Vice President, Medical Affairs Emea
Vor 3 Tagen
The Vice President, Medical Affairs is responsible for forging key opinion leader partnerships to accelerate a product's market penetration and expansion and for leading a senior medical team in EMEA. This role works closely with commercial and product development to support market success. The VP, Medical Affairs maintains strong understanding of, and compliance with, all applicable regulations and standard operating procedures. The position also ensures the highest scientific integrity and serves as liaison to external parties and institutions including the public, academia, the medical community, and government.
- Maintains positive professional relationships with the medical community, especially in the company’s specific discipline/product line to identify future business opportunities and emerging medical and health care practices
- Lead Medical Affairs team and is responsible for the successful delivery of project deliverables, on time and with quality focus
- Provide relevant consultation to project teams as needed
- As the organization’s primary information, industry and governmental liaison, keeps the organization informed on emerging and evolving industry trends, issues and business forecasts
- Leads, guides and motivates the EMEA senior medical team
**RESPONSIBILITIES**:
- Identifies, conceptualizes and activates investigator-initiated study concepts, along with investigators, to identify unique product characteristics
- Provides investigators with support for study development, accrual, completion and publication
- Maintains appropriate communication with Medical, Regulatory, and Legal personnel within the company to ensure appropriate timelines and procedures are met
- Develop strong product advocacy through KOL development by delivering quality medical education to internal and external colleagues
- Develops, and maintains and leverages collaborative relationships with current and future industry leaders to identify scientific communication opportunities
- Develop strategic thought leader plans to provide needs-based, value-added services and to improve their advocacy
- Manages clinical research and medical educational activities at targeted institutions with industry leaders and other key decision makers
- Manages and inspires the EMEA Medical Team to deliver first class performance in a growing environment and across several countries
- Coordinate EMEA medical activities with the US Medical Team
- Oversees activities to provide medical education for healthcare professionals through presentations at investigator meetings, advisory boards, and other appropriate venues to enhance product knowledge
- Identifies and communicates key clinical and research issues from industry leaders to appropriate departments to help shape company research, development, marketing plans and strategies
- Facilitates the identification of medical community training and educational needs for product introduction
- Maintains clinical expertise through aggressive education including attendance at relevant symposium, scientific workshops, preceptorships, and review of key journals
- May facilitate and/or deliver scientific/medical exchanges of information, or clinical and research findings of products through symposia, lectures and publications.
- Provides input and participate in cross-functional initiatives including field-based medical support to clinical research programs
- Participates in publication planning; slide-deck development, and training initiatives
**CORPORATE COMMITMENTS**:
- Demonstrate commitment and support for company goals, objectives and procedures
- Represent Reata by developing collaborative relationships with site personnel, colleagues and vendors
- Demonstrate professionalism and adherence to moral, ethical and quality principles
- Participate in corporate and departmental meetings
- Comply with applicable regulations, GCP and corporate policies and procedures
**QUALIFICATIONS**:
- Proven experience in leading and managing senior medical affairs staff at regional level and in EU4 + UK markets
- Completion of a doctorate level degree (MD) is required, with relevant residency and/or fellowship experience desired
- 8-10 years of relevant experience in a Pharmaceutical or Biotech environment
- Demonstrative relevant therapeutic research or substantive patient care experience is required (3 years minimum)
- Strong GCP and regulatory knowledge including FDA and ICH regulations
- Has an established track record of effective and influential oral presentations within the healthcare profession
- Experience with drug therapy positioning with a track record of influencing others to make accurate and effective therapeutic decisions is desired
- Demonstrates deep therapeutic competency - stays abreast of trends and new information in the profession
- Experience with expanded access program including operational and regulatory aspects
- Has significant experience with market access, and able provide
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