Executive Director, Global Lead - Endoscopic Solutions Ecosystem

Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY 

Workplace Flexibility: Field

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Endoscopic Solutions Ecosystem Medical Director (ESE) is a physician/surgeon with deep clinical practice knowledge, medical affairs industry experience, and/or endoscopic competencies and management proficiencies to effectively deliver medical guidance to Olympus Endoscopic Solutions Ecosystem (ESE). 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 Endoscopic Solutions Ecosystem integration of current and future endoscopic health technologies/therapeutics into a cohesive overarching Endoscopic Solutions 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 ESEMD is part of the growing organization of medical directors within Medical and Scientific Affairs (MSA). The intended purpose of the ESEMD is to be an embedded point of contact taking ownership for delivering a wider portfolio of MSA assets into the ESE operational processes. The ESEMD role requires the application of prior clinical knowledge and medical training to lead internal stakeholders within the ESE 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

• Endoscopic Solutions Ecosystem Strategy: Provide expert medical and clinical insights to inform the effective development of the endoscopic solutions overarching strategy across the ecosystem 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 ESE MDis is an applied medicine subject matter expert within the ESE 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: Support the Clinical Research Team in their ability to 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.