Overall Objectives and Purpose of the role
The Senior Director, Head of U.S. Medical Affairs will be responsible for all medical activities that are necessary to support Innate Pharma's US commercial organization. He/she will provide medical/scientific, strategic, and operational expertise into the planning and execution of U.S. medical affairs activities and may contribute to the global clinical development activities.
He/she will further build the U.S. Medical Affairs function, capabilities, culture and practices appropriate in size and scope for a rare, hem-oncology product (Lumoxiti®) with an advancing pipeline in oncology.
This person must have proven experience in leading and collaborating with teams and individuals in a global company. This person is accountable for U.S. Medical Affairs resources, budget, goals, objectives and performance metrics. He/she is expected to have a strong commitment to achieving objectives while maintaining the highest ethical, regulatory and scientific standards. This person must integrate medical and scientific insights and provide input to global strategies, plans and tactics.
The successful candidate will be viewed as a trusted senior leader within the organization. This position reports into the US General Manager, Executive Vice President.
and key tasks
|Lead US Medical Affairs Strategy across field-based and in-house medical affairs staff. Work collaboratively with US colleagues (35%)
- Lead the development and execution of the US medical affairs strategy, creating department goals, objectives and metrics to shape and define the success of the organization.
- Actively support the US commercial organization to promote the scientific and medical value of Company products, with primary focus on Lumoxiti®.
- Drive the engagement and establish appropriate strategic partnerships of centers of excellence, KOLs, professional societies and other key stakeholders in U.S. in areas of scientific and medical interest.
- Provide medical expertise and editorial support in the data dissemination from clinical and non-interventional studies at conferences and in medical journals.
- Strategically target relevant meetings to advance key objectives. Ensure appropriate staffing at major medical conferences.
- Ensure review of promotional and medical materials is medically appropriate and compliant with internal and external requirements.
- Develop effective scientific and medical presentations/materials that can be directly applied to support launch plans and enable strong prescriber and patient acceptance.
- Support Local Access and reimbursement activities, as needed (communicates medical part of value propositions).
- Create and update policies and procedures and guarantee conduct of medical and scientific activities according to all relevant regulations and SOPs.
|Provide leadership and direction to a team of Medical Scientific Liaisons (MSLs) and in-house Medical Affairs. (35%)
- Identify, hire, develop and manage medical affairs team, both field and in-house into a high performing team.
- Provide strategic leadership and direction for MSLs (currently 3) and work with them to broaden Innate's base of HCPs and KOLs.
- Conduct field rides with MSLs on regular interval across the US.
- Ensure field support of ongoing post approval studies and registries as directed by global medical affairs
|Work collaboratively with global colleagues (20%)
- Establish and promote productive working partnerships with global colleagues located in France and cross-functional resources as appropriate, working closely with Global Head of Medical Affairs based in Marseilles, France.
- Actively support the global commercial organization; participate in, support, and develop key global clinical and medical affairs strategies in conjunction with commercial and medical affairs counterparts.
- Provide ongoing and interactive technical and medical expertise to execute on these strategies.
- In collaboration with R&D and Commercial, plan for and develop non-registrational trials, secondary data analyses, and prepare timely and scientifically accurate publications.
|Oversight of US Medical Information and Call Center. (10%)
- Oversight of 3rd party vender who manages medical information and call center
- Create and update policies and procedures according to all relevant regulations and SOPs.
- Review and approve standard response letters and FAQs
- Ensure in-house scientific communications/in-house manager appropriately and compliantly manages day to day operations and interactions with 3rd party and internal stakeholders