Vice President Clinical Development - Immuno/Oncology

Kaye/Bassman International; United States; On-site; USD 300,000 - 550,000; Full time

Benefits offered by this job

Medical/Dental/Vision coverage

401(k) match

Employee Stock Purchase Plan

Education assistance

Flexible Spending Accounts

Care.com memberships

Flexible vacation plan

EAP – mental health & well-being

Job summary

Undisclosed client in oncology seeks a Vice President of Clinical Development to lead global oncology programs, with emphasis on a next-generation immunotherapy combo entering registrational Phase 3. The role requires a physician-scientist with deep hands-on experience in early- to late-stage development and a track record with regulatory interactions.

The leader will own development strategy, indication prioritization, and study design, while mentoring teams and collaborating with

Qualifications

• MD or international equivalent with oncology drug development experience.
• Significant experience leading global clinical development programs from early phase through registrational studies, incl. Phase 3.
• Experience preparing global regulatory submissions (BLA/NDA/MAA).
• Strong ability to lead cross-functional teams and influence program strategy at senior leadership level.
• Excellent written and verbal communication skills for complex scientific concepts.
• Ability to make sound medical decisions in ambiguous situations and communicate recommendations.

Responsibilities

• Provide strategic and medical leadership for assigned oncology development programs.
• Lead integrated clinical development plans from early to late-stage and registrational development.
• Translate emerging clinical data into actionable development strategies and decisions.
• Act as Medical Monitor and oversee patient safety and protocol compliance.
• Author and review key study documents and regulatory submissions.
• Represent clinical development to health authorities and governance committees.
• Collaborate cross-functionally with Clinical Operations, Data Management and Biostatistics.

Skills

Oncology drug development experience

Clinical development leadership

Regulatory submissions knowledge

KOL engagement

Scientific communication

Cross-functional leadership

Data interpretation

Education

MD or international equivalent

Job description

Our client is an established, clinical-stage immuno-oncology company focused on unleashing the body's immune system to treat and potentially cure cancer.

Its lead program - a next-generation dual checkpoint-inhibitor immunotherapy combination - is entering registrational Phase 3 development in a large gastrointestinal solid-tumor indication, backed by recent financing and growing early-access programs.

A lean, hands-on biotech culture where senior leaders stay close to the science and the data, and where individual contributions visibly shape the program.

The Role They Will Play

The Vice President, Clinical Development will provide strategic and medical leadership for the company's global oncology development programs, with a particular focus on its lead immunotherapy combination.

With the lead program advancing into registrational Phase 3 development and expanding patient access through authorized early-access programs, this is an opportunity to play a central role in shaping the next stage of a potentially transformative oncology program. This individual will serve as a senior clinical leader while remaining highly engaged in the medical monitoring and scientific oversight of clinical trials, bringing a hands-on approach, strong medical judgment, and the ability to translate emerging clinical data into clear development strategies and decisions.

Reporting to the Chief Medical Officer, this leader will own development strategy, indication and patient-population prioritization, and study design for a registrational program, and will represent the clinical perspective in health-authority interactions. Unlike larger-company roles, it combines senior strategic ownership with direct, hands-on proximity to the data - and the opportunity to lead a program toward the finish line.

Key Responsibilities

Global Clinical Development & Program Leadership

• Provide strategic and medical leadership for assigned global oncology development programs, driving clinical development strategy, study design, indication and patient population strategy, and key program decisions.
• Lead the development and execution of integrated clinical development plans spanning early- through late-stage and registrational development, ensuring individual studies support broader program, regulatory, and product objectives.
• Translate emerging efficacy, safety, biomarker, and competitive data into actionable development strategy, including recommendations regarding study design, patient selection, combination strategies, and future development opportunities.
• Provide clinical leadership for late-stage and registrational programs, including Phase 3 development and preparation for global regulatory submissions and potential marketing applications.
• Represent Clinical Development and assigned programs with senior leadership and governance committees, clearly communicating clinical strategy, emerging data, program risks, and recommendations to drive timely decision making.
• Serve as a visible scientific and clinical leader for assigned programs with investigators, KOLs, regulatory authorities, and external partners.

Medical Monitoring & Patient Safety

• Act as Medical Monitor for assigned clinical trial(s), providing medical oversight to ensure patient safety, protocol compliance, and scientific integrity throughout study conduct.
• Provide medical oversight for ongoing safety surveillance, including timely review and assessment of adverse events, protocol deviations, eligibility questions, and other medical issues arising during study conduct.
• Evaluate evolving clinical data in situations where information may be incomplete or ambiguous, applying sound medical judgment to make timely decisions while clearly communicating scientific rationale, differing viewpoints, risks, and recommendations to cross-functional stakeholders.

Clinical Development & Data Leadership

• Lead the ongoing review, curation, interpretation, and analysis of clinical trial data, ensuring data quality, completeness, consistency, and scientific integrity while identifying emerging efficacy and safety trends that inform development decisions.
• Develop and execute clinical data review plans and provide timely scientific interpretation of emerging data to internal teams and governance committees.
• Work closely with Clinical Operations, Data Management, and Biostatistics to optimize clinical data collection, CRF design, EDC functionality, data quality, and overall study execution.

Scientific & Regulatory Leadership

• Author and/or review key technical and clinical documents, including clinical study protocols, investigator brochures, clinical study reports, annual reports, safety documents, and clinical sections of regulatory submissions.
• Partner with Regulatory Affairs to define global regulatory strategy and represent the clinical development perspective in interactions with health authorities, including discussions supporting registrational development and BLA/MAA submissions.
• Participate in and prepare presentations for DSMBs, Steering Committees, Scientific Advisory Boards, investigator meetings, and other internal and external scientific forums.
• Assist in the preparation of abstracts, manuscripts, posters, and scientific presentations.

Cross-Functional Collaboration

• Partner with Clinical Operations in the selection of investigators, clinical sites, and vendors (including CROs) and be accountable for the scientific execution of clinical protocols.
• Coordinate scientific activities across Regulatory Affairs, Translational Medicine, Clinical Operations, Pharmacovigilance, Biometrics, and other internal stakeholders to ensure efficient execution of clinical programs.
• Provide clinical leadership across cross-functional program teams, driving alignment and accountability around development priorities, key decisions, timelines, and program risks.

External Engagement

• Build productive relationships with external scientific experts, investigators, and key opinion leaders.
• Establish credibility as a clinical and scientific leader with investigators and KOLs and effectively communicate the scientific rationale, clinical data, and development strategy for assigned programs.

Leadership & Working Style

• Operate as a senior clinical development leader with the ability to set direction, influence decisions, challenge assumptions, and drive alignment across multidisciplinary teams.
• Provide mentorship and clinical guidance to Clinical Development team members and contribute to building the capabilities of the broader organization.
• Work independently while contributing effectively within a collaborative, interdisciplinary team environment.
• Maintain flexibility to meet deadlines and respond effectively to changing priorities in a fast-paced development environment.

The ideal candidate is a physician-scientist and seasoned oncology drug developer who has owned a clinical program through late-stage development, is credible with investigators and health authorities, and thrives in an entrepreneurial, hands-on biotech setting.

• MD or international equivalent with 8+ years of biotechnology and/or pharmaceutical industry clinical development experience, including significant experience in sponsor-side oncology drug development.
• Oncology drug development experience is required. Prior experience in immuno-oncology, immunotherapy, checkpoint inhibitors, or other immune-based therapies is strongly preferred.
• Experience leading global clinical development programs from early-phase development through late-stage and registrational studies, including Phase 3 trials and contributions to global regulatory submissions (e.g., BLA, NDA, or MAA).
• Experience taking ownership of a clinical development program from study design through database lock, clinical study report, regulatory submission, and health authority interactions, rather than isolated experience across multiple studies.
• Demonstrated ability to lead cross-functional clinical development teams and influence program strategy and decision making at the senior leadership level.
• Experience representing clinical programs with investigators, KOLs, health authorities, governance committees, and/or executive leadership.
• Broad and solid understanding of drug development, including preclinical research, clinical operations, regulatory affairs, pharmacovigilance, biometrics (biostatistics and data management), and drug supply.
• Hands-on experience reviewing, interpreting, and analyzing clinical trial data with accountability for the scientific quality, integrity, and communication of study results.
• Ability to understand, interpret, and communicate complex clinical information, literature, competitive intelligence, and evolving treatment paradigms to support robust clinical development strategies.
• Excellent written and verbal communication skills with the ability to influence cross-functional teams and effectively communicate complex scientific concepts.
• Ability to make sound medical decisions in ambiguous situations, reconcile differing scientific opinions, and communicate evidence-based recommendations to senior leadership and cross-functional stakeholders.
• Critical traits for success include strategic thinking, scientific curiosity, strong analytical skills, decisiveness, sound medical judgment, attention to detail, and the ability to influence without direct authority.
• Ability to work independently, prioritize effectively, and manage multiple complex initiatives simultaneously.
• Self-motivated, detail-oriented, and comfortable working in an entrepreneurial, fast-paced biotechnology environment where a hands-on approach is expected.
• Medical, Dental & Vision Coverage – Competitive options for both US & UK employees
• Flexible Spending Accounts – For healthcare and dependent care expenses (US)
• Flexible Vacation Plan – We believe time away leads to better thinking and innovation.
• Care.com Memberships – Support for family care (US)
• Education Assistance Program – Invest in your learning and development (US)
• 401(k) Match
• Employee Stock Purchase Plan
• Employee Assistance Program (EAP) – Resources for mental health, well-being, and life support
• Reward & Recognition Program – Celebrate contributions that move the mission forward