Sanofi Group Sr. Medical Director, Asthma Dupilumab in Cambridge (U.S.), Massachusetts
Sr. Medical Director, Asthma Dupilumab
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Genzyme Corporation (a Sanofi company)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.
Sr. Medical Director, Asthma, Dupilumab
- 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).
- Lead and 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 Senior 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.
- 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,ICMJE,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).
- Lead the 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.
8-10 years.Relevant experience in Medical Affairs
MD/DO preferred.Doctorate (PhD., Pharm. D. or advanced degree) with relevant experience.
Primary Location: United States-Massachusetts-Cambridge (U.S.)
Job Posting: Sep 8, 2016, 6:06:32 PM
Job Type: Regular
Employee Status: Regular