Global Lead, Medical Affairs, GIET

Job Description

The Global Lead Medical Affairs, Gastroenterology EndoTherapy (GLMAGIET) is a board-certified, advanced fellowship trained gastroenterologist proficient in therapeutic 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 EndoTherapy business. 

The GLMAGIET 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 EndoTherapy 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 EndoTherapy 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 EndoTherapy 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 GLMAGIET is an applied medicine subject matter expert within the Gastroenterology EndoTherapy 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 Health Care Professionals (peer-to-peer) as well as societal engagement.  Most critically, the GLMAGIET supports both Research & Development for organic product development and Business Development for inorganic product development.
• Clinical Affairs: To support the Global Head of Clinical Research 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 GLMAGIET 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, and patient-centric. 
• HEMA: The GLMAGIET will support Health Economics outcomes research for Market Access (coverage, coding, reimbursement) by aligning MSA HEMA resources in the most appropriate manner. 
• Therapeutic Area Expertise: Support the Gastroenterology EndoTherapy business strategic goals by providing critical insights obtained through productive peer to peer physician and societal scientific engagements. 
• Scientific Affairs: 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 EndoTherapy business’ unique needs to be incorporated into the MSA strategy as well as operationally through infra-structure advancements, Standard Operating Procedures (SOPs), best practices, trainings, and work instructions (WIs) over a 3–5-year time horizon. 
• Medical Safety: Engage with cross-functional team members in Medical Safety and Infection Prevention Control to provide expertise pertaining to risk management, design controls, health hazard assessments, human factors engineering, complaints assessment, CAPAs, nonconformances, and benefit risk determinations.
• Domestic and international travel up to 40%, including weekend and evening travel as needed.

Job Qualifications

Required:

• Medical Doctor (MD) degree, or non-US equivalent of an MD with demonstrated independent clinical practice experience in Gastroenterology EndoTherapy
• Minimum of 5 years of MedTech medical device/biotechnology/pharmaceutical 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 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)
• Board Certification (Gastroenterology)
• Advanced Endoscopy Fellowship (Interventional Gastroenterology)
• Active Medical License
• Proficiency in performing:
  • • Endoscopic Retrograde Cholangiopancreatography (ERCP)
    • Endoscopic Ultrasound (EUS) with Fine-Needle Aspiration/Biopsy (FNA/FNB)
    • Endoscopic Submucosal Dissection (ESD)
    • Peroral Endoscopic Myotomy (POEM) and related third space procedures (G-POEM)

Preferred:

• Additional advanced degrees: PhD, MS, MBA, or MPH desired
• Active participation in a Maintenance of Certification (MOC) program