|Heading||Vice President of Medical Affairs|
Vice President of Medical Affairs SUMMARY OF POSITION The Vice President of Medical Affairs will build and manage the Medical Affairs team supporting the commercialization of migalastat in disease as well as future indications. He/she will work closely with our executive team to lead medical strategy, project execution, early access programs and Investigator Initial Trials, publications, medical information, medical education, and medical communications. The Vice President of Medical Affairs will be responsible for providing medical insight, guidance, strategy, medical review, competitive intelligence and training for commercial projects and business development programs while working with Market Access team to develop compelling medical evidence to support optimal patient access to medicines. He/she will develop the regional Medical Affairs strategies as well as provide operational guidance and oversight of US and Global activities related to Medical Information, Medical Communication, Pharmacovigilance, Medical Education, Investigator Initiated Research (IIT) and Key Opinion Leader (KOL) outreach. The Vice President of Medical Affairs will represent in scientific presentations, conferences and industry groups; serve as lead spokesperson with KOLs and interact with various Government agencies across the US and Europe, and support optimal life- cycle management. He/she will oversee compliance of all Medical Affairs activities with policies and procedures, local regulatory and legal requirements and ensure that appropriate systems and SOP/processes are in place. MAJOR ACTIVITIES AND RESPONSIBILITIES Build and lead the Medical Affairs organization, setting the strategic direction of all Medical Affairs functions across the organization. Represent and manage clinical programs in working with the Regulatory and Reimbursement agencies. Build partnerships and relationships with the scientific and medical community. Represent externally in scientific presentations, conferences and industry groups. Oversee the interpretation, publication/public disclosure, and accurate use of scientific data concerning migalastat in Fabry disease (as well as future products) and the development of scientific content for medical communication and scientific education initiatives. Provide strategic input into the development of Phase III b/IV trials, both Company-initiated and investigator-initiated, in collaboration with other stakeholders. Interact with key members of the medical community to assist in understanding current practice issues for Fabry disease, including developing and maintaining effective and optimal relationships with Key Opinion Leaders. Form and enhance working relationships with key external research collaborative groups. Actively participate and ensure Medical Affairs contributions to various teams and taskforces to build, support and defend the portfolio, in all facets of the business, with an emphasis on: Pricing and reimbursement Lifecycle management Ensure compliance of all Medical Affairs activities with all policies and procedures, as well as all local regulatory and legal requirements. Ensure that appropriate systems and SOP/processes are in place to meet these requirements. Drive a high performance culture by fostering innovation, customer focus, personal accountability and commitment for results. Lead medical strategies and project executions that support clinical development, including trial design and recruitment, early access initiatives, investigator initiated research/studies (IIRs/IISes), publications and other medical communications (e.g., medical information system, call center, etc.) Provides medical insights and guidance including strategy, medical review, competitive intelligence and training for key commercial projects and business development opportunities. Works closely with commercial team to develop compelling medical evidence to support optimal patient access to our medicines. Works closely with Patient & Professional Advocacy Works with headquartered and field-based medical teams (MSLs) to grow and manage a thought leader network to support successful implementation of plans. Ensures safe and appropriate use of medicines. ORGANIZATIONAL STRUCTURE The Vice President of Medical Affairs reports to the Chief Medical Officer. QUALIFICATIONS AND BACKGROUND REQUIREMENTS Educational Requirements MD required, board certified in internal medicine or pediatrics preferred. Professional Work Experience The ideal candidate will bring experience of extensive medical affairs leadership within the global biopharmaceutical industry, complemented by an understanding of the complexity of drug development dynamics for drug commercialization, launch and lifecycle management. More specifically they will have: 10 – 15 years of relevant academic, clinical and industry experience. Rare Disease experience highly desirable. Demonstrable executive leadership experience in Medical Affairs in a pharmaceutical/biotech organization, having led a regional/global medical affairs team. Track record of having played a central role (from a medical perspective) in product launches. Specific knowledge of the metabolic diseases field advantageous. Solid understanding of the US and European regulations that govern Medical Affairs activities as well as detailed knowledge of common local, medical practices and treatment habits. Experience in negotiations with pricing and reimbursement groups ideally across multiple EU countries, with the ability to shape and articulate the value story of specialty therapeutics along with proven lobbying and relationship building skills (e.g. with Payers, HTAs). Experience with products in the orphan drug arena would be advantageous, however more important is the understanding of specialty therapeutics addressing unmet medical needs. Demonstrated ability to maintain scientific credibility while being commercially supportive, and to communicate scientific results and effectively respond to data queries from customers and/or consultants. High proficiency in problem solving ability and strong scientific analytical skills. Experience with and understanding of the drug development process, including scientific understanding of basic physiology, pharmacology/biology, pharmacokinetics, and the role of preclinical studies in drug development. Proven leadership skills and building effective teams. Confidence and credibility to partner as peers with commercial counterparts. Demonstrated ability to work effectively in a matrix and global environment, and hold position without extensive medical infrastructure support. Will have clear alignment with values and culture including the ability and desire to interact with multidisciplinary teams, setting up a collaborative environment. Learning agile and ‘scalable’ to take on increasing responsibility and management as grows. Passion and fortitude to lead initiatives and willing to take stand to advocate for programs. Passion for science and strong professional customer and patient orientation. Excellent written and oral communication skills (in English), including strong formal presentation skills in front of internal and external audiences with the ability to “speak up” in meetings with scientific leaders and experts and to communicate in lay language in meetings with patients and caregivers. Ability to hire, manage and develop home-office based and field-based medical teams. Ability to define strategy and execute short- and long-term medical plans. Strong organizational and communication skills. Experience reviewing, approving and overseeing post marketing clinical studies.