Position Title: Director, Clinical Operations
Reports To: CMO
FLSA Status: Full-time, Exempt
Location: SF, Hybrid - In-office presence Tuesday, Wednesday & Thursday
POSITION SUMMARY:
The Director, Clinical Operations is responsible for the end-to-end management and oversight of assigned clinical investigations, across the United States and internationally, including those investigations conducted directly by Medicines360 and those conducted through Contract Research Organizations (CROs). This role partners cross-functionally with Regulatory, Safety, Data Management, Biostatistics, and Quality teams to drive study execution, proactively manage risks and ensure compliance with global regulatory standards. When working with a CRO, this role serves as the primary sponsor representative for operational execution, ensuring the CRO performance meets defined timelines, budget, quality, and ICH-ICP and global regulatory standards. This individual plays a critical role in translating clinical strategy into operational delivery.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Study Planning & Start-Up
- Leads protocol development and study design, including review and refinement of data requirements.
- Oversees country and site feasibility and selection strategy, including investigator assessments and start-up milestones.
- Leads project plans, timelines, resource plans, and study budget inputs, ensuring alignment with program goals.
- Ensures development and finalization of key study documents (e.g., protocol operational input, investigator brochures, informed consent forms, contracts, study manuals, regulatory submissions).
CRO Management, Trial Execution, Oversight and Close Out
- Leads end-to-end trial execution, including start-up, enrollment, maintenance, and close-out, ensuring adherence to clinical trial agreements, protocol, SOPs, and regulatory requirements.
- Leads site activation, training, and ongoing site engagement to ensure consistency and compliance, including participation in key site activities (e.g., site initiation, monitoring, and close-out visits).
- Oversees enrollment progress, study timelines, milestones, and proactively identifies and mitigates risks.
- Ensures ongoing TMF quality and inspection readiness throughout the study lifecycle.
- Serves as the accountable sponsor lead for CRO oversight, including:
- Ensuring CRO adherence to timelines, budget, scope of work, and quality expectations
- Leads regular governance meeting activities (e.g., study team meetings, vendor reviews, executive oversight)
- Reviewing and approving key CRO deliverables (e.g., project plans, monitoring plans, data management plans, timelines)
- Oversees study close-out activities, including data cleaning, database lock, and site close-out visits.
- Leads final reporting and ensures fulfillment of regulatory and contractual obligations.
Regulatory, Data Quality & Compliance
- Responsible for data collection processes, query resolution, and data integrity monitoring.
- Ensures compliance with ICH-GCP, FDA/EMA regulations, and internal SOPs.
- Responsible for safety data exchange with CROs or partners
- Oversee safety monitoring activities, including SAE reporting coordination.
- Facilitates communication with IRBs/ECs for submissions, amendments, and approvals.
- Support inspection readiness activities and participate in regulatory inspections and audits.
- Collaborate with Quality Assurance on audits, CAPAs, and broader compliance activities.
Financial & Vendor Management
- Responsible for CRO/vendor selection, including RFP development, bid evaluation, and negotiation of contracts and scopes of work.
- Build and maintain strong, accountable relationships with CROs and external vendors (e.g., labs, imaging, depots), ensuring coordination across global regions and functions
- Monitors vendor performance, issue resolution, and escalation pathways.
- Responsible for tracking and managing clinical trial budgets, forecasts, site payments, vendor invoices, and accruals in collaboration with Finance.
- Monitors CRO financial performance and manage change orders.
- Conducts financial reconciliation at study close-out.
Cross-Functional Communication
- Leads cross-functional study teams, ensuring alignment across Clinical Development, Regulatory Affairs, Safety/Pharmacovigilance, Biostatistics, Data Management, and Quality Assurance functions.
- Ensures transparency and alignment on study status, risks, milestones, and program priorities.
- Aligns study team objectives with broader program and corporate goals.
Risk Management & Reporting
- Identifies operational risks and lead development of mitigation and contingency plans.
- Provides regular status updates, dashboards, and reports to senior leadership.
- Escalates critical issues with clear recommendations and proposed solutions.
ESSENTIAL SKILLS & QUALIFICATIONS:
- Bachelor's degree in life sciences or related field (advanced degree preferred), with 5-8+ years of clinical trial management experience within a pharmaceutical, biotechnology, or CRO environment.
- Experience in women's health preferred; maternal health and perinatal research experience is a significant plus.
- Experience leading large multisite US clinical trials in medical devices, diagnostics, pharmaceuticals, or combination products, from initial planning and start-up through close-out and regulatory submissions. Global experience in various regions (e.g., North America, Europe, APAC, Africa) is highly desirable.
- Demonstrated experience managing complex specimen logistics and imaging workflows in global, multi-center studies, ensuring data integrity, traceability, and high-quality outputs that meet regulatory and scientific standards.
- Demonstrated success in vendor oversight and management, including CROs, laboratories, and other service providers for US and global studies.
- Experience in operational budget planning, forecasting, and financial management.
- Thorough knowledge of ICH-GCP and applicable regulatory requirements (e.g., FDA, EMA, and other global guidelines) for clinical trial authorization and execution.
- Strong interpersonal skills, with the ability to build effective relationships with investigators, physicians, vendors, and cross-functional partners.
- Outstanding written and verbal communication skills, including the ability to clearly communicate study status, risks, and outcomes to cross-functional teams, external partners, and senior leadership.
- Strong project management and execution skills, with a detail-oriented approach and the ability to manage complex global trials.
- Proactively identifies risks and issues and drives resolution in complex, fast-paced environments.
- Demonstrates the ability to motivate and influence teams to achieve results, ensuring accountability and promoting a culture of trust, transparency, and collaboration.
- Effectively collaborate across teams and leadership levels, with the ability to align stakeholders to program and organizational goals.
- Proficiency in Microsoft Office, including advanced MS Project skills, and experience with project management tools, methodologies, and clinical trial systems.
- Ability and willingness to travel up to 30%, including international travel as required.
IN OFFICE PRESENCE: Tuesday, Wednesday & Thursday
PHYSICAL DEMANDS/MISC:
- Must be able to remain in a stationary position 50% of the time.
- The person in this position may need to occasionally move throughout the office to attend meetings in different rooms.
- Continuously operates a computer and occasionally uses other office productivity machinery, such as a copy machine and a computer printer
- The ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in these situations.
- The ability to observe details at close range (within a few feet of the observer)
