Executive Director, Global Lead, Digital Unit

Job Description

The Executive Digital Unit Medical Director (DUMD) is a physician/surgeon with deep clinical practice knowledge, medical affairs industry experience, and/or digital health competencies and management proficiencies to effectively deliver medical guidance to Olympus Digital Unit (DU). Three fundamental areas of competencies for this role include: 1.) Provide comprehensive medical affairs and clinical research programs from strategy to execution to substantiate medical/clinical claims, 2.) Support health economics / market access value analysis through clinical outcomes research, and 3.) Advise and collaborate on the effective medical integration of current and future digital health technologies/therapeutics into a cohesive overarching digital ecosystem (artificial intelligence, image analysis, medical informatics, software enabled robotic solutions, clinical decision support tools, and patient engagement/experience) to improve equitable access to care and functional clinical outcomes. The DUMD is part of the growing organization of medical directors within Medical and Scientific Affairs (MSA). The intended purpose of the DUMD is to be an embedded point of contact taking ownership for delivering a wider portfolio of MSA assets into the DU operational processes. The DUMD role requires the application of prior clinical knowledge and medical training to lead internal stakeholders within the DU while simultaneously demonstrating proficiencies in external scientific engagement via peer-to-peer consultations with physicians, payors, professional societies, patient advocacy groups, as well as health system and integrated delivery networks. The successful candidate will bring a combination of strategic mindset, strong operational involvement (hands on mentality), and servant leadership with the profound ability to influence across these highly matrixed internal and external environments.

Job Duties

• 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.
• Medical Affairs: The DUMD is an applied medicine subject matter expert within the DU responsible for the provisioning of medical practice insights, intended use, and anticipated clinical impact. This spans the product lifecycle through all phases of product development (Initial Conceptualization à Product Development à Launch Excellenceà Lifecycle Management) and will include internal as well as external scientific HCP (peer-to-peer) as well as societal engagement.
• 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 DU 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 DUs 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 DU 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 DU and other MSA subfunctions not previously identified above (i.e., strategy and operations, grants, biostatistics, program management, professional affairs, physician consulting and contract management).

Job Qualifications

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 level.

Preferred:

• Chief Medical Informatics Officer (CMIO) experience preferred.
• Current medical license and actively participating in Maintenance of Certification (MOC)
• Therapeutic area focus (Gastroenterology, Urology, Pulmonary, General Surgery)
• Additional advanced degrees: PhD, MS, MBA, or MPH desired
• Board Certification (American Board of Medical Specialties or equivalent)
• Independent medical practice experience as an individual health care provider
• Demonstrated ability to understand current economic environment and market access issues.
• Confirmed success working in a matrixed organization, partnering with multiple internal & external stakeholders to deliver against the business unit strategy.
• Ability to think strategically, critically assess and synthesize complicated data and scientific information. 
• Persuasive consulting, facilitation, and communication skills bridging between medical/scientific and business priorities, to manage effective international and cross-divisional collaboration. 
• 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.