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Global Head, Clinical Operations / Biometrics & Data Management

Req ID:  1689

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 Operations Center of Excellence 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 Clinical Affairs – 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 of MCA, Global Head and Global Leads of Medical Affairs, the Global Head and Global Leads of Clinical Affairs, 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 clinical study Data Analysis and Reporting with Clinical Affairs mandated by 21 CFR 812 and GCP.

 

* Manage the Clinical Evaluation Report (CER) function, in collaboration with Global Medical Affairs, to develop and maintain CERs and CER-related regulatory compliance documents.

 

* Manage the Biometrics & Data Management function, which is responsible for statistical analyses and programming for clinical studies and research projects, developing statistical analysis plans, and assist in study design and data management review and consultation.

 

* Manage the Payments and Contracts function, which is responsible for negotiating, maintaining, updating, and auditing commercial contracts in compliance with Olympus policies, procedures, regional and local requirements, and global guidelines and standards.

 

* Provide 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 associated with substantial clinical risk, advances reasonable mitigation strategies, which may involve the design of additional clinical studies.  

 

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

 

* Establish and oversee activities to ensure regulatory compliance across all project teams by establishing clinical research and regulatory best practices, which are supported by quality procedural documents, standards, and tools.
 

* 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.
 

* Establish MCA global business processes, aligned with MSA cross-functional business processes; establish functional process owners supporting the lifecycle management of the MCA quality documents,
   

* Partner with MSASO PMO, IT business partners, and relevant stakeholders to complete system gap analyses; establish and maintain an MCA technology roadmap; oversee functional implementation of  system and tool enhancements.
 

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Master's degree is required.

 

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

 

* Domestic and international travel 20%, including weekend and evening travel as needed.

 

PREFERRED QUALIFICATIONS:

 

* 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.

 

* Demonstrated success working in a matrixed organization, partnering with multiple internal & external stakeholders to deliver against the business unit strategy.

 

* 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.

 

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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