Global Executive Digital Unit Medical Director

vor 5 Monaten

Hamburg, Deutschland Olympus Europa SE & Co. KG (OEKG) Vollzeit

**Responsibilities**:

- Digital Medical Strategy: Provide expert medical and clinical insights to inform the effective development of the digital medical strategy through internal and external engagements while providing continuous input to ensure that the strategy remains clearly defined and consistent with business objectives
- Clinical Research: Conceive, develop, and implement the most appropriate global clinical research strategy, study design, and operational execution of industry sponsored clinical investigations (guidance, site selection, contracting, investigator training, IRB submissions, enrollment case monitoring & reporting, safety monitoring, risk management, closure, summation for publication, and best practice sharing)
- Clinical Evaluation: 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
- Clinical Integration: Demonstrate proficiencies in developing an integrated, global clinical evidence strategy which may span the range of traditional industry sponsored trials, request directed investigator-initiated studies, industry sponsored registries, real world evidence, insurance (payor) databases, as well as societal research, registries, and global study groups
- HEMA/HEOR: Support health economic outcomes research for market access (coverage, coding, reimbursement) by aligning MSA HEMA resources to meet Digital Unit needs
- Therapeutic Area Expertise: Support the digital health strategic goals by providing critical insights obtained through productive peer to peer physician relationships within the following therapeutic areas: Gastroenterology, Urology, Pulmonary, General Surgery, Otolaryngology, Obstetrics/Gynecology, Neurological Surgery and Orthopedic Surgery
- Scientific Platform: 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)
- MSA Strategy: The DUMD is responsible for advocating the Digital Unit's 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
- Medical Safety: Engage with cross-functional team members in Medical Safety and Infection Prevention Control to provide Digital Unit expertise pertaining to risk management, design controls, health hazard assessments, complaints assessment, CAPAs, nonconformances, and benefit risk determinations
- MSA Subfunctions: Serve as a liaison between the Digital Unit and other MSA subfunctions not previously identified above (i.e., strategy and operations, grants, biostatistics, program management, professional affairs, physician consulting and contract management)

Your qualification

Required:
- Medical Doctor (MD), or equivalent (DO, MBBS) graduate from an accredited medical institution
- Practice experience in digital medical technologies and therapeutics
- 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
- 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
- Vitality and scheduling flexibility to commit to a global weekly schedule (Tuesday - Wednesday - Thursday) 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 - 40%, including weekend and evening travel as needed
- Demonstrated deep knowledge of the therapeutic area and global understanding of medical affairs, clinical evidence development and global healthcare delivery systems
- Exhibited success in MedTech product development and ability to bring strategic insights to commercialization plans in the digital therapeutics area
- Proven history of executing medical and/or scientific plans in support of product differentiation, addressing healthcare stakeholder needs, and clinical practice patterns on a global levelPreferred:
- Chief Medical Informatics Officer (CMIO) experience preferred
- Current medical license and actively participating in Maintenance of Certification (MOC)
- Therapeutic a

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