Medical Director, Scientific Affairs – milvexian
Johnson & Johnson
16 days ago
Remote friendly (Titusville, NJ)
United States
Medical Affairs
Medical Director, Scientific Affairs – milvexian
Responsibilities:
- Design and execute U.S. Scientific Affairs initiatives supporting milvexian (medical education, advocacy, evidence dissemination, and evidence generation).
- Collaborate with internal/external partners (Regulatory, Brand Marketing, Real World Value & Evidence, R&D, Global Medical Affairs, epidemiology, clinical investigators, advocacy organizations, and external experts).
- Own pharmacovigilance and medically important results assessments (MIRA) evaluations; support promotional review committee assignment, label revisions, and speaker/sales representative training.
- Provide support for training to meet current/future franchise needs.
- Ensure adherence to project budgets/timelines, participant safety/privacy, and compliance with applicable laws/regulations.
- Serve as disease-area scientific/medical expert and internal resource.
- Lead interactions with experts, including cross-functional partnership and promotional copy review/medical information service support.
- Develop/review regulatory documents for FDA submission; participate on the Safety Management Team.
- Partner with alliance companies when necessary.
- Develop relationships with thought leaders, scientific societies, and patient advocacy groups.
- Oversee education strategy and implementation of medical education and product training for HCPs.
- Conduct scientific engagement (advisory boards, symposia, congress activities).
- Ensure compliant evidence generation SOP handling for milvexian-related activities.
Requirements:
- Master’s degree required; advanced degree preferred.
- 8+ years of experience in clinical practice, industry, academia, and/or related area required.
- Pharmaceutical industry experience required.
Preferred:
- Cardiovascular disease or anticoagulation, drug development, and Medical Affairs experience/knowledge.
- Indirect team leadership; success leading clinical/scientific cross-functional teams.
- Understanding of U.S. healthcare dynamics.
- Prioritization, impact, decisiveness, urgency.
Skills (preferred):
- Analytical reasoning, clinical research/regulations, clinical trials operations, communication, stakeholder analysis, strategic thinking, workflow analysis.
Travel/Location:
- ~25% domestic travel; Titusville, NJ (Hybrid; 3 days on-site).
Benefits (if offered in posting):
- Medical/dental/vision/life insurance; short- and long-term disability; business accident insurance; group legal; retirement (pension/401(k)); long-term incentive; vacation (up to 120 hrs/yr), sick time (up to 40 hrs/yr; WA up to 56), holiday pay (incl. floating holidays up to 13 days/yr).
Responsibilities:
- Design and execute U.S. Scientific Affairs initiatives supporting milvexian (medical education, advocacy, evidence dissemination, and evidence generation).
- Collaborate with internal/external partners (Regulatory, Brand Marketing, Real World Value & Evidence, R&D, Global Medical Affairs, epidemiology, clinical investigators, advocacy organizations, and external experts).
- Own pharmacovigilance and medically important results assessments (MIRA) evaluations; support promotional review committee assignment, label revisions, and speaker/sales representative training.
- Provide support for training to meet current/future franchise needs.
- Ensure adherence to project budgets/timelines, participant safety/privacy, and compliance with applicable laws/regulations.
- Serve as disease-area scientific/medical expert and internal resource.
- Lead interactions with experts, including cross-functional partnership and promotional copy review/medical information service support.
- Develop/review regulatory documents for FDA submission; participate on the Safety Management Team.
- Partner with alliance companies when necessary.
- Develop relationships with thought leaders, scientific societies, and patient advocacy groups.
- Oversee education strategy and implementation of medical education and product training for HCPs.
- Conduct scientific engagement (advisory boards, symposia, congress activities).
- Ensure compliant evidence generation SOP handling for milvexian-related activities.
Requirements:
- Master’s degree required; advanced degree preferred.
- 8+ years of experience in clinical practice, industry, academia, and/or related area required.
- Pharmaceutical industry experience required.
Preferred:
- Cardiovascular disease or anticoagulation, drug development, and Medical Affairs experience/knowledge.
- Indirect team leadership; success leading clinical/scientific cross-functional teams.
- Understanding of U.S. healthcare dynamics.
- Prioritization, impact, decisiveness, urgency.
Skills (preferred):
- Analytical reasoning, clinical research/regulations, clinical trials operations, communication, stakeholder analysis, strategic thinking, workflow analysis.
Travel/Location:
- ~25% domestic travel; Titusville, NJ (Hybrid; 3 days on-site).
Benefits (if offered in posting):
- Medical/dental/vision/life insurance; short- and long-term disability; business accident insurance; group legal; retirement (pension/401(k)); long-term incentive; vacation (up to 120 hrs/yr), sick time (up to 40 hrs/yr; WA up to 56), holiday pay (incl. floating holidays up to 13 days/yr).