Jennifer Price Life Sciences, LLC
Director Clinical Operations (+-)
Jennifer Price Life Sciences, LLC, Boston, Massachusetts, us, 02298
Director, Clinical Operations
Jennifer Price Life Sciences, LLC provided pay range
This range is provided by Jennifer Price Life Sciences, LLC. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $190.00/yr – $230.00/yr
The Director, Clinical Operations will lead the strategic planning, execution, and oversight of clinical programs across multiple phases of development with a strong emphasis in phase II. This leader will provide operational direction to internal teams and external partners to ensure high‑quality delivery of studies, adherence to timelines, and full compliance with GCP and regulatory standards. The role is ideal for a collaborative, proactive operations leader who thrives in a fast‑moving biotech environment and enjoys building structure, solving problems, and guiding teams through complex clinical execution.
Key Responsibilities Clinical Strategy & Leadership
Develop and execute operational strategies that support the clinical development plan and company milestones.
Serve as a key partner to Clinical Development, Regulatory, Biometrics, and Program Management to align operational plans with program goals.
Provide leadership, coaching, and mentorship to Clinical Operations team members.
Study Execution & Oversight
Lead end‑to‑end operational delivery of clinical studies, ensuring quality, compliance, and on‑time performance.
Oversee vendor selection, contracting, and ongoing management (CROs, central labs, eCOA, imaging, etc.).
Ensure study plans, monitoring oversight, risk mitigation strategies, and timelines are robust and well‑executed.
Clinical Site Engagement
Guide site identification, feasibility, and selection activities to support enrollment targets.
Partner with clinical teams and vendors to strengthen site relationships and address operational challenges proactively.
Quality & Compliance
Ensure all studies are conducted in accordance with GCP, ICH guidelines, and relevant regulatory requirements.
Lead inspection readiness activities and support regulatory interactions as needed.
Implement and maintain operational SOPs, best practices, and continuous improvement initiatives.
Cross‑Functional Collaboration
Partner with Biometrics, Medical Affairs, CMC, and Supply Chain to ensure seamless study support.
Contribute to program‑level planning, forecasting, and budgeting processes.
Support development of clinical documents including protocols, IBs, study manuals, and regulatory submissions.
Qualifications
Bachelor’s degree in life sciences or related field; advanced degree preferred.
10+ years of clinical operations experience in biotech or pharmaceutical environments, including leadership responsibility.
Demonstrated success overseeing Phase 1–3 studies, ideally including rare disease or neurology programs.
Strong experience managing CROs and global vendors.
Proven ability to lead teams, collaborate cross‑functionally, and drive execution in a dynamic setting.
Exceptional communication, problem‑solving, and organizational skills.
Comfortable working in an environment where processes evolve as the company grows.
Personal Attributes
Energetic, collaborative, and highly organized.
Enjoys working in a high‑accountability, mission‑driven culture.
Able to balance strategic thinking with hands‑on operational leadership.
Builds strong relationships with internal teams, sites, vendors, and leadership.
Seniority level Director
Employment type Full‑time
Job function Project Management
Industries: Biotechnology Research and Pharmaceutical Manufacturing
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This range is provided by Jennifer Price Life Sciences, LLC. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $190.00/yr – $230.00/yr
The Director, Clinical Operations will lead the strategic planning, execution, and oversight of clinical programs across multiple phases of development with a strong emphasis in phase II. This leader will provide operational direction to internal teams and external partners to ensure high‑quality delivery of studies, adherence to timelines, and full compliance with GCP and regulatory standards. The role is ideal for a collaborative, proactive operations leader who thrives in a fast‑moving biotech environment and enjoys building structure, solving problems, and guiding teams through complex clinical execution.
Key Responsibilities Clinical Strategy & Leadership
Develop and execute operational strategies that support the clinical development plan and company milestones.
Serve as a key partner to Clinical Development, Regulatory, Biometrics, and Program Management to align operational plans with program goals.
Provide leadership, coaching, and mentorship to Clinical Operations team members.
Study Execution & Oversight
Lead end‑to‑end operational delivery of clinical studies, ensuring quality, compliance, and on‑time performance.
Oversee vendor selection, contracting, and ongoing management (CROs, central labs, eCOA, imaging, etc.).
Ensure study plans, monitoring oversight, risk mitigation strategies, and timelines are robust and well‑executed.
Clinical Site Engagement
Guide site identification, feasibility, and selection activities to support enrollment targets.
Partner with clinical teams and vendors to strengthen site relationships and address operational challenges proactively.
Quality & Compliance
Ensure all studies are conducted in accordance with GCP, ICH guidelines, and relevant regulatory requirements.
Lead inspection readiness activities and support regulatory interactions as needed.
Implement and maintain operational SOPs, best practices, and continuous improvement initiatives.
Cross‑Functional Collaboration
Partner with Biometrics, Medical Affairs, CMC, and Supply Chain to ensure seamless study support.
Contribute to program‑level planning, forecasting, and budgeting processes.
Support development of clinical documents including protocols, IBs, study manuals, and regulatory submissions.
Qualifications
Bachelor’s degree in life sciences or related field; advanced degree preferred.
10+ years of clinical operations experience in biotech or pharmaceutical environments, including leadership responsibility.
Demonstrated success overseeing Phase 1–3 studies, ideally including rare disease or neurology programs.
Strong experience managing CROs and global vendors.
Proven ability to lead teams, collaborate cross‑functionally, and drive execution in a dynamic setting.
Exceptional communication, problem‑solving, and organizational skills.
Comfortable working in an environment where processes evolve as the company grows.
Personal Attributes
Energetic, collaborative, and highly organized.
Enjoys working in a high‑accountability, mission‑driven culture.
Able to balance strategic thinking with hands‑on operational leadership.
Builds strong relationships with internal teams, sites, vendors, and leadership.
Seniority level Director
Employment type Full‑time
Job function Project Management
Industries: Biotechnology Research and Pharmaceutical Manufacturing
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