Vice President, Head of Medical Affairs, Neuroscience

Ipsen•Cambridge, MA

10d•$382,000 - $425,000•Onsite

About The Position

The Vice President, Head of Medical Affairs, Neuroscience, will be a strategic partner for the assets under his/her responsibility, and will lead a dynamic US-based group overseeing the medical strategy and operational execution of all the multiple functions and therapeutic indications for all marketed products, products in development and provide expertise in business development, as required. As part of the responsibilities, this person will also oversee all life cycle management activities related to on-going Phase IV studies, as well as to closely interact with the R&D team and global medical teams to support registrational trials or global medical affairs sponsored trials. This individual will lead a team, including medical leads and medical directors, a publication and communications lead and work closely with the National Field Lead to ensure field execution.

Requirements

12+ years of pharmaceutical industry experience, including 5+ years in Medical Affairs with a focus on Neuroscience including spasticity management and other neurological conditions including migraine; minimum 3 years in the U.S. market.
Extensive expertise in Neuroscience, with deep knowledge of the unique aspects of toxin development and regulatory standards for approval/labelling, drug development and commercialization, and prior business development experience evaluating neurology assets.
Knowledge and expertise in HEOR, scientific publications, Clinical Operations and MSL role remit.
Knowledge of clinical trial design, execution, and biostatistics.
Proven leadership in Medical Affairs, including experience developing medical plan strategies, managing cross-functional teams across global Medical, R&D, Commercial, and Regulatory functions, and providing effective oversight of Medical Affairs teams representing multiple functional areas.
Demonstrated adaptability and leadership in a dynamic, cross-functional environments.
In-depth understanding of North American and global regulatory frameworks for neuroscience product development and commercialization, including reimbursement negotiations.
Experience analyzing, interpreting, and reporting scientific results of clinical studies.
Strong scientific communication and instructional skills, both written and oral, including the ability to summarize and present complex medical data to diverse audiences (e.g., patient groups, scientific meetings, regulatory bodies).
Demonstrated experience in publishing and reviewing scientific content; skilled in delivering presentations, facilitating discussions, and providing clear, engaging instruction in both formal and informal settings.
Knowledge of Phase IV program development, specifically management of observational studies.
Ability to develop and maintain credible relationships with top tier experts in Neuroscience and Physical Medicine and rehabilitation; existing network of such relationships is preferred.
Strong ethical standards and demonstrated awareness of regulations governing promotional activities.
Highly developed interpersonal skills and demonstrated people leadership in similar roles.
Excellent planning and organizational skills.
Ability to work independently and collaboratively across cross-functional teams.
Ability to travel – 35% is required
Advanced scientific degree required, MD, doctorate level clinical/medical degree (e.g., MD, DO, PharmD, PhD, Nursing doctorate)
Fluent in English

Nice To Haves

Board eligible or certified MD in relevant therapeutic area preferred
Experience in development programs preferred

Responsibilities

Provide input and influencing the global therapeutic area and each asset strategy, by providing expertise and ensuring strategic alignment between the US and the Global Medical Oncology
Oversee and ensure alignment with the US medical lead as member of the Asset Team and the Global Oncology Medical team
Support the evolution of the global and US business strategy to expand on the increasing number of assets and impact to the overall organization
Accountable for preparing arrival of new assets, from input into business development to contribution to registration studies, when required and preparing the strategy and organizational readiness and team structure ready for launch
Ability to influence internal and externally, manage and navigate complexity and display of leadership skills across the organization
Direct all the activities in US medical affairs, which include: Build, update and maintain the US organization for the therapeutic area according to the strategic business needs
Lead the medical strategy and medical planning for US NA Neuroscience Ipsen products.
Oversight of the Medical Directors for Clinical Studies and Early Access programs in the therapeutic area.
Have in-depth knowledge of Ipsen’s programs in order to support and facilitate integration of evidence portfolio into literature, medical publications, presentations at scientific meetings, and other forms of external communications.
Coordination and development of appropriate medical plans in collaboration with global medical affairs and other relevant internal partners
Oversight of the Phase IIIb/IV US studies, Investigator Sponsored Studies and R& D studies with US involvement in close collaboration with the global R& D and medical affairs teams
Accountable for the development and communication of appropriate publication plans
Oversight of all publications including posters, abstracts, manuscripts both at the US and global level to ensure appropriate alignment between relevant teams
Work closely with HEOR to ensure development of appropriate HEOR plans, supervision of on-going data generation projects as well as responsible to provide guidance for new projects
Frequent communication with the MSL team via the US MSL Leads. Ensure appropriate and timely training on new data is provided to the team, support answering questions from the team
Lead and oversee the management of appropriate relationships with health care professionals and professional organizations, patient advocacy groups, and educational foundations, and be recognized as the expert face of US Neuroscience Medical
Represent the medical function for review and approval of communication materials according to corporate and government/industry standards and regulations.
Lead the review, approval, and implementation of investigator-initiated study activities.
Support the development and implementation of Ipsen Neuroscience assets across managed access programs.