Key Responsibilities and Required Skills for Oncology Clinical Director

🎯 Role Definition

The Oncology Clinical Director is a senior physician-scientist or experienced clinical development leader accountable for the medical strategy and operational delivery of oncology clinical trials and programs. This role combines clinical expertise in medical oncology and hematology-oncology with hands-on experience in protocol development, regulatory interactions (INDs/CTA), safety monitoring, and cross-functional team leadership (clinical operations, biostatistics, regulatory affairs, translational science, medical affairs and commercial). The Oncology Clinical Director drives evidence generation, ensures patient safety and data integrity, mentors clinical teams, and represents the program externally with key opinion leaders, investigators, CRO partners, and regulatory agencies.

📈 Career Progression

Typical Career Path

Entry Point From:

Senior Medical Monitor / Medical Director (Oncology)
Practicing Medical Oncologist with clinical trial leadership experience
Therapeutic Area Lead, Oncology (Clinical Development)

Advancement To:

Head of Clinical Development (Oncology)
Vice President, Clinical Development
Chief Medical Officer (CMO) or Global Medical Director (Oncology)

Lateral Moves:

Medical Affairs Director / Head of Medical Affairs (Oncology)
Head of Clinical Operations for Oncology

Core Responsibilities

Primary Functions

Lead the medical strategy for one or more oncology programs, translating preclinical and translational data into robust clinical development plans and evidence-generation strategies across Phase I–III and post-approval studies.
Develop, review and approve clinical study protocols, informed consents, investigator brochures and clinical study reports ensuring scientific rigor and regulatory alignment with FDA, EMA and other global health authorities.
Serve as the primary medical monitor across key oncology clinical trials, overseeing patient safety, SAE assessment, unblinded safety reviews (as needed), and medical interpretation of safety signals; author and sign safety and briefing documents.
Provide expert medical review and sign-off for IND/CTA submissions, regulatory briefing packages, responses to health authority queries and support global regulatory interactions and advisory committee preparation.
Design and implement clinical endpoints, statistical analysis plans and comparator strategies specific to oncology indications (e.g., OS, PFS, ORR, DOR, minimal residual disease, patient-reported outcomes) and liaise with biostatistics to ensure evaluable endpoints.
Oversee investigator selection, site feasibility assessments, and site initiation activities; build and maintain strong relationships with key opinion leaders (KOLs), principal investigators and academic centers to support enrollment and scientific credibility.
Partner with clinical operations and CROs to ensure on-time site activation, patient recruitment, retention strategies, and operational delivery of complex oncology trials including combination and biomarker-driven studies.
Lead cross-functional risk assessments and mitigation plans (risk-based monitoring, contingency planning) to preserve timelines, quality and patient safety while managing protocol amendments and deviations.
Drive biomarker and translational medicine strategy in collaboration with translational scientists and pathology partners—design tissue acquisition, companion diagnostic strategies, and genomic profiling to support patient selection and precision oncology approaches.
Provide clinical input to safety management plans, data monitoring committee (DMC) charters and prepare materials for independent safety reviews and interim analyses.
Manage and mentor clinical development staff, medical monitors and physician advisors; recruit, develop and retain high-performing clinical teams and foster a culture of clinical excellence and compliance.
Own clinical deliverables for internal governance committees (Development Steering Committee, Clinical Review Board) and prepare concise, high-impact medical summaries, slide decks and leadership updates to advance decision-making.
Collaborate with regulatory affairs, CMC and nonclinical leads to integrate medical strategy with chemistry, manufacturing and controls activities and ensure alignment for global submissions and labeling strategies.
Support safety signal detection and pharmacovigilance activities by reviewing aggregate safety data, authoring clinical safety narratives, and contributing to Periodic Benefit-Risk Evaluation Reports (PBRERs) and IND safety updates.
Lead go/no-go decisions at clinical inflection points by synthesizing clinical, safety and biomarker data and delivering recommendations to senior leadership based on benefit-risk and competitive landscape assessment.
Contribute to strategic business development and licensing discussions by conducting due diligence reviews of external oncology assets and drafting medical opinions and development plans for partnering opportunities.
Ensure compliance with GCP, internal SOPs and ethical standards; prepare teams for regulatory inspections and clinical audits and respond to audit findings with corrective and preventive actions.
Drive publication and scientific communication strategy: author or co-author manuscripts, abstracts, and conference presentations; coordinate scientific exchange programs and investigator meetings to maximize clinical impact.
Oversee budget forecasting, resource planning and vendor contracts for clinical programs; partner with finance to manage clinical spend and optimize cost-effective study execution.
Champion patient-centric trial design and enrollment initiatives including decentralized trial approaches, patient-reported outcomes, supportive care measures, and community oncology engagement to broaden access.
Provide medical leadership in cross-disciplinary tumor boards, scientific advisory boards and protocol development meetings to ensure clinical relevance and uptake by treating physicians.
Ensure high-quality data integrity by working closely with data management and biostatistics teams to address data queries, adjudicate endpoints and support statistical review and clinical interpretation of results.

Secondary Functions

Support development and continuous improvement of clinical SOPs, templates and best practices to accelerate study start-up and reduce operational friction.
Serve as the medical lead in vendor selection and oversight for central labs, imaging vendors, and contract research organizations; negotiate clinical service agreements and SLAs.
Represent the company at external conferences, KOL meetings and advisory boards to build scientific reputation and gather competitive intelligence.
Conduct training sessions for clinical teams, field medical, and commercial colleagues on study protocols, safety profiles and evolving oncology science.
Participate in cross-functional sprint planning, program governance meetings and contribute to clinical development roadmaps and milestone planning.
Provide ad-hoc clinical input to real-world evidence (RWE) and health economics projects to support HTA and payer engagement strategies.
Assist commercial and market access teams with clinical value propositions, label interpretation and medical training materials for oncology products.
Support compassionate use, expanded access and single-patient IND/authorization requests where medically appropriate.

Required Skills & Competencies

Hard Skills (Technical)

Clinical oncology expertise (medical oncology/hematology-oncology) with demonstrated experience managing solid tumors and/or hematologic malignancies.
Extensive knowledge of clinical trial design and execution across phases I–III, including dose-escalation designs, expansion cohorts, randomized controlled trials and seamless designs.
Strong regulatory expertise: experience preparing and supporting IND/CTA submissions, responding to regulatory queries, and participating in health authority meetings (FDA, EMA).
Proficiency in GCP, ICH guidelines, and global regulatory requirements for clinical research and safety reporting (ICH E2A/E2C/E6).
Medical monitoring and pharmacovigilance skills: SAE review, aggregate safety review, risk management plans and safety narrative writing.
Protocol writing, clinical study report (CSR) authoring and experience creating Investigator’s Brochures and clinical development plans.
Biomarker, molecular diagnostics and companion diagnostic strategy experience, including integration of next-generation sequencing (NGS) and circulating tumor DNA (ctDNA) into trials.
Experience managing CROs, central labs, imaging vendors, and external clinical partners; contract negotiation and vendor oversight.
Working knowledge of clinical trial systems and tools (CTMS, EDC, ePRO, MedDRA coding, AE/SAE reporting systems).
Quantitative literacy to interpret biostatistical outputs, survival analyses, hazard ratios, and interim analyses.
Experience with oncology-specific endpoints and patient-reported outcomes; familiarity with oncology guidelines (NCCN, ESMO).
Familiarity with real-world evidence generation, registries, and use of EHR-derived data in oncology research.

Soft Skills

Strategic leadership with demonstrated ability to set clinical direction, prioritize high-impact activities and make informed go/no-go decisions.
Excellent written and verbal communication skills for interacting with internal leadership, investigators, regulatory bodies and external stakeholders.
Strong stakeholder management and influencing skills across cross-functional teams (clinical ops, regulatory, translational, commercial).
Problem-solving orientation and ability to operate under ambiguity in a fast-paced drug development environment.
Team-building and mentorship skills with experience developing junior clinical staff and fostering multidisciplinary collaboration.
High ethical standards, integrity and commitment to patient safety and clinical compliance.
Adaptability and resilience with experience managing complex, global programs and competing priorities.
Diplomacy and negotiation skills for vendor contracts, investigator agreements and KOL engagement.
Project management mindset with focus on timelines, deliverables and resource optimization.
Cultural awareness and ability to work effectively across global teams and diverse clinical settings.

Education & Experience

Educational Background

Minimum Education:

MD, DO, or MD/PhD with board certification in Medical Oncology or Hematology-Oncology; alternatively PharmD or PhD with extensive clinical development experience in oncology (senior non-MD roles may be considered).

Preferred Education:

MD/PhD in Oncology or Translational Medicine, or advanced degrees (MBA, MSc Clinical Research) in combination with clinical development leadership experience.

Relevant Fields of Study:

Medical Oncology / Hematology-Oncology
Internal Medicine
Clinical Research / Clinical Pharmacology
Pharmacology / Translational Medicine
Molecular Oncology / Genomics

Experience Requirements

Typical Experience Range: 8–15+ years of combined clinical and clinical development experience, with progressive responsibility.

Preferred:

10+ years of oncology clinical practice and 5+ years in clinical development or medical affairs for oncology programs.
Demonstrated track record of leading multiple oncology studies from IND through NDA/BLA or regulatory submission readiness.
Prior experience working with global trials, health authority interactions, DMCs and cross-functional leadership in biotech, pharma or academic clinical research organizations.