US Medical Director, COPD

Job Title: US Medical Director, COPD

Location: Cambridge, MA or Bridgewater, NJ

About the job

We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.​

Sanofi focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

Main Responsibilities

• Lead the development of an Integrated Medical Plan (MSLs, IME, Medical Communications and Publications, Health outcomes, Safety and Clinical Research (phase IIIB-IV and ISTs)) and annual budget for assigned brand(s).
• Monitor the execution of the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities or deliverables.
• Communicate the details and progress of the Medical Plan to Management, the Core Team and all parties responsible for execution.
• Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of a particular brand(s)/projects.
• Provide medical leadership and expertise to sales, marketing, legal and regulatory functions for marketed products and drugs in development.
• Provide medical review or support to the medical designee for scientific review and approval of promotional material and medical materials in compliance with corporate standards and government/industry regulations.
• Provide medical and scientific review and approval of promotional material and medical materials in compliance with corporate standards and government/industry regulations.
• Provide medical review of applications for independent medical education grants.
• Provide medical review of training materials for medical and commercial employees.
• Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law that mandates the nature in which pharmaceutical organizations function including but not limited to FDA, OIG, DDMAC/OPDP, PhRMA, CMJE, ISPOR).
• Review, approve and supervise all aspects of US phase 111B - IV clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, clinical trial guidelines and the accurate and timely reporting of study data.
• Oversee conduct of all clinical studies in adherence to both Company standards, and government/industry regulations (GCP/ICH).
• Review and approval of IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOP(s).
• Identify and communicate Product Alerts to the Core Team (in conjunction with U.S. Drug Safety, USRAMP, GMA).
• Partner 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.
• Develop and maintain 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).
• Remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc.

About you

Experience

• Greater than 5 years relevant experience in Medical Affairs.
• Advanced degree required (MD/DO, Pharm D, PhD)
• Area of specialization: Experience in respiratory/allergy therapeutic areas preferred.

Why Choose Us?

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.

The salary range for this position is $195,000.00 - 260,000.00.All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link, www.benefits.sanofiusallwell.com

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