Key Responsibilities and Required Skills for Clinical Research Director

🎯 Role Definition

The Clinical Research Director provides strategic and operational leadership for clinical development programs across therapeutic areas. This role defines clinical strategy, designs and executes study protocols, manages budgets and vendor partners, ensures patient safety and data quality, and drives recruitment and retention to meet clinical milestones. The Director partners with medical affairs, regulatory, biometrics, commercial and executive leadership to translate pipeline goals into high‑quality, regulatory‑ready clinical evidence.

📈 Career Progression

Typical Career Path

Entry Point From:

Senior Clinical Project Manager / Program Manager
Clinical Operations Manager / Head of Clinical Operations
Clinical Scientist / Medical Director (clinical development)

Advancement To:

Vice President, Clinical Development
Head of Clinical Operations / Global Head of Clinical
Chief Medical Officer / Chief Development Officer

Lateral Moves:

Head of Regulatory Affairs
Director of Medical Affairs
Head of Clinical Quality & Compliance

Core Responsibilities

Primary Functions

Lead end‑to‑end execution of clinical development programs (Phase I–IV), defining study strategy, protocol objectives, endpoints, inclusion/exclusion criteria, operational timelines, and milestone delivery to support regulatory submissions and commercialization.
Develop, review and approve clinical study protocols, informed consent documents, investigator brochures and related clinical documentation to ensure scientific rigor and regulatory readiness.
Own study budgets, financial forecasts and resource planning — prepare budget proposals, negotiate study and site budgets, monitor spend vs forecast, and deliver cost‑efficient clinical operations.
Select, negotiate and manage CROs, clinical vendors, central laboratories, imaging vendors and other external partners; define vendor scope, KPIs, SLAs and governance to ensure on‑time, on‑budget delivery.
Define and implement site selection, feasibility and activation strategies; oversee site initiation, monitoring plan, query resolution and close‑out activities to maximize enrollment and data quality.
Drive patient recruitment and retention strategy in collaboration with patient advocacy, commercial and site teams; deploy digital recruitment, site engagement and retention programs to meet enrollment targets.
Ensure compliance with GCP, ICH guidelines, local regulations and company SOPs; prepare teams and studies for audits and inspections by sponsors, agencies and ethics committees.
Oversee safety surveillance and pharmacovigilance for clinical programs; ensure timely SAE/AE reporting, risk assessment, root cause analysis and communications with regulatory authorities.
Provide clinical oversight for data quality, integrity and completeness; partner with data management, biostatistics and medical writing to ensure accurate datasets and timely statistical analysis plans.
Chair or participate in study steering committees, cross‑functional governance forums and executive program reviews; present program status, risks, mitigations and strategic decisions to senior leadership and external stakeholders.
Develop and implement risk mitigation and contingency plans for operational, regulatory and enrollment challenges; monitor program risk register and drive corrective actions.
Build, mentor and lead clinical operations teams including project managers, CRA leads, clinical managers and study personnel; define org structure, performance goals and development plans.
Lead protocol amendments, change control and impact assessments; evaluate operational implications, reforecast budgets and timelines and communicate changes to stakeholders.
Oversee regulatory submissions and interactions (IND/IDE/CTA/IMPD) in partnership with regulatory affairs; prepare briefing packages, responses to agency queries and inspection materials.
Establish and monitor study KPIs (enrollment rate, site performance, query turnaround, DMC/DSMB actions) and implement dashboards for transparent program tracking and continuous improvement.
Ensure proper use and integration of clinical technologies such as EDC, CTMS, ePRO, eConsent and safety systems; drive digital adoption to streamline operations and reporting.
Lead investigator and site relationship management; negotiate investigator agreements, manage site escalations and ensure high quality investigator engagement and training.
Oversee vendor selection and contract negotiations for biomarker, imaging and specialty testing; ensure vendor qualification, contract compliance and deliverable quality.
Ensure all studies adhere to patient privacy and data protection regulations (HIPAA, GDPR) and company data governance policies; collaborate with privacy and legal teams on consent language and data sharing.
Design and execute registries, post‑marketing studies and real‑world evidence initiatives; align post‑marketing strategy with clinical development and commercial objectives.
Develop and maintain standard operating procedures (SOPs), work instructions and clinical quality frameworks; coach teams on best practices and ensure SOP adherence.
Coordinate clinical supply strategy and management (IMP) with clinical supply chain to ensure timely distribution, blinding processes and accountability for investigational products.
Support business development and licensing activities by providing clinical input to due diligence, feasibility assessments and target evaluation.
Lead pre‑approval and launch study activities, liaising with regulatory, commercial and medical affairs to ensure readiness for product launch and life‑cycle management.

Secondary Functions

Partner with clinical analytics and data science teams to generate ad hoc analyses, feasibility models and enrollment forecasts that inform site selection and portfolio prioritization.
Contribute to the organization’s clinical operations strategy, process improvements and digital roadmap (CTMS, EDC, RWD integration).
Represent the company at investigator meetings, scientific conferences and advisory boards to build external networks and inform clinical strategy.
Support cross‑functional initiatives such as therapeutic area pipeline reviews, quality management system enhancements and training programs.
Provide clinical expertise for marketing, reimbursement and HEOR initiatives to align clinical evidence generation with payer and market access needs.
Participate in vendor audits and site monitoring quality reviews to ensure corrective and preventative actions (CAPAs) are implemented and effective.

Required Skills & Competencies

Hard Skills (Technical)

Deep knowledge of Good Clinical Practice (GCP), ICH guidelines and global regulatory frameworks (FDA, EMA, MHRA).
Experience preparing and managing IND/IDE/CTA submissions and responses to regulatory agencies.
Proven track record of designing clinical protocols and statistical collaboration with biostatistics teams.
Strong clinical operations skills across site management, monitoring strategy, CRA oversight and study start‑up.
Expertise in CRO selection, management and performance governance, including contracting and SLAs.
Proficiency with clinical systems: CTMS, EDC (e.g., Medidata Rave, Oracle, Veeva), eConsent/ePRO platforms and safety databases.
Budgeting, financial forecasting and P&L ownership for clinical programs.
Knowledge of pharmacovigilance and safety reporting workflows, SAE management and risk assessment.
Experience with decentralized clinical trial elements, remote monitoring, and hybrid trial designs.
Familiarity with real‑world evidence, registries, and post‑marketing study design and execution.
Understanding of clinical supply chain and IMP management logistics.
Ability to read and interpret statistical outputs and clinical study reports; experience producing regulatory‑ready clinical study reports (CSRs).

Soft Skills

Strategic leadership and program-level thinking with a bias for measurable delivery.
Excellent written and verbal communication for interfacing with investigators, regulators and executive leadership.
Strong stakeholder management and influencing skills across cross‑functional teams.
Exceptional problem solving, prioritization and decision‑making under ambiguity and changing timelines.
Team building, coaching and talent development to create high‑performing clinical teams.
High attention to detail and quality mindset; commitment to compliance and patient safety.
Negotiation skills for vendor and investigator contract discussions.
Adaptability and resilience in fast‑moving development programs and complex regulatory environments.
Collaborative mindset with ability to translate scientific objectives into operational plans.
Data‑driven orientation and comfort using dashboards and KPIs to guide program actions.

Education & Experience

Educational Background

Minimum Education:

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

Preferred Education:

Advanced degree (MS, MPH, PharmD, MD, PhD) strongly preferred for strategic and medical decision making.
Certification in Clinical Research (e.g., ACRP, SOCRA) or Project Management (PMP) is a plus.

Relevant Fields of Study:

Medicine / Clinical Medicine
Pharmacy / Clinical Pharmacy
Nursing
Life Sciences / Biology / Biochemistry
Public Health / Epidemiology
Clinical Research / Regulatory Science

Experience Requirements

Typical Experience Range: 10–20+ years in clinical research and development, with progressive operational and program leadership responsibilities.

Preferred:

5+ years of direct people leadership managing clinical teams and vendors.
Demonstrated experience managing Phase II and Phase III trials in biotech or pharmaceutical settings.
Prior experience working with global/regulatory submissions (FDA/EMA) and supporting inspections.
Track record of successfully delivering enrollment, timelines and regulatory milestones across complex, multi‑center studies.
Experience in therapeutic area relevant to company pipeline (e.g., oncology, neurology, rare disease) is highly desirable.