Medical Director, Scientific Affairs – milvexian
About The Position
We are searching for the best talent for a Medical Director, Scientific Affairs - milvexian located in Titusville, NJ. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. The Medical Director, Scientific Affairs is responsible for the design and execution of U.S. Scientific Affairs initiatives supporting milvexian (i.e., medical education programs, advocacy initiatives, evidence dissemination, and evidence generation). Strong collaboration with internal and external business partners including regulatory, brand marketing, Real World Value & Evidence (RW V&E), Research & Development, Global Medical Affairs, epidemiology, clinical investigators, advocacy organizations, and key external experts. Responsibility for pharmacovigilance, medically important results assessments (MIRA) evaluations, promotional review committee assignment, label revisions, speaker and sales representative training, and other similar activities. Support training to meet current and future business needs of the franchise. Adherence to project budgets and timelines, the safety and privacy of research participants, and compliance with applicable laws and regulations. Serve as a disease area scientific and medical expert and resource for internal audiences Provides clinical and scientific leadership through interaction with internal and external experts, including: Partnership across Medical Affairs, RW V&E, R&D, Brand Marketing, Regulatory Affairs, Global Medical Affairs, New Business Development, J&J Corporate Communications, and J&J Legal, field based Medical Affairs personnel Participates in promotional copy review and supports medical information service Responsible for development and review of regulatory documents for FDA submission Membership on Safety Management Team The Medical Director will effectively partner with relevant Alliance partner companies on those activities when necessary. Develop and fosters relationships with thought leaders, scientific societies, and patient advocacy groups Education strategy and oversight of implementation of medical education and product training activities targeted towards Health Care Providers (HCPs) Scientific engagement activities such as advisory boards, symposia, and congress activities Medical responsibility for milvexian related department sponsored evidence generation related activities, ensuring SOP/compliant handling
Requirements
- Master’s degree required
- A minimum of 8 years experience obtained in clinical practice, industry, academia and/or related area is required
- Pharmaceutical industry experience is required
- The candidate must have a mindset of prioritization, impact, decisiveness, and a sense of urgency
Nice To Haves
- Advanced degree preferred
- Experience and knowledge of cardiovascular disease or anticoagulation, drug development, and Medical Affairs is preferred
- Indirect team leadership is preferred
- Demonstrated success leading a clinical/scientific cross functional team is preferred
- Understanding of US healthcare dynamics is preferred
Responsibilities
- Design and execution of U.S. Scientific Affairs initiatives supporting milvexian (i.e., medical education programs, advocacy initiatives, evidence dissemination, and evidence generation).
- Collaboration with internal and external business partners including regulatory, brand marketing, Real World Value & Evidence (RW V&E), Research & Development, Global Medical Affairs, epidemiology, clinical investigators, advocacy organizations, and key external experts.
- Responsibility for pharmacovigilance, medically important results assessments (MIRA) evaluations, promotional review committee assignment, label revisions, speaker and sales representative training, and other similar activities.
- Support training to meet current and future business needs of the franchise.
- Adherence to project budgets and timelines, the safety and privacy of research participants, and compliance with applicable laws and regulations.
- Serve as a disease area scientific and medical expert and resource for internal audiences.
- Provides clinical and scientific leadership through interaction with internal and external experts.
- Partnership across Medical Affairs, RW V&E, R&D, Brand Marketing, Regulatory Affairs, Global Medical Affairs, New Business Development, J&J Corporate Communications, and J&J Legal, field based Medical Affairs personnel.
- Participates in promotional copy review and supports medical information service.
- Responsible for development and review of regulatory documents for FDA submission.
- Membership on Safety Management Team.
- Partner with relevant Alliance partner companies on those activities when necessary.
- Develop and foster relationships with thought leaders, scientific societies, and patient advocacy groups.
- Develop education strategy and oversight of implementation of medical education and product training activities targeted towards Health Care Providers (HCPs).
- Conduct scientific engagement activities such as advisory boards, symposia, and congress activities.
- Medical responsibility for milvexian related department sponsored evidence generation related activities, ensuring SOP/compliant handling.
Benefits
- medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Company’s long-term incentive program.
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
