Executive Director, Medical Affairs, Hematology Oncology

Location
Sleepy Hollow, New York
Posted
Jan 27, 2022
Ref
REGEA002625098BR
Required Education
Doctorate/PHD/MD
Position Type
Full time

The Executive Director of Medical Affairs will fulfill an important strategic leadership role reporting into the VP of Medical Affairs. He/ she has high visibility in the organization, participating with senior management in developing strategic objectives and implementing functional Medical Affairs plans for Hematology assets in phase 2 and beyond with the benefit of the patient at the forefront.

The Executive Director leads key Medical Affairs projects that require breadth of experience and strong business acumen. He/she brings innovation and critical thinking 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 assures optimal partnership for products developed in an alliance setting.

The Executive Director plays a critical role in establishing/maintaining professional relationships with key medical experts in the field of Hematology, all aspects of medical product support and appropriate collaboration with the commercial group.  The Executive Director ensures that all activities, internal and external adhere to rigorous corporate standards and government/industry regulations & compliance standards.

The Executive Director, Medical Affairs:

  • Responsible for directing, developing and enhancing one or more critical functions within the medical affairs department.
  • Ensures that strategic long term and annual conceptualization and execution of US and Global Medical Affairs plans for late stage Hematology) products/compounds are appropriately aligned with corporate strategies.
  • Plans strategically and executes, through line management where in place, appropriate medical support forHematology product(s) and candidates which includes, but is not limited to the following responsibilities:
  • Development and oversight of implementation of US and globally focused medical strategy and tactics, including internal/ external disease area/ product training, annual medical planning, scientific communications, and collaborations with experts.
  • Application of therapeutic/disease area expertise and addressing current and future medical needs in clinical practice to inform medically appropriate use of investigational medicines.
  • Providing strategic leadership and providing therapeutic area and medical affairs expertise for molecules in the development stage.
  • Oversight and hands on support in management, generation and dissemination of clinical and non-clinical data that supports the medical strategy and results in high quality publications.
  • Leadership to ensure an aligned and effective collaboration between Regeneron and a business partner’s Medical Affairs organization as well as the relevant business partner’s US and global franchise teams.
  • Standing or ad-hoc membership for various cross-functional and cross-alliance teams; providing medical perspectives to the global and US strategic and medical organizations.
  • Oversight of formation, refinement and execution of a robust Phase 3b/4 plan
  • Working closely with clinical sciences colleagues to optimize the development of phase 1, 2 and registrational trials.
  • Oversight of design, approval process, conduct, analysis and reporting of Medical Affairs clinical trials. Provides oversight to ensure timely submission and delivery of high-quality clinical trial documentation, implementation and execution.
  • Development and cultivation of long-term strategic partnerships with clinical experts, societies, collaborative groups, advocacy groups, and other external stakeholders representing Regeneron.
  • Oversight of Scientific Review Committee reviewing Investigator-Initiated Studies Research Proposals
  • Oversight of Medical Affairs representation on the Regeneron Copy Review Committee.
  • Champion of high standards of compliance, ethics and patient safety, putting patients at the center of all actions.
  • Staying abreast of current developments within pertinent medical and scientific therapeutic area through familiarity with current literature, attendance at medical society meetings, professional associations and other.
  • Accountability for creating and managing resources within annual Medical Brand Budgets, and expenses.
  • Performs oversight of medical monitoring of post-registrational trails and is the final signatory of documents related to interpretation of patient level data where necessary, if in possession of a medical degree 

Managerial responsibility and related expectations:

  • Directs, through line and matrix management, multiple functions and therapeutic areas within Medical Affairs.
  • Determines organizational structures and operational direction for one or more critical functions within medical affairs.
  • Is accountable for the overall organizational morale, team effectiveness and talent management
  • Leads by example and is viewed across the organization as a role model
  • Serves as principal spokesperson for the medical affairs function on highly significant matters
  • Interacts internally and externally with senior management and/ or functional heads requiring negotiation of difficult matters.
  • Takes on a positive leaderships role when there is ambiguity and little or no direction.
  • Provides guidance and fosters professional development and growth of direct reports.
  • Plays a key role in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
  • Speaks as principal spokesperson for the function or organization on significant matters.
  • Works 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.
  • Demonstrates excellent people management skills, as well as collaborative efforts with relevant stakeholders within and outside REGENERON.

Qualifications and skills:

  • Advanced degree (MD, PhD or PharmD), MD (Hematologist and/or Oncologist) strongly preferred
  • 14+ years total experience post (medical) degree, with at least ten years progressive experience in Pharmaceutical or Biotech Industry working in Medical Affairs and/or Clinical Research & Development or related fields.
  • Possesses clinical knowledge in a range of diseases within Hematology 
  • Industry experience in planning, executing and reporting clinical trials with post-marketing experience required.
  • Prior experience working in a matrix organization as well as cross-functional collaboration with commercial/marketing departments strongly desired.
  • Prior experience with working in an alliance setting strongly preferred.
  • Experience working in an alliance setting highly preferred.
  • Experience working with field-based colleagues/MSLs required.
  • US and global experience, including launch experience strongly desired.
  • Experience working collaboratively and coordinating with external partners
  • Demonstrates strong interpersonal, verbal and written communication skills. Ability to form strong and constructive internal as well as external professional relationships. 
  • Demonstrates a strong ability and desire 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.
  • Ability to lead business and technical discussions internally and externally and explain scientific/medical concepts to all levels.
  • Strong leadership and management skills.
  • Strong presentation and communication skills; must be able to provide succinct, strategic, and actionable insights to senior management.
  • Thorough understanding of the healthcare environment including all external stakeholders.

The ideal candidate will demonstrate the following competencies:

  • Ability to work effectively in a fast paced, rapidly changing and expanding environment and juggle multiple projects.
  • Outstanding work ethic and integrity, including high ethical and scientific standards
  • Strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict management skills, demonstrated by ability to lead teams.
  • Deals with scientific concepts and complexity with confidence.
  • Ability to engage in collaborative decision making, to complete tasks in a timely fashion, and function in a rapid-paced environment. Must be a practical thinker, able to identify simple, realizable solutions.
  • Makes the best decision possible based on a mixture of data analysis, wisdom, experience and judgement.
  • Creates a climate in which people want to do their best and can motivate many kinds of direct reports and team or project members.
  • Can deal comfortably with senior management.
  • Knows how to get things done both through formal channels and the informal network and can inspire and motivate teams across the organization.

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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