Lead the preclinical science that carries a next-generation cell and gene therapy pipeline from candidate nomination to first-in-human.

Our client is a clinical-stage, global biotechnology company developing cell and gene therapies for hematological malignancies, solid tumors, and autoimmune disease. With a global research and development footprint and a rapidly advancing pipeline — including next-generation in vivo cell therapy programs — the organization is scaling its Early Drug Development function and is seeking a Head of Preclinical Development to build and lead its global preclinical organization.

This is a senior, externally visible scientific leadership role accountable for the full preclinical development program — in vitro pharmacology, in vivo pharmacology, and toxicology — across every pipeline compound, globally. It is a strategy-and-execution leadership seat, not a hands-off oversight role: the successful leader will set the organization's scientific standards and own IND strategy while staying close enough to the science to guide experimental design and data interpretation directly. This person serves as the internal scientific authority and the external face for preclinical science across regulatory, partnership, and publication contexts, and plays a critical role in transitioning assets from research into the clinic.

Essential Duties and Responsibilities

This list represents the major duties of the role and is not all-inclusive. The successful candidate may be asked to perform related duties beyond those described here.

Preclinical Strategy & Portfolio Leadership

• Define and execute the global preclinical development strategy across the entire pipeline, from candidate nomination through IND-enabling studies.

• Serve as the internal scientific authority on in vitro pharmacology, in vivo pharmacology, and toxicology — setting methodological standards, experimental design principles, and data interpretation frameworks.

• Contribute to portfolio decisions by providing rigorous preclinical risk assessments for new candidates, partnership assets, and lifecycle-management opportunities.

• Play a critical role in advancing assets from research into clinical development.

Modality Depth & Translational Science

• Lead preclinical science for novel modalities, including viral-vector–based in vivo CAR-T, ex vivo cell therapies, and gene-modified immune cell platforms, with a deep understanding of the distinct preclinical characterization requirements of each.

• Integrate preclinical datasets (PK, PD, safety, biodistribution) into coherent compound narratives that inform clinical development strategy and regulatory submissions.

• Drive dose selection and support clinical study design.

IND & Regulatory Leadership

• Own the preclinical component of IND applications — accountable for integrated pharmacology and toxicology summaries, study tabulations, and the Written Summary of nonclinical pharmacology and toxicology.

• Lead regulatory interactions with the FDA and global health authorities across modalities.

• Ensure programs are IND-ready and aligned with clinical development goals under aggressive timelines, without compromising scientific rigor.

CRO & External Partnerships

• Select, qualify, and oversee CRO partners for outsourced preclinical and GLP studies, including protocol development, study monitoring, and report review.

• Manage external research partnerships and embedded CRO personnel as an extension of the internal team.

Team Leadership & Culture

• Build, lead, and develop a high-performing, integrated preclinical team spanning in vitro pharmacology, in vivo pharmacology, and toxicology across multiple global sites.

• Set a culture of scientific excellence, objectivity, and regulatory integrity — where data are interpreted accurately regardless of program pressure and safety signals are escalated promptly and without bias.

• Mentor and develop team members at all levels; create individual development plans, provide regular feedback, and support career progression.

Qualifications

The requirements below are representative of the knowledge, skills, and abilities needed to perform this role successfully.

Required

• PhD in a related discipline.

• Significant, progressive experience in preclinical drug development and senior leadership experience with direct accountability for IND-enabling programs.

• Direct cell therapy / CAR-T development experience.

• Deep expertise in in vitro and in vivo pharmacology.

• Track record of successful IND submissions with clear accountability for the nonclinical pharmacology and toxicology sections, and experience leading regulatory interactions.

• Oncology and/or immunology background.

• Proven ability to lead, mentor, build, and scale high-performing scientific teams in a fast-paced biotech environment.

Preferred

• Gene therapy and viral vector experience (AAV, LVV, and related viral vector platforms).

• Experience with global regulatory submissions and leadership of multinational teams.

• Comfort balancing strategic leadership with hands-on execution across complex, concurrent programs.

Nice to Have

• Depth in GLP toxicology study design and oversight (repeat-dose NHP or rodent, safety pharmacology, genotoxicity) 

Compensation: Base Salary $325,000 - 380,000 + plus a performance-based annual bonus and equity / long-term incentive eligibility.

The compensation offered will be commensurate with experience, skills, qualifications, and other relevant factors.

About the Search

This search is being managed by Summit Strategic Search on behalf of our client. This is a full-time, permanent position where the successful candidate will be hired directly by the end client.

Equal Opportunity Commitment: Summit Strategic Search and our client are equal opportunity partners. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity or expression, sexual orientation, age, marital status, veteran status, or disability status.

Accommodations & Support: We are committed to providing reasonable accommodations for qualified individuals with disabilities during the application and interview process. If you require assistance, please contact us at [email protected]. We maintain a zero-tolerance policy for harassment and provide all employees with dedicated reporting channels to ensure a safe, professional work environment.

Selection & Onboarding: As this is a direct-hire role within a regulated industry, the end client's standard hiring protocols apply. This includes, but is not limited to, a comprehensive background check and drug screening prior to the start of employment. All hiring decisions are made solely by the end client.