VP, Global Medical Affairs Lead for Nirogacestat
About SpringWorks Therapeutics
SpringWorks Therapeutics is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. SpringWorks has a differentiated portfolio of small molecule targeted oncology product candidates and is advancing two potentially registrational clinical trials in rare tumor types, as well as several other programs addressing highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with industry leaders to expand its portfolio.
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
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
Benefits Competitive compensation and benefits package
Springworks Therapeutics, Inc.