologic product/indication, experience supporting a marketed product.
  • Effective communication skills with the ability to effectively present complex medical 

Qualifications: 

  • 10+ years of Pharmaceutical Industry medical affairs experience.
  • Knowledge of relevant Professional Societies and Scientific Medical Experts.
  • Immuno-oncology experience, Melanoma disease state experience, drug development experience.
  • Must be able to travel 30% of the time.

Lead with Science and Discover What is Within:

  • We value Entrepreneurship and Diversity
  • Respect, Trust, and Integrity
  • Competitive compensation
  • Medical benefits, beginning your first day of employment
  • Fully paid Dental Insurance
  • Vision Benefits
  • 20 days’ vacation plus holidays
  • Fully paid Life Insurance and Disability
  • 401(k) with Company Match

Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.

Immunocore is an E-Verify employer.  

 

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