Global Lead – Medical Affairs, Gastroenterology

Working Location: MASSACHUSETTS, WESTBOROUGH; NATIONWIDE; PENNSYLVANIA, CENTER VALLEY 

Workplace Flexibility: Field

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. 

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose: 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

Learn more about Life at Olympus.

• Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

Job Description

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 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: 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.
• Active medical license.
• Deep knowledge of the Gastroenterology therapeutic area and global understanding of medical affairs, clinical evidence development and global healthcare delivery systems.
• Success in product support and ability to bring strategic insight to commercialization plans in respective therapeutic area.
• A track record of executing medical and/or scientific plans in support of product differentiation, addressing healthcare stakeholder needs, and clinical practice patterns on a global level.
• Ability to understand current evolving environmental and market access issues.
• 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.
• Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
• 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.
• Leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive medical, dental, vision coverage effective on start date
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance*
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

• Work-life integrated culture that supports an employee centric mindset
• Offers onsite, hybrid and field work environments
• Paid volunteering and charitable donation/match programs
• Diversity Equity & Inclusion Initiatives including Employee Resource Groups
• Dedicated Training Resources and Learning & Development Programs
• Paid Educational Assistance
• US Only
• Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefit and incentives.

The anticipated base pay range for this full-time position working at this location is $205,189.00 – $328,302.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications. 

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. 

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Applicants with Disabilities:

As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Posting Notes: nearmejobs.eunearmejobs.eu United States (US) nearmejobs.eunearmejobs.eu Massachusetts (US-MA) nearmejobs.eunearmejobs.eu Westborough nearmejobs.eunearmejobs.eu Medical Affairs 

Read Full Description