The Senior Medical Director, Medical Affairs, is responsible for the successful execution of Medical Affairs programs and deliverables through partnership with Medical Science Liaisons, Scientific Communications, Health Economics and Outcomes Research (HEOR), the Clinical Development organization, and others as appropriate. Additionally, forging productive and compliant partnerships with the Commercial organization and with our Alliance partner, Astellas, is essential. The candidate will report to the Vice President, Medical Affairs who, in turn, reports to the Senior Vice President, Medical Affairs.
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Essential Duties & Responsibilities
Provide leadership to the planning and execution of the Medical Affairs program strategy
Support Medical Affairs budget planning and management
Maintain high level of expertise on the disease area and serve as key medical resource in the disease area and on specific products
Expertly deliver scientific/medical information and clinical/research findings
Provide scientific leadership to the ISR Program, including review of proposed IST concepts and protocols, and concepts and protocols submitted by cooperative groups
Participate in the design and oversight of corporate-sponsored Medical Affairs trials, including concept and protocol development, with close collaboration with the study teams
Provide leadership to the Publications Committee, including review of publications, communications with authors, and participation in the development of the Publication Plan
Provide strategic leadership for the HEOR program
Provide support for Medical Science Liaison activities
Provide Medical expertise to the Commercial organization to compliantly assist in the development and execution of Commercial activities
Interface with external experts and health care professionals at major medical conferences, advisory boards, and other external meetings
Partner within the Organization to optimize cross-functional communication
Support effective coordination of partnership and internal Governance bodies
Support high-quality execution of Corporate-wide initiatives
Develop, track, execute and report on goals and objectives
Be accountable for compliant business practices
Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance.
Other duties as assigned
Core Competencies, Knowledge and Skill Requirements
Minimum of 8 years industry experience; oncology experience strongly preferred
Strategic and creative thinking
Ability to critically analyze research design, methods and outcome measures
Successful and superior influencing skills across all levels of the organization and external collaborators
Strong problem solving and risk mitigation skills
Strong time management and organizational skills
Ability to manage multiple projects in a fast paced environment
Ability to build working relations throughout the organization and with business partners to achieve business goals
Appreciation of diversity and multiculturalism
Prior training and experience with Good Clinical Practice (GCP)
PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Communication & Interpersonal Skills
Executive presence
Confident, positive attitude, enthusiastic and charismatic
Excellent and impactful verbal and written communication skills
Values based collaborator – respectful, accountable and collaborative
Ability to effectively collaborate in a dynamic cross-functional environment
Significant Contacts
Significant internal interactions, primarily among the different functional teams within Medical Affairs (including Medical Science Liaisons, Scientific Communications and HEOR), Clinical Development and Commercial
Significant external interactions, primarily with our Alliance partner, Astellas, experts and advocates within the prostate cancer community, and payer organizations
Education
MD degree required; subspecialty and board certification in oncology are preferred
Experience
Minimum of 8 years of experience and demonstrated success within another biotech/ pharmaceutical company, with 5 or more years in Medical Affairs are required
Professional knowledge and skills working with oncology and urology therapeutics in prostate cancer is strongly preferred
Understanding of Clinical Development and Commercial activities
Ability to partner effectively with Field Medical staff is required
Working knowledge of applicable Federal and State Compliance guidelines and regulations is required
Solid understanding of Health Economics and Product Access through Payers is strongly preferred
Experience with partnerships and strategic alliances is preferred
Prior experience with vendor selection and management is desired Working knowledge of applicable Federal and State Compliance guidelines and regulations
Licenses or Certifications:
MD degree
Travel, Physical Demands & Work Environment
Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)
Ability to work on a computer for extended periods of time.
Regularly required to sit for long periods of time, and occasionally stand and walk.
Regularly required to use hands to operate computer and other office equipment.
Close vision required for computer usage.
Travel required up to 25%
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