Key Responsibilities and Required Skills for Clinical Trials Director Lead

🎯 Role Definition

We are seeking an experienced Clinical Trials Director Lead (also referenced as Director of Clinical Operations / Head of Clinical Trials) to own end‑to‑end delivery of global clinical programs. This role combines strategic program leadership, operational execution, regulatory oversight and cross‑functional stakeholder management to ensure trials are delivered on time, within budget and to the highest quality and compliance standards (GCP, ICH, FDA/EMA). The Clinical Trials Director Lead will manage clinical teams, direct CRO and vendor partnerships, drive patient recruitment and retention strategies, and partner with development, safety, regulatory and commercial functions to meet program milestones.

📈 Career Progression

Typical Career Path

Entry Point From:

Senior Clinical Project Manager / Senior Clinical Operations Manager
Head of Clinical Operations or Global Clinical Lead
Clinical Development Lead or Therapeutic Area Lead

Advancement To:

Vice President, Clinical Operations
Global Head of Clinical Development
Chief Clinical Officer / Head of R&D

Lateral Moves:

Program Director, Clinical Development Strategy
Head of Clinical Quality and Compliance
Pharmacovigilance or Safety Science Lead

Core Responsibilities

Primary Functions

Own full program leadership for multiple concurrent clinical trials (Phases I–IV), including protocol implementation, operational planning, clinical study timelines, resource allocation, and milestone tracking to ensure timely delivery of primary and secondary endpoints.
Develop and execute comprehensive trial strategies including study design inputs, patient population definition, feasibility assessments, site selection criteria, and enrollment acceleration plans to meet recruitment targets and minimize timelines.
Lead CRO selection, contracting, oversight and performance management; establish clear KPIs/SLAs, conduct regular governance meetings, and drive corrective action plans to maintain CRO accountability and quality of deliverables.
Build, mentor, and lead cross‑functional clinical operations teams (project managers, clinical research associates, clinical operations leads) and ensure role clarity, development plans, and high‑performance delivery culture.
Prepare, manage and forecast clinical trial budgets and financial models; approve spend, track burn rates, optimize resource utilization, and present budget variance and risk mitigation strategies to senior leadership.
Oversee clinical study start‑up activities including site activation, clinical supply planning, IRB/EC submissions, local regulatory approvals (IND/CTA support), contracting, and investigator agreements to ensure rapid study initiation.
Ensure compliance with ICH‑GCP, FDA, EMA and local regulations; implement and maintain SOPs, working instructions and quality systems to pass audits and regulatory inspections.
Manage clinical trial safety oversight in partnership with PV/Safety teams and the medical monitor; ensure timely adverse event (AE/SAE) reporting, safety signal detection, and adherence to DSMB/IDMC recommendations.
Own protocol change control and amendment implementation; assess operational impact, budget/timeline implications, and communicate changes to sites, CROs and regulatory bodies.
Drive risk‑based monitoring and quality by design approaches; define monitoring plans, leverage remote/eSource/eClinical tools, and implement corrective and preventive actions based on monitoring findings.
Oversee data management and eClinical systems coordination (EDC, CTMS, eTMF, ePRO), ensuring data integrity, clean dataset delivery, data lock timelines and alignment with biostatistics and medical writing teams.
Lead investigator selection and engagement, conduct investigator meetings, and maintain strong relationships with key opinion leaders (KOLs) and site networks to support recruitment and scientific input.
Collaborate with Clinical Development, Regulatory Affairs and Biostatistics to prepare regulatory submissions (IND/CTA packages), integrated clinical study reports (CSRs), and briefing documents for meetings with health authorities.
Implement and track meaningful performance metrics (enrollment pace, query resolution time, site startup cycle time, protocol deviations) and deliver regular program status reporting and executive summaries to stakeholders.
Coordinate clinical supply and investigational product logistics with supply chain and depots; ensure blinding/randomization integrity, stability, labeling, and timely distribution to sites.
Lead feasibility and site performance assessments; deploy targeted site training, investigator support, and remediation strategies to improve underperforming sites and accelerate enrollment.
Serve as the primary escalation point for operational issues, complex protocol deviations, regulatory queries, and sponsor/CRO disputes; lead root cause analyses and implement sustainable process improvements.
Partner with Commercial, Market Access and Medical Affairs to align clinical development with lifecycle planning, evidence generation strategies and label optimization.
Oversee vendor oversight beyond CROs (central labs, imaging vendors, PK/PD vendors, patient engagement platforms), managing SOWs, timelines, quality deliverables and integrated project plans.
Facilitate cross‑functional governance including Program Steering Committees, clinical safety boards, and operational working groups; ensure decisions are documented and action items executed.
Drive patient‑centric initiatives and retention programs (travel support, eConsent, digital health tools, decentralized clinical trial elements) to improve recruitment, minimize dropouts, and enhance data quality.
Champion continuous improvement through lessons learned capture, SOP updates, and process harmonization across programs to increase operational efficiency and reduce cycle times.
Prepare and support global and local audit/inspection readiness activities; lead mock inspections, remediate findings, and maintain inspection‑ready documentation in the eTMF.

Secondary Functions

Support ad-hoc data requests and exploratory data analysis.
Contribute to the organization's data strategy and roadmap.
Collaborate with business units to translate data needs into engineering requirements.
Participate in sprint planning and agile ceremonies within the data engineering team.
Assist medical writing and clinical regulatory teams with operational inputs for protocols, IBs and CSRs to ensure feasibility and alignment with operational realities.
Provide mentorship and interview support for hiring clinical operations staff; participate in workforce planning and capacity modeling.
Contribute to cross‑functional initiatives such as digital transformation, eSource/eCOA adoption and decentralized trial pilots to modernize trial operations.

Required Skills & Competencies

Hard Skills (Technical)

Clinical trial operations management across Phases I–IV and/or adaptive designs.
Deep knowledge of ICH‑GCP, FDA, EMA regulations, and local regulatory submission processes (IND, CTA).
Experience managing CROs, central vendors, and multi‑vendor ecosystems with robust vendor governance.
Budgeting, financial forecasting and cost‑control for large, multi‑site global programs.
Proficiency with eClinical systems: EDC, CTMS, eTMF, IVRS/IWRS, ePRO/eCOA and integration strategies.
Risk‑based monitoring, quality assurance, audit readiness and CAPA implementation.
Clinical supply and randomization management, blinding/unblinding procedures and logistics coordination.
Protocol development and amendment lifecycle management with operational feasibility assessments.
Safety reporting coordination with pharmacovigilance and medical monitoring teams (AE/SAE handling).
Metrics, KPIs and data‑driven program reporting; ability to articulate program health to executives.
Experience with decentralized clinical trial (DCT) components and patient engagement technologies.
Vendor contracting, SOW negotiation and SLA/KPI development.

Soft Skills

Strategic leadership with proven ability to lead large, geographically dispersed teams.
Excellent stakeholder management and cross‑functional collaboration skills.
Strong communication and presentation skills for executive briefings and regulatory interactions.
Decision‑making under uncertainty and prioritization of competing program demands.
Problem solving and root cause analysis mindset; drives sustainable corrective actions.
Influencing and negotiation skills across external partners and internal stakeholders.
Coaching and talent development to build high‑performing clinical operations teams.
Adaptability in fast‑paced, high‑complexity R&D environments.
Patient‑centric mindset and empathy for site and participant burden.
Strong organizational skills and attention to detail with a quality‑first focus.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.

Preferred Education:

Advanced degree (MS, MPH, MBA, PharmD) or equivalent experience.
Clinical research certifications (ACRP, SOCRA) or Project Management certification (PMP) a plus.

Relevant Fields of Study:

Clinical Research / Clinical Operations
Nursing, Pharmacy, Medicine, Biomedical Sciences
Public Health, Epidemiology, Life Sciences

Experience Requirements

Typical Experience Range: 10–15+ years in clinical research, with progressive responsibility in clinical operations.

Preferred:

Minimum 8–10 years managing global clinical trials and at least 3–5 years in a director or senior leadership role overseeing multiple programs or a portfolio.
Demonstrated experience delivering complex, multi‑country protocols with CRO/vendor management, regulatory interactions and successful audit/inspection outcomes.
Therapeutic area experience preferred (e.g., oncology, immunology, CNS, rare disease) depending on program needs.
Track record of implementing operational efficiencies, decentralized trial elements, and patient recruitment strategies that measurably improved study performance.