Top Government Affairs Executive (State Level) jobs in Worcester, MA

Job Description

The Executive Director of Medical Affairs, for Gastroenterology – Endotherapy (GIET) is a qualified gastrointestinal endoscopist that is part of Medical and Scientific Affairs (MSA) and reports directly to the Chief Medical Safety Officer. This position is responsible for shaping the global GIET Therapeutic Area (TA) strategy, product portfolio and contributing to clinical development programs. As a physician this role requires applying clinical knowledge and medical training to lead peer-to-peer scientific engagements with physicians, payors, professional societies, patient advocacy groups, and health system leaders. The Executive Director will be responsible for leading in a highly matrixed internal business environment to drive medical innovation, identifying clinical insights, unmet needs, informing strategy, and validating the value propositions for Olympus’ products in the GIET therapeutic area.

Job Duties

• Plan, manage and execute medical strategy through internal and external stakeholder engagement, while providing systematic and valid clinical evidence input to ensure that the strategy is clearly defined and consistent with business objectives.
• Conceives, develops, and implements strategies to support Olympus’ strategic and financial goals by building productive professional relationships with the medical community to identify unmet patient and health care provider needs and promising business opportunities involving emerging medical and health care practices.
• Gives medical/scientific input into Business Development, R&D, marketing, and Therapeutic Solutions Division (TSD) strategies, based on her/his medical expertise, and guides teams to understand what is medically important in product design, development, and lifecycle management.
• Provides global medical leadership to drive alignment to the GIET medical strategy across all phases of product development, and include all activities (insights, unmet needs, preclinical and clinical research, investigator-initiated studies, registries, real world evidence, market access, professional education), to ensure launch excellence.
• Supports the development and execution of the GIET evidence generation and dissemination strategy, providing expert input pertaining to the unmet clinical need and overall value proposition. Additionally, provides critical input for the selection of appropriate clinical platform and scientific communication plan.
• Develops and manages the medical affairs operating plan for the GIET TA.
• Contributes to and develops the GIET TA Medical Affairs strategy and drives harmonization globally while accommodating for differences in regional implementation.
• Engages with cross-functional team members in Clinical Affairs, Operations Center of Excellence, Professional Affairs, Health Economics and Market Access, R&D, Regulatory, and Medical Safety and Infection Prevention & Control to review clinical evidence and to evaluate a product’s risk-benefit calculus.
• Serves as a medical Subject Matter Expert (SME) expert within Olympus, as needed (e.g., ad hoc review of promotional materials, contribute to development/adaptation of medical materials, such as CERs, presentations, trainings, medical briefs and talking points).
• The Medical Director, GIET is responsible for contributing to the MSA mission and objectives, and strategy over a 3- to 5-year time horizon and is accountable to the Chief Medical Safety Officer.
• Develops and works to continually improve Medical Affairs’ infra-structure, including development of SOPs, best practices, and training and workshops.
• Provides leadership, career development, coaching and mentoring to direct and indirect reports as well as developing a succession plan, in the future.
• Supports Medical Safety function in risk management and design controls.
• Other duties as assigned.

Job Qualifications

Required:

• Medical Doctor (MD), or non-US equivalent of MD with independent clinical practice experience
• Board Certification (Gastroenterology – American Board of Internal Medicine)
• Advanced Endoscopy Fellowship (AEF) in Interventional Gastroenterology
• Active State Medical License (any of the 50 states)
• Minimum of 10-12 years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in all phases for development projects and regulatory space or combination of relevant clinical practice, training, and education.
• Demonstrated deep knowledge of the therapeutic area and global understanding of medical affairs, clinical evidence development and global healthcare delivery systems.
• Demonstrated success in product support and ability to bring strategic insight to commercialization plans in respective therapeutic area.
• Demonstrated track record of executing medical and/or scientific plans in support of product differentiation, addressing healthcare stakeholder needs, and clinical practice patterns on a global level.
• Demonstrated ability to understand current evolving environmental and market access issues.
• Demonstrated success working in a matrixed organization, partnering with multiple internal & external stakeholders to deliver against the business unit strategy.
• Vitality and scheduling flexibility to commit to a global schedule navigating multiple time zones with extended hours into the early morning as well as late evenings (e.g., Eastern Standard Time: UTC-5, Central European Time: UTC 1, and Japan Standard Time: UTC 9)
• Domestic and international travel 25%, including weekend and evening travel as needed.

Preferred:

• Strong knowledge and application of ICH GCP, ISO 14155, global regulations and good document management practices preferred.
• Ability to think strategically, critically assess and synthesize complicated data and scientific information.
• Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
• Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.
• Demonstrated leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.
• Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.

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