Medical Director – Dupilumab, Atopic Dermatitis
Sanofi
full-time
Posted on:
Location Type: Office
Location: Cambridge • Massachusetts, New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $172,500 - $249,166 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Support 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).
- 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.
- Partner effectively with commercial organization to develop appropriate and scientifically rigorous promotional material.
- 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,ICMJE,ISPOR).
- 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).
- 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) and relevant professional societies within pertinent medical community to represent Sanofi and strengthen its reputation in the therapeutic area.
- Remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc.
- Identify data gaps to inform and execute integrated evidence generation plan.
- Provide leadership and strategic direction for interactions and communications with external customers, key organizations, and institutions.
Requirements
- MD/DO/Pharm D or PhD with prior experience in Dermatology or Immunology
- At least 5 years of industry experience in Medical Affairs/Clinical Development is preferred, including significant experience in Dermatology
- Sound scientific and clinical judgment, including an in-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale.
- In-depth understanding of and proven success in how to conceptualize, design, and conduct clinical trials.
- 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.
- Demonstrated excellence in collaborating with experts from other functions and influencing decision making without authority in a complex and matrix environment.
- Energetic with an absolute commitment to facilitating a culture that operates with high ethical standards and strives to exceed all goals and objectives.
- Demonstrated ability to inspire confidence while working effectively in a matrix environment.
- Comfort operating in a consensus-building role with ability to drive decision-making and implementation.
- Ability to inspire confidence, both internally and externally, in Sanofi Dermatology - leading by example and demonstrating collaborative behavior.
- Demonstrated ability to organize and lead expert Clinical Research Advisory Panels.
- Ability to understand and effectively communicate scientific and medical data to internal and external stakeholders.
- Excellent communication skills with the ability to build solid working relationships with the commercial organization
Benefits
- high-quality healthcare
- prevention and wellness programs
- at least 14 weeks’ gender-neutral parental leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trialsmedical reviewscientific reviewevidence generationbudget managementmedical communicationssafety data managementclinical researchregulatory compliancemedical leadership
Soft skills
leadership presencecollaborationinfluence without authorityethical standardsdecision-makingcommunicationrelationship buildingstrategic directioninspirationorganizational skills
Certifications
MDDOPharm DPhD