Therapeutic Area Head (Director) - Clinical Operations
Therapeutic Area Head (Director) - Clinical Operations
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Job Description
Job Description
As the Therapy Area Head you will play a pivotal role in overseeing the performance of our clinical trials across multiple therapeutic areas. This is your opportunity to lead a dynamic team and make a significant impact on our clinical research portfolio.
Youll have oversight of the clinical trials across multiple therapeutic areas managing a portfolio of studies from feasibility through to close-out. You will lead a team of Clinical Research Managers to ensure exceptional study performance whilst adhering to local regulations Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines. You will play an integral role in our UK&I Leadership team and be instrumental in nurturing talent fostering a robust pipeline of future leaders. Youll collaborate closely with local stakeholders such as Global Medical Affairs (GMA) Global Health and Human Services (GHH) Pharmacovigilance (PV) and regulatory bodies to drive alignment and enhance the capabilities of our clinical research landscape.
What You Will Do:
Oversee our therapeutic areas within our growing clinical trial portfolio ensuring successful execution and quality.
Ensure timelines and key milestones are met while maintaining high standards of quality and compliance with local regulations and ICH GCP.
Create operational strategies and quality plans for the conduct of all programs and studies in your therapeutic area.
Provide oversight and line management for the Clinical Research Manager (CRM) team fostering talent development and retention.
Work closely with local and regional stakeholders to build relationships with principal investigators and sites.
Contribute to strategic initiatives across Global Clinical Development and support local strategy development aligned with corporate needs.
Together with your team ensure the effective conduct of clinical studies while maintaining regulatory requirements.
Directly influence the our ability to achieve business targets and foster productive collaborations with internal and external partners.
What you will need:
Significant experience within a pharmaceutical clinical trial organization in a functional management position.
CRA project management and CRM experience
Line management experience
Bachelors degree in Science or equivalent healthcare experience
We are proud to be a company that embraces the value of bringing diverse talented and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively. We are an equal opportunity employer committed to fostering an inclusive and diverse workplace.
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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Adaptability Adaptability Business Clinical Development Clinical Research Clinical Risk Management Clinical Site Management Clinical Testing Clinical Trial Documentation Clinical Trial Management Clinical Trial Planning Clinical Trials Operations Decision Making Emotional Intelligence Ethical Standards Good Clinical Practice (GCP) ICH GCP Guidelines Management Process Medical Affairs Multiple Therapeutic Areas People Leadership Pharmacovigilance Plan of Action and Milestones (POA&M) Process Improvements Professional Networking 4 morePreferred Skills:
Job Posting End Date:
06/26/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
