Medical Director, Dupilumab
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
The Medical Director, Medical Affairs, Immunology and Inflammation, will assume a medical leadership role in the strategic planning and execution of global and US medical affairs activities supporting the life cycle management for dupilumab with a focus on respiratory programs. He/she will ensure that the strategic long term and annual conceptualization and execution of Medical Affairs plans are appropriately aligned with corporate strategies. The Medical Director will plan and strategically provide medical and scientific expertise to core business strategy, brand and business development plans. He/she will collaborate and take medical leadership within cross-functional teams of medical, commercial and corporate professionals. The Medical Director will remain informed on pertinent medical and scientific therapeutic areas through familiarity with current literature and attendance at medical society meetings and professional associations. He/she will establish and maintain professional relationships with key medical/scientific experts in the fieldw of asthma, COPD and other immunologic disorders. He/she will serve as the Medical Affairs representative on the Regeneron Copy Review Committee which is responsible for the review and approval of all promotional, educational and related materials and will ensure medical and scientific accuracy of the materials/presentations.
Ensure that strategic long term and annual conceptualization and execution of Medical Affairs plans for dupilumab are appropriately aligned with corporate strategies. Responsibilities may include the following:
• Devise medical/scientific strategies and plans in support of brand/business development strategies for dupilumab in asthma and other indications in development
• Provides strategic input and day-to-day advice to the cross-functional Medical Affairs team in preparation for the product launch
• Lead the development of medical/scientific communication strategies and oversee execution of scientific/medical communication plans (i.e. abstracts and presentations at medical conferences, and manuscript preparations and publications).
• Participate in cross-functional discussions on ongoing clinical development programs for dupilumab in respiratory and other indications. Lead the development of strategies for investigator-initiated studies (IISs) and oversee a process for reviewing IISs and providing drug supply for approved studies when needed.
• Provide strategies and plans on life cycle management for asthma and expansion across other indications.
• Collaborate with cross-functional teams to review and provide HEOR input for late phase clinical studies
• Provides medical/scientific training for internal staff (field-based research & science manager [RSMs], Medical Specialists, professional representatives, and other internal personnel), also participate in Speakers Training within the scope of Speakers Bureaus.
• Build strong relationships with internal stakeholders and ensure continuous and consistent communication with key internal partners
• Provide medical support for Managed Care initiatives including presentations to Formulary Boards and decision makers.
• Develop and execute phase 4 studies and compassionate use (expanded access program) as needed.
• Function as the Medical Affairs representative on the Regeneron Copy Review Committee which is responsible for the review and approval of all promotional, educational and related materials supporting approved product, 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. Identifies and appropriately interacts with advisors (in accordance with OIG guidelines); lead 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.
• Proactively stay abreast of recent scientific/medical advancement within asthma, immunology and inflammation field, stay aware of competitors' development activities by staying current with literature, attendance at medical society meetings professional associations and other.
Managerial responsibility and related expectations:
• Identify with and actively communicate/apply company values on a consistent basis.
• Demonstrate Core Competencies as defined for Regeneron managers on a consistent basis.
• 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 an active member on cross functional teams. Lead a multifunctional team with line accountability to functional disciplines. Ensures teams conduct activities with appropriate sense of urgency.
• Demonstrate excellent 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.
Knowledge and Specialized Skills:
• Possess extensive clinical knowledge in asthma, allergy, immunology/inflammation, or related field.
• 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'.
• Effectively interact with and collaborates at all levels in the organization, including effective interface at the senior management level.
• 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.
• MD or DO preferred, PhD or PharmD will be considered; Medical/Scientific training and professional experience in pulmonology, allergy, internal medicine, rheumatology, immunology/inflammation, or a related field desirable
• At least 6 years in the Pharmaceutical or Biotech Industry in Medical Affairs or Clinical Development
• Experience in pulmonology, allergy, internal medicine, rheumatology or dermatology desirable
• Experience in planning, executing and reporting clinical trials desirable with post-marketing experience a 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
• US and global experience preferable
• Experience working collaboratively and coordinating with external partners
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.