Vice President Medical Affairs

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Company: Strategic Search Group
Location: Waltham, MA

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VP, Medical Affairs -Reporting solid line to the Head of North America, this position is responsible for establishing, executing and leading a modern, innovative, integrated medical function within North American including strong field representation, KOL engagement, Scientific Affairs, Healthcare compliance, Medical Information, Safety, Clinical Operations.

Including, but not limited to the following

• • Recruitment, management and development of medical team in North America. Integration of medical perspective across therapeutic areas into Global Teams.

• • Maximizes Company’s value proposition of in-line and pipeline products through management and delivery of all medical and scientific activities across TAs

• • Increase medical presence of Company with the medical community

• • Provides leadership and is the key Company spokesperson to external and internal bodies on medical and scientific issues related to Company products

• • Leverages synergies across functions and Therapeutic Areas

• • Guarantees conduct of medical and scientific activities according to all relevant regulations and SOPs

• • Integrates Medical and scientific insight into the North American (USA and Canada), and provides input to global strategies, plans and tactics

• • Actively supports the commercial organization to promote the scientific and medical value of Company products

• • Drives the engagement of KOLs, professional societies and other key stakeholders in North America

• • Plans and is accountable for North America Medical Affairs resources, budget, goals, objectives and performance metrics

• • Manages North America execution of lifecycle management activities

• • Supports local Company sponsored clinical research activities including Investigator Sponsored Studies (ISS’S)

• • Responsible for medical and scientific evaluation and due diligence on Business Development opportunities

• • Supports Local Access and reimbursement activities (communicates medical part of value propositions)

    • • Participates in HQ R&D and HQ Commercial Operations meetings as requiredManages North America safety reporting according to local and international requirements through Safety Manager (x-functionally with Stockholm HQ Pharmacovigilance

  • Ensure global and local requirements are being met by implementing the necessary procedures at affiliate level, including process for reporting, translation and quality control of safety data
  • Ensure appropriate resources are available to manage PV locally, and determine set-up of a PV Hub if dedicated resources are required locally
  • Oversight responsibility of local PV Hub, if available
  • As local contact person for Drug Safety, be contactable 24 hours a day, 7 days a week
  • Act as interface between EU-QPPV and local regulatory authorities as required
  • Secure the integrity and high standards in the handling of adverse events and risk management activities at local level, including for: follow-up locally on adverse events/safety reports, responses to regulatory questions on patient safety matters in national language, implementation of local risk minimization activities
  • Ensure monitoring of local guidance and pharmacovigilance legislation, proposing changes to Drug Safety processes as appropriate to ensure local requirements are being met
  • Ensure that all local potential sources of safety information, including affiliate email inbox, websites, digital and social media forums, and customer relationship management system, are monitored every local business day
  • Ensure that local literature review is performed as per global and local requirements
  • Responsible for the quality of local translations and transfer of safety data from source documents to other medium.
  • Ensure reconciliation of safety data between Sobi affiliate and other internal and external sources
  • Responsible for oversight of any vendor performing PV activities locally
  • Ensure PV related agreements (e.g. contracts with ESP, PSP providers, Market Research providers) include PV clauses.
  • Assist the timely closing of findings related to PV inspection/PV audits at local level
    Position Qualifications (knowledge, skills, abilities, education, experience)

  • Medical Education (MD)
  • >10 years of clinical development and medical affairs experience
  • >10 years’ experience within the pharma or biotech company, both affiliate and global experience desired
  • Broad formal leadership experience
  • Experience in Rare Disease
  • Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions including but not limited to Clinical Operations, Commercial, Regulatory, Safety and Market Access
  • Therapeutic Area knowledge within any of Immunology, Inflammatory diseases (rheumatology), oncology supportive care, and genetics
  • Network of External stakeholders across relevant Therapeutic Areas
  • Knowledge of local pharmaceutical industry and legal/health system environment
  • Finance/budgeting and resource management experience
  • Strong business acumen and an ability to work across geographic boundaries and culturesRole model for others in line with company Values and– strong personal mastery and accountability, engagement, collaborative spirit, and a respectful open working attitude
  • Medical and Scientific excellence
  • Excellent communication and presentation skills
  • Analytical skills and strategic thinking
  • Continuously expanding medical and scientific knowledge as well as market knowledge
  • Broad skill set in Medical Affairs, clinical development, Drug safety and regulatory affairs
  • Strong customer orientation, science based and marketing minded, negotiation skills
  • Ability to effectively, collaboratively and respectfully lead in a matrix and within cross-functional teams