VP, Global Medical Affairs Lead for Nirogacestat
About SpringWorks Therapeutics
SpringWorks Therapeutics is a clinical-stage biopharmaceutical company that re-prioritizes promising science and pioneers efficient pathways for drug development for patients with severe rare diseases and cancer. We are a “start-up with a head start,” launched in 2017 with a portfolio of promising clinical therapies from Pfizer, two of which will be entering pivotal studies in the first half of 2019.
At SpringWorks Therapeutics, we ignite the power of promising science to unleash new possibilities for patients. We work hard, we care even harder and we’re in it together. We are looking for ambitious, smart and hardworking colleagues to join our growing team.
Are you a SpringWorker?
How much do you care?
How well do you partner with others?
How fast do you move?
Are you a problem solver?
Are you comfortable challenging convention?
Does this sound like fun?
We currently have an opening for a VP, Global Medical Affairs Lead for Nirogacestat who will report to the Chief Medical Officer.
About The Role
The VP, Global Medical Affairs Lead for Nirogacestat will drive the Global Medical strategy for the Nirogacestat franchise and work with various internal departments to identify business opportunities based on changes in the medical and regulatory environment. Maintains positive professional relationships with the medical community within the indications relevant for Nirogacestat. Identify current and future business opportunities and emerging medical and health care practices. Maintains working knowledge of local/regional health planning issues and trends and provide Medical strategic support and oversight to countries.
Specific responsibilities include
- Lead the Strategy development and execution of Global medical affairs plans and associated activities including publication planning, medical and scientific advisory boards, educational programs, conferences, and responding to requests for medical affairs
- Work in partnership with R&D, to optimize the clinical development plans in support of a reimbursable file and life cycle strategy for Nirogacestat.
- Evaluate health economics landscape and establish an outcomes research plan that can support reimbursement and commercial activity
- Remain at the forefront of science to understand medical and health care practices, the competitive landscape.
- Build on existing expanded access / compassionate use plans and in partnership with clinical development and regulatory, manage such a program
- Work with internal team to develop key messages on disease state, MOA, target product profile, diagnosis, etc.
- Gather medical insights from key external stakeholders (patients, physicians, payers, regulators) to inform and shape clinical development strategies.
- Accountable for the development of an integrated Medical Strategy for Nirogacestat and potentially additional products.
- Accountable for the execution of phase 3b and 4 studies, including post-approval commitments.
- Oversight of all Investigator Initiated Research (IRRs), including strategy and review process.
- Strong interaction (Internal and External) with key stakeholders to deliver evidence generation and evidence communication needs.
- Representation of SpringWorks at major External scientific and KOL events.
- Interaction with Governments, Payers and Patient Organizations.
- Speaking at major events which require SpringWorks engagement on scientific issues and topics of relevance to the business.
- Assist with continuous safety assessment of Nirogacestat
- Assist with development of asset specific HEOR plans
- Provide daily leadership to the Nirogacestat franchise
- Be a key member of the CMO’s Leadership Team
- Supervises medical information process and service in close collaboration with other functions in medical affairs
- Represent SpringWorks as an organization, and present data at advisory boards, clinical investigator meetings, and congresses
About You: Required Education, Skills, and Experience
- Leadership roles in Medical Affairs with demonstrated results.
- Experience in Country and above country Medical Affairs roles
- Experience in drug development (R&D)
- Scientific expertise in therapeutic area
Preferred Education, Skills, and Experience
- Preferably specialization in Hematology or Oncology.
- Organization SpringWorks Therapeutics
- Employee Status Regular Full -Time
- Benefits Competitive compensation and benefits package
SpringWorks Therapeutics is an Equal Employment Opportunity employer. All qualified applicants/employees will receive consideration for employment without regard to that individual’s age, race, color, religion or creed, national origin or ancestry, sex (including pregnancy), sexual orientation, gender, gender identity, physical or mental disability, veteran status, genetic information, ethnicity, citizenship, or any other characteristic protected by law.