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Global Head, Clinical Affairs

Req ID:  1688

Working Location: PENNSYLVANIA, CENTER VALLEY 

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. 
 
Let’s inspire healthier lives, together.

Job Description

The Global Head of Clinical Affairs reports directly to the Global Head of Medical and Clinical Affairs (MCA) and collaborates closely with the leadership of the two other functions within MCA – Medical Affairs and Operations Center of Excellence – to run all aspects of clinical studies in support of clinical evidence generation strategies across the Endoscopic Solutions Division (ESD)/Therapeutic Solutions Division (TSD) business unit portfolios. 
The individual is a critical member of MCA leadership and collaborates with cross-functional teams including internal and external business stakeholders within MSA, across ESD and TSD business units, and within the broader Olympus organization, as appropriate. 

Job Duties

* In collaboration with the Global Head and Global Leads of Medical Affairs, the Global Head of Operations Center of Excellence, and the Global Head of Health Economics & Market Access, conceives, develops, and implements clinical study strategies to support ESD and TSD product development programs.

 

* Responsible for all aspects of Trial Management, Data Analysis and Reporting (with Operations Center of Excellence), and Sustaining Activities.

 

* Provides critical input into Business Development, R&D, and ESD/TSD Product Development Project activities to inform decision-making on whether clinical evidence supports a product’s value proposition. In situations entailing substantial clinical risk, advances reasonable mitigation strategies, which may involve future clinical studies.  
 

* Participates in strategic and operating planning activities in partnership with the Global Head of MCA, Global Head of Medical Affairs, and the Global Head of Operations Clinical Center of Excellence in translating corporate and divisional initiatives into operational plans.
 

* Develops an outsourcing strategy 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 MCA leadership team, takes ownership of the MCA mission, objectives, and strategy over a 3- to 5-year time horizon, and is accountable to the Global Head of MCA.
 

* Develops and works to continually improve Clinical Affairs’ infra-structure, 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.
 

Job Requirements

REQURIED QUALIFICATIONS:

 

* Master's degree is required.

 

* Minimum 10 years of biotechnology/pharmaceutical/medical device industry experience preferably in Clinical Affairs/Operations, Medical Affairs within pharma/biotech industry (preferably in multiple phases and multiple roles); and a minimum of 5 years in progressive medical affairs, clinical operations leadership roles. 

 

* Domestic and international travel 40%, including weekend and evening travel as needed.

 

PREFERRED QUALIFICATIONS:

 

* PhD degree in life sciences or related field.

 

Prior experience in establishing and managing a strategic Clinical Affairs/Operations organization. 
 

* Direct people management experience and managing teams.
 

* Budget and forecasting experience.
 

* 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.
 

* Experience in overseeing clinical operations’ procedural documentation requiring a strong knowledge and application of global regulations, guidelines, and standards (i.e., ICH E6 (R2), ISO 14155:2020) and good document management practices. 
 

* 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. 
 

* 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. 
 

* Demonstrated leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ 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 overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.

Olympus…True To You. True To Society. True To LIFE.

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.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || 

 

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