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Global Clinical Lead, Respiratory

Olympus Medical Systems

Olympus Medical Systems

Westborough, MA, USA
Posted on Wednesday, June 26, 2024

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.

**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 of Respiratory Clinical Affairs reports directly to the Global Head of Clinical Research and collaborates closely with the leadership of Clinical Affairs to lead clinical strategy activities and oversee all aspects of clinical studies in support of clinical evidence generation strategies across the Respiratory business unit portfolios.

The individual is a critical member of Clinical Affairs leadership team and collaborates with cross-functional teams including internal and external business stakeholders within MSA, across the Respiratory business unit, and within the broader Olympus organization, as appropriate.

Job Duties

  • In collaboration with internal and external to MSA stakeholders, contribute to a evidence generation strategy that will drive the clinical evidence strategy for the Respiratory business unit.
  • Oversees all aspects of Clinical Study Management within the Respiratory business unit.
  • Clinical Study Management includes all activities mandated by 21 CFR 812 or EU-MDR and GCP (ISO-14155:2020) and related to enrolling and following subjects in a clinical study at research sites including documented evidence of compliance.
  • Provides critical input into Business Development, R&D, and Respiratory business unit product development project (PDP) activities to inform decision-making on whether clinical evidence supports a product’s value proposition. In situations entailing substantial clinical risk, they propose reasonable mitigation strategies, which may involve future clinical studies.
  • Participates in strategic and operating planning activities in partnership with the Global Head of Clinical Affairs, in translating corporate and divisional initiatives into operational plans.
  • Develops an outsourcing strategy as required to employ Contract Research Organizations (CROs), or other external vendors, in clinical studies and ensures management and oversight of the vendor(s).
  • Establishes and oversees activities to ensure regulatory compliance across all project teams by establishing clinical research best practices, which are supported by quality procedural documents, standards, and tools.
  • Ensures clinical studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
  • As a member of the Clinical Affairs leadership team, takes ownership of the Clinical Affairs mission, objectives, and strategy over a 3- to 5-year time horizon, and is accountable to the Global Head of Clinical Affairs.
  • Develops and works to continually improve Clinical Affairs’ infrastructure, including development of SOPs, best practices, and training and workshops.
  • Provides leadership, career development, coaching and mentoring to direct reports as well as developing a succession plan.
  • Other duties as assigned.

Job Qualifications

Required:

  • BA/BS degree in life sciences or related field.
  • Minimum of 15 years device/pharmaceutical industry experience preferably in Clinical Affairs/Operations, Medical Affairs within pharma/biotech industry (preferably in multiple phases and multiple roles).
  • Experience in overseeing clinical operations’ procedural documentation requiring a strong knowledge and application of global regulations, guidelines and standards (i.e., ICH E6 (R2), EU MDR, ISO 14155:2020) and good document management practices.
  • 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.
  • Domestic and international travel up to 10%, including weekend and evening travel as needed to support business objectives and ongoing development of physician relationships.
  • 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.


Preferred:

  • MA/MS or PhD degree in life sciences or related field
  • Relevant professional certification (i.e., CCRC, CCRA, CCRP, PMP)
  • Direct people management experience and managing teams.
  • Strong budget and forecasting expertise.
  • Experience working on respiratory studies and programs.
  • Ability to think strategically, critically analyse 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.
  • 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.

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

  • Competitive salaries, annual bonus and 401(k)* with company match
  • Comprehensive Medical, Dental, Visions coverage effective on start date
  • 24/7 Employee Assistance Program
  • Free virtual live and on-demand wellness classes
  • Work-life balance supportive culture with hybrid and remote roles
  • 12 Paid Holidays
  • Educational Assistance
  • Parental Leave and Adoption Assistance
  • Volunteering and charitable donation match programs
  • Diversity & Inclusion Programs including Colleague Affinity Networks
  • On-Site Child Daycare, Café, Fitness Center**

*US Only

**Limited locations

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position working at this location is $147,763.00 - $206,869.00 / 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.

About us:

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

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: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs