Executive Medical Director, Global Medical Affairs

 Position Summary: 

The initial prioritized focus for this role will be on strategic implementation and execution of key medical initiatives that support the U.S. launch of the company’s compound in myelofibrosis and Co-Chair oversight of the company’s IST and EA programs. Based on a deep scientific understanding of the disease area, unmet medical needs, treatment options and medical issues, the Global Medical Director, Medical Affairs will enable the organization to develop tailored medical solutions suitable for all supported established brands. 

 

 Duties and Responsibilities: 

• Provides medical expertise and strategic medical insights into the company Medical Affairs strategy and initiatives, specific to launch and post-approval activities in the US and other regional areas aligned to the regulatory planning process 
• Serves as Chair/Co-Chair of the Investigator Sponsored Operating Committee (ISTOC), driving strategic insights and medical relevance of concepts and protocol discussions 
• Oversees and assists in review of company supported Investigator Sponsored Trials (ISTs) and collaborates with Clinical Development and other key internal stakeholders, in the corporate plan and communication for clinical trial results 
• Lead Ad Board discussions and travel to meet with principal investigators, HCPs, and field-based the company’s employees. 
• Leads the Cross-Functional aligned strategy for the comprehensive IST corporate strategy 
• Maintains oversight of required Medical Approvals for Expanded Access Program (EAP) both in US and globally, with required review and approval of patient assessment forms (PAFs) and determination of medical eligibility for EAP 
• Supervises Phase IV clinical trials, acting as the intellectual driver behind a comprehensive scientific strategy for late-stage trials aimed to integrate, expand, and complement data from Clinical Development 
• Serves as “Safety Officer”, MD of record, for all assigned late-stage clinical ISTs and EAP program, with connectivity to Safety/PV reports and site notification 
• Leads the Medical Review for approval of company resources and materials for external use 
• Contributes to the agenda and leads advisory boards, investigator meetings, external medical strategy forums, and other key internal and externally focused meetings, as necessary 
• Acts as a senior Medical Affairs consultant and therapeutic area expert to internal stakeholders such as the MSL team, Commercial Organization, Regulatory and Clinical Development 
• Establishes high-level relationships with global Key Opinion Leaders, as well as with global Regulatory Decision-makers, Cooperative Groups, Academic Societies, and Patient Advocacy organizations, as appropriate 

Experience & Education Required: 

• Required: • MD degree 
• 10+ years’ experience in the pharmaceutical industry, within Medical Affairs, or equivalent combined clinical practice experience 
• Training and / or experience within myelofibrosis, MPNs or malignant hematology 
• History of successive leadership roles 
• Experience in direct patient care and / or patient-centered outcomes clinical expertise 
• Demonstrated familiarity with PhRMA code of conduct and with regulatory guidelines as they pertain to Phase IV activities 
• Preferred: Experience in planning and execution of Phase IIIb/IV clinical trials, scientific publications, presentations, and dissemination of clinical research data, strongly preferred 
• Experience preparing clinical protocols, interpreting, and reporting results to executive leadership and FDA, strongly preferred 
• Real World Evidence / Patient Reported Outcomes / Health Economics & Outcomes Research knowledge and/or experience, preferred 
• Full working knowledge of GCP guidelines, preferred 
• Experience working with regulatory agencies, preferred 

Knowledge, Skills, and Abilities: 

• Excellent communications skills and a track record of accomplishment in communicating across all levels of a highly matrix corporate environment 
• Ability to review and interpret complex clinical data and provide clear technical and analytical medical insights 
• Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance 
• Learns fast, grasps the ‘essence’ and can change the course quickly, where indicated 
• Raises the bar and is never satisfied with the status quo 
• Creates a learning environment, open to suggestions and experimentation for improvement 
• Embraces the ideas of others, nurtures innovation and manages innovation to reality 
• Medical acumen that includes staying up on new industry trends and innovation