Sanofi Group Cardiovascular Medical Director - Bridgewater, NJ in Bridgewater, New Jersey
The Medical / Senior Medical Director represents a key role of all aspects related with Cardiovascular Medical Affairs responsibilities for a particular brand(s). Responsible to ensure strategic and cross-functional alignment to achieve the medical mission of supporting safe and appropriate use of a particular brand. With responsibilities in medical communications, safety, clinical trials, etc. Reporting to the Medical Unit Head or TA Head (VP or AVP), this position will occupy a key leadership role for one or more of the company’s products. Leadership role within a cross-functional team of medical professionals (health outcomes, biostatistics, clinical operations, medical communications, medical information, safety, regulatory and field liaisons) in planning and execution of all aspects of medical affairs product support.
Duties and Responsibilities
Leads the creation of the medical plan strategy and execution of tactics.
Responsible for creating strategies for an extensive US clinical trials program.
Provides medical leadership into the product marketing strategies.
Develops medical communication strategy and ensures its operational execution (abstracts, posters, publications, slide decks, oral presentations, etc.).
Identifies and communicates product alerts to the core team (in conjunction with U.S. Drug Safety, USRAMP, GMA).
Responsible for assessing core team members’ competencies and participation.
Leads the review and approval of IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOP(s) and develops a broad data generation plan / strategy, including ISTs.
Reviews approves and supervises all aspects of U.S. cardiovascular phase IIIB-IV clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans and clinical trial guidelines.
Oversees conduct of all clinical studies in adherence to both Company standards, and government/industry regulations (GCP/ICH).
Ensures final accuracy of clinical trials data and its timely availability (Clinical Study Repot), in appropriate format and works closely with Regulatory in developing plans for IND and/or sNDA submissions.
Supports and executes operational and tactical activities from the Medical Communication Plan as needed (publications, abstracts, etc.). Medical review and approval of promotional material (including concepts) in compliance with corporate standards and government/industry regulations.
Prepares a strategy for Independent Medical Education and executes the operational/tactical elements of the medical education processes (CME grants). Provides medical review and approval of regulatory documents pertaining to the work of the medical team.
Partners with U.S. Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the communication of identified safety signals.
Provides medical input to the product labeling, as needed. Provides professional medical expertise to Sales, Marketing and Legal functions on marketed products and drugs currently in approval process.
Assures alignment of initiatives across any existing Joint Ventures, including design and execution of all strategies and programs.
Develops and maintains close professional relationships with Key Thought Leaders (physicians and researchers) within pertinent medical community.
Fosters the establishment and maintenance of external scientific advisory boards and assists in advocacy development (in conjunction with RML). Remains informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc.
Maintains clinical and specialty expertise. Attends business team meetings, advisory board meetings, steering committee meetings.
Works in close collaboration with field medical team to support field medical work and collects medical insights from the field.
Collaborates with R&D, market access and business development support as required.
Supports/executes appropriate pre-launch and launch activities.
Supports the label development and updates as appropriate.
Knowledge, Job Skill or Equivalent Experience
M.D., D.O. from an accredited US or foreign medical school with three or more years of postgraduate medical training (PhD with appropriate qualifications also considered).
Board certified/eligible in Internal Medicine preferred or appropriate medical specialty/experience.
3-10 years total experience post medical degree, including clinical practice/residency specialty.
Prefer at least 5 years progressive experience in Pharmaceutical or Biotech Industry, working in Medical Affairs and/or clinical research and development or related fields.
Industry/academic experience in planning, executing and reporting clinical trials essential.
Strong leadership skills.
Strong interpersonal, verbal and written communication skills.
Strong understanding of Clinical Trials process with demonstrated ability to have designed and implemented programs and initiatives directed towards defined strategic objectives.
Strong understanding of GCP/ICH and FDA approval processes.
Languages: English required.
- Doctorate degree from an accredited college or university (e.g., M.D., D.O.)
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life