Global Lead, Medical Affairs, Gastroenterology in Hamburg bei Olympus Europa SE & Co KG (OEKG)

Your responsibilities

• Provide expert medical and clinical insights to inform the effective development of the Gastroenterology medical strategy through internal and external engagements while providing continuous input to ensure that the strategy remains clearly defined and consistent with business objectives
• This GLMAG is an applied medicine subject matter expert within the Gastroenterology therapeutic area responsible for providing medical practice insights, intended use, and anticipated clinical impact. This spans the product lifecycle through all phases of product development and will include internal as well as external scientific HCP (peer-to-peer) as well as societal engagement
• To support the Global Head of Clinical Affairs in the conception, development, and implementation of impactful clinical investigations to arrive at relevant study designs by providing applied medicine therapeutic expertise to the clinical team (e.g., practice insights, care delivery, clinical impact assessments, and intended therapeutic benefit)
• The GLMAG will support the Clinical Evaluation team through consultations on literature search strategy, data appraisal, threshold of performance, and assessment of clinical benefits. Contributing authorship of Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER), Summary of Safety & Clinical Performance (SSCP) and Periodic Safety Update Report (PSUR) is expected as well as providing input on equivalent comparators, state of the art, to substantiate safety and performance
• Demonstrate proficiencies in understanding and facilitating the coordination of patient care, (including care redesign), across conditions, providers, settings, and time to achieve care that is safe, timely, effective, efficient, equitable, and patient-centric
• The GLMAG will support health economic outcomes research for market access (coverage, coding, reimbursement) by aligning MSA HEMA resources in the most appropriately manner
• Support the Gastroenterology business strategic goals by providing critical insights obtained through productive peer to peer physician and societal scientific engagements
• Provide critical input for the patient care pathway, as well as the Scientific Communication Strategy and Publication Strategy. Responsibilities also include supporting responses to Medical Information Requests (MIRs)
• Responsible for advocating the Gastroenterology business’ unique needs to be incorporated into the MSA strategy as well as operationally through infra-structure advancements, SOPs, best practices, trainings, and work instructions over a 3–5-year time horizon
• Engage with cross-functional team members in Medical Safety and Infection Prevention Control to provide DU expertise pertaining to risk management, design controls, health hazard assessments, complaints assessment, CAPAs, nonconformances, and benefit risk determinations
• Serve as a member of the GI Business leadership team to provide input on state of the art within the therapeutic space as well as medical affairs strategy for scientific engagement. Support to the Medical & Scientific Affairs subfunctions in their interactions with the Gastroenterology global team is expected
• Collaborate effectively with the growing community of partners including Legal, Finance, Data Privacy, Product Security, IT-Cybersecurity, Intellectual Property, HR, Health Care Compliance, Procurement, and Supply Chain
• Fulfil the role as the medical expert within the Gastroenterology business to provide clinical practice insights to support and assist the team responsible for the review of promotional materials. When necessary incorporate new medical insights to adapt and evolve these materials to regional and global ever changing practice patterns
• Provide medical/scientific input into Business Development, R&D, marketing, and greater Gastroenterology business strategies, based on their knowledge and medical expertise. Guide teams to understand what is medically important in digital product design, development, and lifecycle management. Provide integration strategy and operational implementation guidance for acquisitions

Your qualification

• Medical Doctor (MD) degree, with demonstrated independent clinical practice experience
• Gastroenterology Fellowship Trained
• Board Certification
• Additional advanced degrees: PhD, MS, MBA, or MPH desired
• Active participation in a Maintenance of Certification (MOC) program
• Active medical license
• 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
• Dee