Clinical Operations Director Jobs
Clinical Operations Director jobs are open across pharmaceuticals, medical devices, contract research organizations, and health systems, at levels from associate director to VP, with specializations in clinical trial management, regulatory affairs, and site operations. Find a role that fits from the openings below and apply directly.
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By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role:
The Director, PV Clinical Operations provides functional expertise and program-level oversight of outsourced pharmacovigilance activities across clinical trials, including study setup and conduct, CRO training, and ongoing vendor management. This role involves partnering with stakeholders within and outside PV to ensure globally harmonized operations, consistent application of PV principles and standards, and effective delivery of critical clinical trial safety activities to support Takeda’s mission.
How you will contribute:
- Conduct risk-based quality reviews of outsourced deliverables, including SAE reconciliation, SAE forms and completion guidelines, protocol safety sections, and eTMF documentation.
- Review and provide PV input into key study documents and safety reporting instructions.
- Maintain direct engagement with vendor PV Operations Leads to monitor performance and identify, escalate, and mitigate study and program level risks.
- Represent PV Operations on global program and study teams to ensure appropriate integration of safety requirements.
- Partner with Clinical Science, Data Management, Regulatory Affairs, and other functions to promote consistent PV standards, processes, and regulatory compliance. Lead or support study- and program-specific audits and regulatory inspections.
- Drive continuous improvement in the collection, processing, documentation, and evaluation of clinical trial safety data.
- Maintain current knowledge of global PV regulations and industry practices while mentoring junior team members.
Skills and qualifications:
- Skilled in clinical trial pharmacovigilance operations, providing functional expertise and oversight of outsourced activities.
- Proficient in risk-based quality reviews of clinical trial safety deliverables and documentation.
- Knowledgeable in global PV regulations and industry practices, supporting consistent application of PV standards.
- Skilled in vendor oversight, proactively identifying and addressing operational risks.
- Experienced in supporting audits and regulatory inspections, including preparation of timely responses.
- Strong critical thinking and analytical skills, with the ability to make high-level decisions in cross-functional and global environments.
- Ability to review, analyze, interpret, and present complex data to a high standard. Strong interpersonal communication skills, working effectively with internal and external stakeholders at all levels.
- Good cross-cultural understanding and experience.
- Excellent organizational skills, prioritizing individual and departmental workloads and managing multiple critical issues simultaneously.
- Demonstrated negotiation and consensus decision making skills.
- Able to mentor junior team members and promote cross-functional awareness of PSPV processes and standards.
As a functional expert within Takeda’s global Pharmacovigilance organization, you possess in-depth expertise in clinical trial PV operations and work effectively across related functions. You’re adept at anticipating cross-therapeutic area risks and process gaps, recommending improvements, and developing practical solutions. Your role involves partnering across functions and with CROs to strengthen operational quality, compliance, and integrated ways of working.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Cambridge, MAU.S. Base Salary Range:
$177,000.00 - $278,080.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Cambridge, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob Exempt
Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role:
The Director, PV Clinical Operations provides functional expertise and program-level oversight of outsourced pharmacovigilance activities across clinical trials, including study setup and conduct, CRO training, and ongoing vendor management. This role involves partnering with stakeholders within and outside PV to ensure globally harmonized operations, consistent application of PV principles and standards, and effective delivery of critical clinical trial safety activities to support Takeda’s mission.
How you will contribute:
- Conduct risk-based quality reviews of outsourced deliverables, including SAE reconciliation, SAE forms and completion guidelines, protocol safety sections, and eTMF documentation.
- Review and provide PV input into key study documents and safety reporting instructions.
- Maintain direct engagement with vendor PV Operations Leads to monitor performance and identify, escalate, and mitigate study and program level risks.
- Represent PV Operations on global program and study teams to ensure appropriate integration of safety requirements.
- Partner with Clinical Science, Data Management, Regulatory Affairs, and other functions to promote consistent PV standards, processes, and regulatory compliance. Lead or support study- and program-specific audits and regulatory inspections.
- Drive continuous improvement in the collection, processing, documentation, and evaluation of clinical trial safety data.
- Maintain current knowledge of global PV regulations and industry practices while mentoring junior team members.
Skills and qualifications:
- Skilled in clinical trial pharmacovigilance operations, providing functional expertise and oversight of outsourced activities.
- Proficient in risk-based quality reviews of clinical trial safety deliverables and documentation.
- Knowledgeable in global PV regulations and industry practices, supporting consistent application of PV standards.
- Skilled in vendor oversight, proactively identifying and addressing operational risks.
- Experienced in supporting audits and regulatory inspections, including preparation of timely responses.
- Strong critical thinking and analytical skills, with the ability to make high-level decisions in cross-functional and global environments.
- Ability to review, analyze, interpret, and present complex data to a high standard. Strong interpersonal communication skills, working effectively with internal and external stakeholders at all levels.
- Good cross-cultural understanding and experience.
- Excellent organizational skills, prioritizing individual and departmental workloads and managing multiple critical issues simultaneously.
- Demonstrated negotiation and consensus decision making skills.
- Able to mentor junior team members and promote cross-functional awareness of PSPV processes and standards.
As a functional expert within Takeda’s global Pharmacovigilance organization, you possess in-depth expertise in clinical trial PV operations and work effectively across related functions. You’re adept at anticipating cross-therapeutic area risks and process gaps, recommending improvements, and developing practical solutions. Your role involves partnering across functions and with CROs to strengthen operational quality, compliance, and integrated ways of working.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Cambridge, MAU.S. Base Salary Range:
$177,000.00 - $278,080.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
For information about our benefits, please click here.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Cambridge, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob Exempt
Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Clinical Operations Director Jobs by Experience Level
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Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals10
- Education2
- Medical Devices2
- Science & Research2
- Healthcare & Medical Services2
What Employers Look For
The qualifications that appear most often in clinical operations director jobs.
- Bachelor's or advanced degree in life sciences, nursing, or a related clinical field
- Extensive experience managing Phase I through Phase IV clinical trials end to end
- Deep knowledge of ICH-GCP guidelines, FDA regulations, and applicable international standards
- Proven experience selecting, overseeing, and managing contract research organizations
- Proficiency with electronic data capture systems such as Medidata Rave or Veeva Vault
- Strong cross-functional leadership and budget management experience across global clinical programs
Tips for Your Clinical Operations Director Job Search
Quantify trial oversight on your resume
Clinical operations director candidates who list the number of trials managed, therapeutic areas covered, and team sizes supervised stand out immediately. Hiring managers look for concrete scope, not vague leadership language, so replace phrases like 'oversaw clinical programs' with specific deliverables.
Highlight your ICH-GCP and regulatory fluency
Most job postings require hands-on knowledge of ICH-GCP guidelines, FDA regulations, and at minimum one electronic data capture system. Call these out explicitly in your resume's skills section rather than burying them in job descriptions, where reviewers often miss them.
Target openings by therapeutic area, not just title
Clinical operations directors hired in oncology, rare disease, or CNS trials often need therapy-specific protocol experience. Search by therapeutic area alongside the job title to find openings where your background maps cleanly to what the hiring team actually needs.
Apply early to roles that fit
Migrate Mate lists clinical operations director openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Prepare to discuss budget and vendor management
Interviews at the director level almost always include questions about CRO selection, contract negotiations, and budget oversight. Come ready with a specific example of a vendor relationship you managed, including how you handled performance issues or scope changes mid-trial.
Negotiate start date around study timelines
Clinical operations directors who join mid-study face immediate pressure on deliverables. If you're switching roles, ask where a program stands in its lifecycle before accepting an offer so you can negotiate a start date that gives you adequate onboarding time.
Clinical Operations Director Jobs: Frequently Asked Questions
Which companies are hiring the most clinical operations directors?
The companies hiring the most clinical operations directors right now include Optum, AccentCare, and Revolution Medicines, with the largest share of openings in California, Massachusetts, and New York, based on current listings on Migrate Mate as of November 2026. Demand is concentrated in pharmaceutical companies, contract research organizations, and large health systems running active clinical programs.
How many clinical operations director jobs are remote?
About 61% of clinical operations director openings are fully remote or hybrid as of November 2026, reflecting the role's heavy reliance on digital trial infrastructure and cross-site coordination. Sub-areas like CRO oversight, regulatory operations, and quality management tend to offer the most remote flexibility, while roles tied to a specific research site or hospital system more often require on-site presence.
How do you become a clinical operations director?
Most clinical operations directors start in clinical research coordinator or clinical research associate roles, building direct trial execution experience before moving into project management and then program leadership. Earning credentials such as the ACRP Certified Clinical Research Professional designation strengthens your profile. Progressively managing larger trial portfolios, therapeutic areas, and CRO relationships is the clearest path to the director level.
Can you get hired as a clinical operations director with limited director-level experience?
Yes, candidates who have managed full trial lifecycles as a senior manager or associate director can move into a clinical operations director role, especially at smaller biotech companies or startups with lean leadership teams. Demonstrating that you've owned budget accountability, CRO contracts, and cross-functional team leadership, even without the formal title, is more persuasive to most hiring teams than title alone.
What does the clinical operations director interview process look like?
The process typically opens with an HR or talent acquisition screen focused on background and seniority fit, followed by a panel interview with clinical development leadership, regulatory, and sometimes finance stakeholders. Candidates are usually asked to walk through a complex trial they managed end to end and to address a scenario involving a CRO performance problem or a protocol deviation. A final round may include a brief strategic exercise or executive presentation.
Where can I find and apply to clinical operations director jobs?
You can find and apply to clinical operations director jobs on Migrate Mate, which lists current openings from across the United States. Find roles that fit your background and apply directly to each listing from the same place, without having to track openings across multiple sources.
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