Our client is a clinical-stage biotechnology company advancing innovative cellular immunotherapy approaches for the treatment of cancer and other serious diseases. Their pipeline includes multiple next-generation cell therapy modalities, including CAR-T, CAR-NK, and related engineered immune cell platforms, with programs spanning early clinical development.

• Requirement: Active MD, MD/PhD, or international equivalent with board eligibility/certification in Oncology/Hematology or related specialty
• Location: Remote (US-based)

Position Overview

The Executive Director, Early Clinical Development will provide strategic and scientific leadership for early-stage clinical programs across hematologic malignancies and oncology indications. This individual will be responsible for shaping and executing clinical development strategies from first-in-human through proof-of-concept studies, including trial design, clinical execution, data interpretation, and regulatory interactions.

This role requires a physician leader with deep expertise in oncology drug development, strong scientific judgment, and experience navigating complex clinical and regulatory environments. The successful candidate will partner closely with cross-functional teams and external stakeholders to advance innovative cell therapy programs while maintaining a strong focus on patient safety and clinical impact.

The Executive Director will serve as a key member of the clinical development organization, providing both strategic leadership and hands-on guidance across multiple development programs.

Key Responsibilities

Clinical Development Strategy & Execution

• Lead clinical development activities for early-stage oncology programs from IND-enabling stages through Phase 1/2 development.
• Develop and execute clinical strategies, including study design, protocol development, clinical endpoints, biomarker integration, translational medicine plans, and data interpretation.
• Provide clinical leadership in evaluating emerging assets, preclinical data packages, and development opportunities.
• Drive clinical decision-making and present program recommendations to senior leadership and governance committees.
• Integrate clinical, scientific, translational, and operational considerations into development strategies to maximize program success.
• Contribute to publication planning, scientific communications, and presentation of clinical data.

Regulatory Leadership

• Lead or contribute to IND submissions, protocol amendments, investigator brochures, and other regulatory documentation.
• Serve as a key clinical representative during interactions with regulatory authorities.
• Support responses to regulatory agency questions and requests.
• Ensure adherence to GCP, patient safety standards, and applicable global regulatory requirements.

Cross-Functional Collaboration

• Partner closely with Clinical Operations, Regulatory Affairs, Translational Medicine, Biometrics, Pharmacovigilance, Manufacturing, and Research teams to ensure successful program execution.
• Collaborate with investigators, key opinion leaders, academic partners, and external development organizations.
• Represent clinical development activities in internal governance forums and external scientific interactions.
• Foster strong cross-functional alignment to support timely and effective program delivery.

Leadership & Talent Development

• Provide leadership, mentorship, and development for clinical team members, including physicians and clinical scientists.
• Effectively lead within a highly matrixed environment, fostering collaboration and driving alignment across functions.
• Anticipate and proactively address program risks, challenges, and resource needs.
• Contribute to strategic planning, portfolio discussions, business development evaluations, and due diligence activities as needed.

Qualifications

Required

• MD or MD/PhD (or international equivalent).
• Board certification or equivalent training in Hematology, Medical Oncology, or a related oncology specialty.
• Significant clinical development experience within biotechnology, pharmaceutical, or academic settings, including leadership responsibility for oncology programs.
• Demonstrated experience leading early-stage clinical development programs from first-in-human through proof-of-concept studies.
• Prior experience with IND submissions and regulatory authority interactions.
• Strong understanding of clinical trial design, translational medicine, biomarker strategies, and regulatory requirements.
• Proven ability to lead cross-functional teams and influence stakeholders within a matrixed environment.
• Excellent communication, presentation, and scientific writing skills.

Preferred

• Direct experience in cell therapy development, including CAR-T, CAR-NK, TCR-T, tumor-infiltrating lymphocyte (TIL), or other engineered immune cell therapy platforms.
• Experience across hematologic malignancies; exposure to solid tumor development is a plus.
• Experience supporting global clinical development programs.
• Prior involvement in BLA, MAA, or other late-stage regulatory submissions.
• Demonstrated success working in fast-paced, innovative biotechnology environments.

Compensation & Benefits:

• Annual Base Salary: $350,000 – $400,000
• Annual Performance Bonus
• New Hire Equity
• Long-Term Incentive Program
• Immediate 401K match vesting
• Comprehensive Total Rewards

*Compensation will be commensurate with experience, qualifications, and overall fit for the position.

Confidential Search Notice:

Due to the strategic nature of this opportunity, certain details regarding the organization, pipeline assets, and development programs will be shared during the interview process with qualified candidates.

About the Search

This search is being managed by Summit Strategic Search on behalf of a confidential biotechnology client. This is a full-time, permanent opportunity with direct employment by the hiring organization.

Equal Opportunity Commitment

Summit Strategic Search and our client are equal opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law.

Accommodations & Support

We are committed to providing reasonable accommodations to qualified individuals with disabilities throughout the application, interview, and hiring process. If you require accommodation or assistance, please contact us at [email protected].

Summit Strategic Search maintains a professional and respectful recruiting process and is committed to providing an environment free from discrimination, harassment, and retaliation.

Selection & Onboarding

This is a direct-hire opportunity with our client. As part of the hiring process, the selected candidate will be subject to the client's standard pre-employment requirements, which may include background verification, reference checks, and other screening procedures consistent with applicable laws and regulations. All hiring decisions are made solely by the end client.