Global Lead - Medical Affairs, Gastroenterology

Working Location:
Remote

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The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified, fellowship trained gastroenterologist proficient in endoscopy with deep clinical practice knowledge, medical affairs industry experience, and/or health leadership competencies and management proficiencies to effectively deliver expert medical guidance to the Gastroenterology business. Fundamental competencies for this role include:
1. ) Gastroenterology disease state, procedural, clinical, and technological market knowledge & experience, 2. ) Comprehensive medical affairs proficiencies (e. g. , practice insights, care delivery, intended use, clinical impact, and intended therapeutic benefit) spanning from ideation to execution across the product lifecycle, 3. ) Capabilities in clinical integration of current and future gastroenterology diagnostic/therapeutic technologies to improve equitable access to care while delivering meaningful clinical and economic outcomes. The GLMAG is part of the growing Medical Affairs division within the broader Medical and Scientific Affairs (MSA) of Olympus. The intended purpose of this role is to support the Gastroenterology global leadership team as an applied medicine expert for medical strategy development and to champion the patient and provider prospective. This role requires the application of prior clinical knowledge and medical training to lead internal stakeholders within the Gastroenterology therapeutic area 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 worldwide. The successful candidate will bring a combination of strategic mindset, strong operational involvement ('hands on mentality'), together with a personality of being a team player, humble and inquisitive, along with servant leadership skills and the ability to influence across matrixed internal & external environments.

Job Duties

Medical Strategy:
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. Medical Affairs:
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 (Initial Conceptualization, Product Development, Launch Excellence, Lifecycle Management) and will include internal as well as external scientific HCP (peer-to-peer) as well as societal engagement.

Clinical Research:
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). Clinical Evaluation:
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.

Clinical Care Integration:
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.

HEMA/HEOR:
The GLMAG will support health economic outcomes research for market access (coverage, coding, reimbursement) by aligning MSA HEMA resources in the most appropriately manner.

Therapeutic Area Expertise:
Support the Gastroenterology business strategic goals by providing critical insights obtained through productive peer to peer physician and societal scientific engagements.

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:
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.

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.

GI Leadership Team:
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.

Job Qualifications

Required:


Medical Doctor (MD) degree, with demonstrated independent clinical practice experience Gastroenterology Fellowship Trained Board Certification.

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.

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).

Other Considerations (travel/hours availability, etc. ):
Domestic and international travel 40-50%, including weekend and evening travel as needed.

Preferred:


Additional advanced degrees:
PhD, MS, MBA, or MPH desired.

Active participation in a Maintenance of Certification (MOC) program.