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.
The Medical Director is responsible for providing clinical leadership, medical strategic advice and expertise for LIBTAYO within the Medical Affairs team. Key responsibilities are planning and execution of the medical affairs strategic plan, KOL engagement, scientific exchange and Life-Cycle-Management.
Lead the development of the medical plan (MSLs, IME, Medical Communications and Publications, Health outcomes, Safety and Clinical Research) and annual budget for assigned brand.
Lead and monitor the execution of the 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.
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.
This role will work collaboratively with other members of the Medical Affairs team, Affiliate Teams, R&D, Statistics, Marketing and Brand teams, and others as needed.
Oversee conduct clinical studies in adherence to both Company standards, and government/industry regulations (GCP/ICH).
Lead the review and approval of ISS (Investigator Sponsored Study) 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 MSLs).
Remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc.
Lead the US in peri-launch activities
Performs other duties as assigned.
Travel required, comprising approximately 30-50%
M.D., D.O., Ph.D., D.N.P., or Pharm.D
At least 5 years of experience in the biotech/ pharmaceutical industry and/or clinical practice/academic setting in the field of hematology/oncology.
At least 10 years of experience in hematology/oncology with a recent focus on skin cancer
Experience in both clinical development and patient care
Excellent communication skills with the ability to build solid working relationships with commercial organization as well as negotiate and influence across cultures
Ability to understand and effectively communicate scientific and medical data results and information to internal and external stakeholders
Demonstrated ability to organize and lead Clinical Research Advisory Panels
Ability to work with and effectively support cross-functional teams
Broad and formal leadership experience, including excellent “leadership presence” to represent Medical Affairs within the company, to other functions, and to leaders at every level
Strong interpersonal skills with the ability to influence others
Excellence in solving problems while exhibiting superior judgement and a balanced, realistic understanding of issues
A team player; ability to collaborate successfully with both internal and external colleagues
Excellent communication skills both written and oral, including strong presentations skills
The highest personal integrity; committed to ethics and scientific standards
High energy and absolute commitment to culture
Strong analytical skills, comfort managing through ambiguity
Understanding and success in dealing with different cultures
Ability to manage competing priorities and projects, requiring an excellent ability to prioritize and manage expectations
A team player; able to collaborate successfully with both internal and external colleagues.
Commit to customers
Act for change: innovation, challenge the status quo
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.
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