Clinical Director Jobs in Cambridge, MA
Clinical Director jobs in Cambridge are in strong demand, concentrated in Kendall Square, East Cambridge, and the Harvard Square corridor across academic medical centers, biotech, and behavioral health. Employers hiring right now include Takeda Pharmaceuticals, Bristol Myers Squibb, and BioNTech. Scan the live roles below and apply to whichever ones fit.
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Scholar Rock is seeking an experienced and motivated Senior Director, Head of Clinical Quality Assurance to provide strategic and operational leadership for Good Clinical Practice (GCP) quality across the company’s biologics clinical development portfolio. Reporting to the Head of Global Quality, this role will serve as the senior Clinical QA leader and trusted partner to Clinical Operations, Clinical Development, Regulatory Affairs, Pharmacovigilance, Biometrics, Data Management, and external clinical service providers. The position is accountable for clinical quality strategy, GCP quality systems, clinical quality risk management, CRO and vendor oversight, audit strategy, inspection readiness, quality metrics, and the maturation of fit-for-purpose processes that embed quality by design across the clinical trial lifecycle.
Position Responsibilities:
- Lead the Clinical Quality Assurance function, providing strategic direction and operational oversight for GCP quality across Scholar Rock-sponsored clinical trials, with a focus on biologics development programs.
- Serve as the senior GCP Quality partner to Clinical Operations, Clinical Development, Regulatory Affairs, Pharmacovigilance, Biometrics, Data Management, and other cross-functional stakeholders.
- Define, implement, and continuously mature the clinical quality strategy, governance model, and GCP quality management processes aligned with global regulatory expectations and clinical development priorities.
- Provide quality oversight for global clinical trials, including protocol compliance, informed consent processes, investigator site oversight, trial master file quality, data integrity, safety reporting interfaces, and clinical study documentation.
- Establish and execute a risk-based GCP audit program, including audits of investigator sites, CROs, vendors, clinical systems, TMF processes, and key internal clinical trial activities.
- Lead GCP inspection readiness activities and support preparation, conduct, response development, and follow-up for FDA, EMA, PMDA, and other health authority inspections.
- Provide oversight of GCP deviations, serious breaches, audit observations, inspection findings, CAPAs, and quality issues to ensure timely investigation, appropriate root cause analysis, effective corrective actions, and sustainable remediation.
- Oversee CRO and clinical vendor quality governance, including qualification, risk assessment, quality agreements where applicable, performance metrics, issue escalation, and continuous improvement.
- Partner with clinical and regulatory teams to proactively identify and mitigate quality risks associated with study design, trial execution, vendor performance, data integrity, patient safety, protocol deviations, and submission readiness.
- Develop and monitor GCP quality metrics, dashboards, and trend reports to support proactive risk management, governance discussions, and executive-level quality visibility.
- Author, review, and approve GCP-related SOPs, policies, quality plans, audit reports, CAPA plans, inspection materials, and other controlled documents as appropriate.
- Build, lead, and develop a fit-for-purpose Clinical QA function appropriate for a fast-paced, outsourced biotech operating model.
- Champion a culture of quality, accountability, patient safety, data integrity, transparency, and continuous improvement across internal teams and external partners.
Candidate Requirements:
- BS/MS degree in a scientific, healthcare, or related discipline; advanced degree preferred.
- 15+ years of experience in the pharmaceutical/biotech industry, including significant experience in Clinical Quality Assurance, Clinical Operations, clinical development, or related GCP compliance roles.
- 10+ years of hands-on GCP quality experience, including leadership of global clinical quality programs and oversight of Phase I–III clinical trials.
- Deep knowledge of ICH-GCP, ICH E6(R3), FDA, EMA, PMDA, and other global clinical trial regulations and expectations.
- Experience supporting biologics clinical development programs; late-stage development, registration-enabling studies, and inspection readiness experience strongly preferred.
- Demonstrated experience leading or supporting regulatory inspections, including inspection preparation, hosting, response development, CAPA management, and follow-up commitments.
- Strong experience with CRO and clinical vendor oversight, investigator site audits, TMF quality, clinical systems, data integrity, risk-based quality management, and quality issue escalation.
- Proven ability to design and mature fit-for-purpose GCP quality systems, SOPs, audit programs, quality metrics, governance forums, and inspection readiness frameworks in an outsourced biotech model.
- Strong judgment, executive presence, technical writing capability, and the ability to influence cross-functional leaders and external partners.
- Highly proactive, decisive, and capable of balancing strategic leadership with hands-on execution in a fast-paced environment.
- Engaged leader committed to building culture, mentoring talent, and developing scalable Clinical QA capabilities.
Scholar Rock is seeking an experienced and motivated Senior Director, Head of Clinical Quality Assurance to provide strategic and operational leadership for Good Clinical Practice (GCP) quality across the company’s biologics clinical development portfolio. Reporting to the Head of Global Quality, this role will serve as the senior Clinical QA leader and trusted partner to Clinical Operations, Clinical Development, Regulatory Affairs, Pharmacovigilance, Biometrics, Data Management, and external clinical service providers. The position is accountable for clinical quality strategy, GCP quality systems, clinical quality risk management, CRO and vendor oversight, audit strategy, inspection readiness, quality metrics, and the maturation of fit-for-purpose processes that embed quality by design across the clinical trial lifecycle.
Position Responsibilities:
- Lead the Clinical Quality Assurance function, providing strategic direction and operational oversight for GCP quality across Scholar Rock-sponsored clinical trials, with a focus on biologics development programs.
- Serve as the senior GCP Quality partner to Clinical Operations, Clinical Development, Regulatory Affairs, Pharmacovigilance, Biometrics, Data Management, and other cross-functional stakeholders.
- Define, implement, and continuously mature the clinical quality strategy, governance model, and GCP quality management processes aligned with global regulatory expectations and clinical development priorities.
- Provide quality oversight for global clinical trials, including protocol compliance, informed consent processes, investigator site oversight, trial master file quality, data integrity, safety reporting interfaces, and clinical study documentation.
- Establish and execute a risk-based GCP audit program, including audits of investigator sites, CROs, vendors, clinical systems, TMF processes, and key internal clinical trial activities.
- Lead GCP inspection readiness activities and support preparation, conduct, response development, and follow-up for FDA, EMA, PMDA, and other health authority inspections.
- Provide oversight of GCP deviations, serious breaches, audit observations, inspection findings, CAPAs, and quality issues to ensure timely investigation, appropriate root cause analysis, effective corrective actions, and sustainable remediation.
- Oversee CRO and clinical vendor quality governance, including qualification, risk assessment, quality agreements where applicable, performance metrics, issue escalation, and continuous improvement.
- Partner with clinical and regulatory teams to proactively identify and mitigate quality risks associated with study design, trial execution, vendor performance, data integrity, patient safety, protocol deviations, and submission readiness.
- Develop and monitor GCP quality metrics, dashboards, and trend reports to support proactive risk management, governance discussions, and executive-level quality visibility.
- Author, review, and approve GCP-related SOPs, policies, quality plans, audit reports, CAPA plans, inspection materials, and other controlled documents as appropriate.
- Build, lead, and develop a fit-for-purpose Clinical QA function appropriate for a fast-paced, outsourced biotech operating model.
- Champion a culture of quality, accountability, patient safety, data integrity, transparency, and continuous improvement across internal teams and external partners.
Candidate Requirements:
- BS/MS degree in a scientific, healthcare, or related discipline; advanced degree preferred.
- 15+ years of experience in the pharmaceutical/biotech industry, including significant experience in Clinical Quality Assurance, Clinical Operations, clinical development, or related GCP compliance roles.
- 10+ years of hands-on GCP quality experience, including leadership of global clinical quality programs and oversight of Phase I–III clinical trials.
- Deep knowledge of ICH-GCP, ICH E6(R3), FDA, EMA, PMDA, and other global clinical trial regulations and expectations.
- Experience supporting biologics clinical development programs; late-stage development, registration-enabling studies, and inspection readiness experience strongly preferred.
- Demonstrated experience leading or supporting regulatory inspections, including inspection preparation, hosting, response development, CAPA management, and follow-up commitments.
- Strong experience with CRO and clinical vendor oversight, investigator site audits, TMF quality, clinical systems, data integrity, risk-based quality management, and quality issue escalation.
- Proven ability to design and mature fit-for-purpose GCP quality systems, SOPs, audit programs, quality metrics, governance forums, and inspection readiness frameworks in an outsourced biotech model.
- Strong judgment, executive presence, technical writing capability, and the ability to influence cross-functional leaders and external partners.
- Highly proactive, decisive, and capable of balancing strategic leadership with hands-on execution in a fast-paced environment.
- Engaged leader committed to building culture, mentoring talent, and developing scalable Clinical QA capabilities.
See All 180+ Clinical Director Jobs in Cambridge
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Find Clinical Director JobsClinical Director Job Market in Cambridge
Who's Hiring
- Takeda Pharmaceuticals41
- Bristol Myers Squibb23
- BioNTech17
- Scholar Rock17
- Sanofi12
Top Industries Hiring
- Biotechnology & Pharmaceuticals35
- Medical Devices6
- Science & Research6
Clinical Director Jobs in Cambridge: Frequently Asked Questions
How do I get a clinical director job in Cambridge?
Focus your search on Cambridge's three dominant hiring pockets: the Kendall Square biotech and life sciences corridor, the academic medical institutions clustered near Harvard and MIT, and the behavioral health and community health center networks in East Cambridge. Employers in these sectors prioritize candidates with direct program leadership experience, strong outcomes data, and familiarity with research-adjacent clinical environments. A background bridging clinical practice and operational management gives you a clear edge here.
Which companies hire clinical directors in Cambridge?
Companies currently hiring clinical directors in Cambridge include Takeda Pharmaceuticals, Bristol Myers Squibb, and BioNTech, per current listings on Migrate Mate as of August 2026. Cambridge's employer mix leans heavily toward research hospitals, life sciences firms, and community health organizations, making it one of the more varied clinical director markets in New England.
Are there remote clinical director jobs in Cambridge?
Yes, though remote availability is limited by nature since most clinical director roles involve direct oversight of staff, facilities, or patient-facing programs. About 74% of clinical director openings tied to Cambridge are remote or hybrid as of August 2026, skewing toward roles in utilization management, clinical operations strategy, and health services research. Fully on-site roles remain the norm for positions at hospitals and community health centers.
How can I get a clinical director job in Cambridge with little or no experience?
The most realistic entry path in Cambridge is moving into a clinical program manager or clinical operations lead role at one of the city's community health centers or behavioral health organizations, which tend to promote from within more actively than large academic hospitals. Lateral moves from senior clinical specialist or charge clinician positions are common stepping stones. Demonstrating measurable outcomes in a team lead capacity, even informally, strengthens a Cambridge application considerably.
Which industries hire the most clinical directors in Cambridge?
Most clinical director openings in Cambridge sit in Biotechnology & Pharmaceuticals, Medical Devices, and Science & Research, per current listings on Migrate Mate as of August 2026. Cambridge's concentration of world-class research institutions, biotech firms, and federally funded community health programs creates unusually consistent demand for clinical leadership across all three sectors.
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