Senior Medical Director, Medical Affairs, Oncology/Hematology

The Sr. (Medical) Director, Medical Affairs, Oncology / Hematology, will fill a strategic leadership role and report to the VP of Medical Affairs.  The Sr. Director participates with senior leadership in the strategic planning and execution of Medical Affairs plans for all Hematology assets (in phase II and beyond) within the area and has oversight of all activities both Global and US either through direct leadership or delegation of responsibility to subordinates.  The Sr. Director must have substantial breadth of experience within Medical Affairs and extensive experience in the commercialization of assets within the therapeutic area.

A day in the life might include the following activities:

• 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.
• Managerial responsibility and related expectations include:
• Directs, through subordinate management, multiple functions within Medical Affairs
• Leads by example with little to no direction and is viewed across Medical Affairs as a role model
• Interacts internally and externally with senior management and/ or functional heads requiring negotiation of difficult or challenging issues.
• Speaks as the principal spokesperson for the therapeutic area
• Develops/refines methods, techniques and evaluation criteria for projects, programs, and idviduals
• Work in a goal/objective oriented manner within formalized process to plan and execute annual goals in alignment with the corporate annual goals and core business strategy.
• Take leadership role and/or participate as active member on cross functional teams.  Lead a multifunctional team with line accountability to functional disciplines. Ensure teams conduct activities with appropriate sense of urgency.
• Demonstrate superior people management skills, as well as collaborative efforts with relevant stakeholders within and outside Regeneron.
• Accountable for creating and managing resources within annual Medical Brand Budgets, and expenses.

This opportunity might be for you if you have:

• M.D.. PhD or PharmD (MD preferred)
• At least 15 years total experience post terminal degree, including clinical practice, with at least 10 years progressive experience in Pharmaceutical or Biotech Industry working in Medical Affairs and/or Clinical Research & Development or related fields.
• Possess extensive clinical knowledge across a range of diseases within the therapeutic area.
• Industry experience in planning, executing and reporting clinical trials desirable with post-marketing experience plus.
• Prior experience working in a matrix organization as well as cross-functional collaboration with commercial/marketing departments strongly desired.
• Experience working with field-based colleagues/MSLs.
• US and global experience preferable
• 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.
• Demonstrate an analytical approach to problem solving and ‘evidence-based decision making’.
• Demonstrate strong interpersonal, verbal and written communication skills. Ability to form strong and constructive internal as well as external professional relationships. 
• Demonstrate ability to present complex (medical) information to others effectively.
• Able to take an active leadership role and guide cross-functional teams towards the desired outcomes.
• 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.
• Demonstrate a strong desire and ability to collaborate with the commercial/marketing organization in an appropriate manner to ensure commercial strategy, plan and execution incorporate medical input and direction.
• Ensure that all medical affairs activities in support of the product adhere to all relevant industry regulations and guidelines, such as OIG and The Company’s Code of Business Conduct and Ethics.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an expansive 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. #MDJOBSMA, #MDJOBS