Regeneron Pharmaceuticals Senior Medical Director, Medical Affairs, Oncology in Tarrytown, New York
The Senior Medical Director, Medical Affairs, Oncology will develop and lead the Investigator Initiated Study strategy and will chair the Scientific Review Committee for all Oncology Regeneron programs (Solid and Heme assets). The Sr. Medical Director will be responsible for driving the evidence generation strategy and execution, evaluating and ensuring the value and quality of all proposals, and aligning with all internal and external stakeholders. The Sr. Medical Director will also develop and lead the medical strategy and execution of the medical plan for early immuno-oncology pipeline assets, and will provide scientific and medical leadership at the Strategic Product Teams.
He/she brings innovation, critical thinking, and leadership to planning Medical Affairs related processes, determines organizational structures, directs cross-functional teams (including medical, scientific & commercial directors, biostatistics, clinical operations, safety, regulatory, marketing planning, business development and corporate communications) and ensures optimal partnership for products developed in the collaborative / alliance setting. He/she will stay current with pertinent medical and scientific therapeutic areas through familiarity with current literature, attendance at medical society meetings and professional associations. He/she plays a critical role to establish and maintain professional relationships with key medical experts in the field of Oncology/Immuno-oncology and will oversee all aspects of medical product support including collaboration with the Commercial group. He/she ensures that all activities, internal and external adhere to rigorous corporate standards and government/industry regulations & compliance standards. He/she will ensure both short and long term strategic conceptualization and execution of Medical Affairs plans for asset(s) are appropriately aligned with corporate strategies. He/she will plan and strategically provide medical/scientific support to core business strategy, marketing, business development plans, and corporate strategy.
A day in the life may include the following:
Plans strategically and executes through subordinate management and oversight where in place appropriate Medical Affairs plans
Devise medical/scientific strategies and plans in support of marketing/business development strategies
Application of therapeutic/disease area expertise and addressing current and future medical needs in clinical practice to inform medically appropriate use of investigational medicines
Provide strategic leadership and input and day-to-day advice to the cross-functional Medical Affairs team in preparation for product launch
Leads the development of medical/scientific communication strategies and oversee execution of scientific/medical communication plans (i.e. abstracts and presentations at medical conferences, manuscript preparations and publications).
Participate in cross-functional discussions of ongoing clinical development programs for all assets with the therapeutic area
Oversight and leadership of the formation and execution of a high quality Phase IIIb/IV plan.
Oversight and leadership of the design, approval, implementation, and conduct of clinical trials conducted by Medical Affairs within the therapeutic area.
Oversight and leadership of the review and approval of investigator-initiated research proposals
Strategic development and oversight of the implementation of Medical Affairs aspects of life cycle management for all assets within the therapeutic area.
Participate in HEOR research planning including analyses and interpretation of results from Phase II-IV and other sponsored studies including compassionate use (expanded access programs) as necessary
Development of strong relationships with internal stakeholders and ensure continuous and consistent communication with key internal partners
Oversight, leadership and direction for medical support of Managed Care initiatives including presentations to Formulary Boards and decision makers.
Oversight and leadership of Medical Affairs related internal and external training initiatives (RSMs, Medical Specialists, professional representatives, training of other internal personnel while also participating in Speakers Training within the scope of Speakers Bureaus).
Oversight of Medical Affairs representative on the Regeneron Copy Review Committee which is responsible for the review and approval of all promotional, educational and related materials in support of product launch, ensuring medical/scientific accuracy and compliance with Regeneron policies and regulatory/industry guidelines.
Establish/maintain appropriate professional relationships with key medical experts, researchers and academic institutions within pertinent medical/scientific community. Identify and appropriately interact with advisors (in accordance with OIG) and the planning/facilitation of scientific Advisory Boards as applicable.
Ensure well aligned and effective collaboration between Regeneron and a business partner’s Medical Affairs organization as well as the relevant US and global franchise teams.
This job may be for you if you:
Have an advanced degree (MD, PhD, or PharmD)
At least 15 years total experience post terminal degree with at least 10 years progressive experience in Medical Affairs and/or Clinical Development.
Industry experience in planning, executing and reporting clinical trials desirable with post-marketing experience plus.
Experience working with field-based colleagues/MSLs.
Experience working collaboratively and coordinating with external partners
Understand the clinical trials process with demonstrated ability to design and implement programs and initiatives directed towards defined strategic objectives.
Understand the FDA approval processes; understanding of regulatory approval process/requirements outside the US (eg EMEA) desirable.
Effectively interact with and collaborate at all levels in the organization, including effective interface at the senior management level.
Demonstrate ability to present complex (medical) information to others effectively.
Possess a desire to ‘jump in’ and collaborate with cross-functional team in supporting launch of a break-through product at an important time for the organization and willingness to ‘go the extra mile’ when needed.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
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