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Vice President Medical Affairs
Clinical Dynamix, Inc.
Job Location: Waltham, MA
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 Companys 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 (ISSS)

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

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