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Clinical Development Director

Req ID:  182

Working Location: WASHINGTON, REDMOND 

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 Director of Clinical Development reports to the Vice President of Clinical Affairs and will be primarily responsible for the timely development and implementation of clinical development strategy across multiple Olympus Business Units, as well as the interpretation of clinical study results. The Director of Clinical Science will act as a primary driver for Olympus’ clinical development plans and contribute significantly to their operational successes.

Job Duties
Job Duties: :
In a typical day, you will:

* Develop and implement of clinical development plans across Olympus product portfolio.

* Develop coordinated research programs in support of innovative, efficient and adaptable clinical programs suitable for regulatory submission and supporting the clinical value of Olympus Technologies.

* Support the Clinical Operations team by providing clinical guidance toward the design, development, and conduct of clinical trial protocols

* Assist in determining and optimizing subject inclusion/exclusion criteria, and endpoints appropriate to the trials’ customer (patient, prescriber, regulator, payor) oriented objectives

* Select safety and efficacy measures based on available data and guiding selection of appropriate data collection parameters

* Assess  and interpret clinical safety and efficacy data and guiding review and preparation of sections of protocols, clinical study reports, clinical sections of CERs, Core Safety Data Sheets, Investigator Brochures, and other clinical documents

* Interpret and reporting the results of the research, including presentation to: (internal teams; external therapeutic area experts, and customers; global audiences, through publications and lectures)

* Build strong KOL, Principal Investigator and regulator relationships

* Serving as representative to Principle Investigators, Sub-investigators and their site staff ensuring optimal sponsor-site relationships including at Investigator Meetings and clinical site visits

* Participate in the preparation of regulatory filings and responds to regulators’ questions as needed,

* Perform other duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS:

* Master’s in related field required (e.g., Business Administration, Pharmacy Administration, Public Health, Health Services Research, Economics, Epidemiology, Health Policy). PharmD, PhD or MD desirable.

* Minimum of 8 years relevant experience required. 

* Expertise in healthcare industry required. 

* Clinical knowledge across multiple therapeutic areas (traditional and specialty areas), healthcare reimbursement, technical expertise in economic evaluations or patient reported outcomes, preferably including data analysis and statistics required. 

* Experience across multiple research settings (e.g. industry, academia, and/or consulting) required. 

* Experience across various types of data (e.g., administrative claims, electronic health/medical record, hospital billing) is required. 

* Experience interacting with direct managed markets customers via a scientific/medical role or research partnership required. 

* Solid exposure and/or experience in conducting outcomes research studies applying health economics, patient-reported outcomes, retrospective data analyses, epidemiology and/or health services research required. 

* Firm understanding of U.S. health care systems, and established and emerging customers (e.g., ACOs); specifically understanding unique business models, perspectives, and how trends may affect access and other research questions required. 

* Firm understanding of U.S. regulatory standards for approval and communication of data required.

* Ability to work cross-functionally with Sales and Marketing, Physicians-thought leaders, educators, attendees, and customers.

* Ability and willing to travel domestically.

​* Ability to travel up to Up to 60%.

PREFERRED QUALIFICATIONS:

* PharmD, PhD or MD desirable. 

* Ability to build solid relationships and become a trusted and respected partner with colleagues, HCPs, thought leaders.

* Knowledgeable in project management skills.  

* Project manager qualifications are preferred (e.g., CPMP – Certified Project Manager Professional or PMP). 

* Strong cross-functional, interpersonal, prioritization skills.

 * Knowledge of and skill in using Microsoft Office, specifically, Word, Excel, PowerPoint, Project and Outlook. 

 * Ability to challenge the status quo and champions new initiatives.  

* Act as a catalyst for change, engages others, and manages implementation effectively. 

* Ability to build consensus, support colleagues, set a tone of collaboration within teams, resolve issues among Associates. 

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.

 

Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.  EOE Minorities/Females/Veterans/Disabled

 

Posting Notes: || United States (US) || Washington (US-WA) || Redmond || 

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