Executive Medical Director, NHL Lead at Summit Strategic Search in Somerville, New Jersey, United States

Job description

• Lead the clinical development strategy for a novel Lymphoma program, from first-in-human studies through proof-of-concept and toward potential registration.
• Our client is a global biotechnology company dedicated to treating and one day curing life-threatening diseases. The company is advancing the next generation of cell therapy (CAR-T) through innovative platforms.
• Our client is seeking an Executive Director, Clinical Development to serve as the clinical lead for its Non-Hodgkin Lymphoma program within the Clinical Development organization. This individual will provide strategic, scientific, and medical leadership for the program, accountable for shaping the lymphoma strategy and executing an integrated clinical development plan across early-stage and, as appropriate, later-stage development. The role spans first-in-human, dose-escalation, dose-expansion, and proof-of-concept studies, supporting IND submissions and regulatory interactions while integrating translational, biomarker, pharmacology, and safety data.
• Ultimately, this leader will drive the generation of high-quality clinical data to support benefit-risk assessment, differentiation, and potential registration. The successful candidate will bring deep hematology and oncology expertise, strong scientific judgment, and the ability to lead effectively in a fast-paced, highly matrixed environment.

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.
• Program & Clinical Strategy Leadership
• Serve as the clinical lead for the Non-Hodgkin Lymphoma program, providing strategic, scientific, and medical leadership across the development lifecycle.
• Develop and execute the integrated clinical development plan, including indication strategy, patient population selection, endpoint strategy, dose-selection rationale, biomarker strategy, safety monitoring approach, and evidence-generation plan.
• Represent the program in internal governance forums, senior leadership reviews, external scientific meetings, regulatory interactions, and partnership discussions as needed.
• Study Design & Execution
• Lead the design, execution, monitoring, interpretation, and reporting of first-in-human, dose-escalation, dose-expansion, proof-of-concept, and other early clinical studies.
• Lead or contribute to late-stage clinical development activities when appropriate, including pivotal study strategy, protocol design, data interpretation, and registration-enabling planning.
• Provide medical and scientific oversight for study conduct, including medical monitoring, eligibility review, safety review, dose-escalation decision-making, and interpretation of emerging clinical data.
• Ensure early development plans reflect contemporary regulatory expectations for oncology drug development, including robust dose optimization, PK/PD integration, biomarker-informed decision-making, and clear benefit-risk assessment.
• Regulatory & Scientific Deliverables
• Provide clinical leadership for protocols, clinical study reports, investigator brochures, regulatory briefing documents, IND submissions, health authority meeting packages, publications, abstracts, and presentations.
• Identify key program risks and mitigation strategies, including clinical, regulatory, operational, safety, competitive, and translational risks.
• Cross-Functional & External Collaboration
• Partner closely with translational science, biomarker, pharmacology, nonclinical, regulatory, safety and pharmacovigilance, biostatistics, data management, clinical operations, project management, CMC, and commercial colleagues to ensure integrated and executable development plans.
• Engage with investigators, academic experts, cooperative groups, study sites, and external advisors to support high-quality execution, scientific exchange, enrollment strategy, and program visibility.
• Team Leadership
• Provide leadership and supervision to clinical development medical directors and clinical science staff supporting the program.
• Champion a culture of patient focus, scientific rigor, collaboration, urgency, ethics, compliance, and operational excellence.

Requirements

• The requirements below are representative of the knowledge, skills, and abilities needed to perform this role successfully.
• Required
• MD, MD-PhD, or equivalent medical degree; board certification in hematology or oncology.
• Minimum of 6 years of clinical development experience in the biopharmaceutical industry and/or academic medicine, with substantial experience in hematologic malignancies.
• Demonstrated experience designing and leading early clinical development programs, including first-in-human studies, dose escalation, dose expansion, dose selection, integrated safety monitoring, clinical data review, and proof-of-concept generation.
• Strong understanding of hematology and oncology clinical trial design, response assessment, safety monitoring, benefit-risk evaluation, dose optimization, biomarker strategy, and clinical development decision-making.
• Ability to translate complex medical, scientific, translational, regulatory, and competitive information into clear clinical development strategies and actionable plans.
• Excellent written and verbal communication skills, including experience developing clinical and regulatory documents, presenting to senior leaders, and engaging external experts and investigators.
• Strong collaboration, influencing, conflict-management, negotiation, and decision-making skills, with the ability to align stakeholders across functions, geographies, and levels of the organization.
• Demonstrated ability to anticipate and integrate needs from clinical operations, regulatory, safety and pharmacovigilance, biometrics, translational science, project management, CMC, and other development functions.
• Track record of delivering results in a fast-paced environment, with the ability to operate strategically while contributing hands-on when needed.
• Commitment to the highest standards of quality, ethics, compliance, patient safety, and professional conduct.
• Ability to travel up to 15% to 20% of the time.
• Experience in Non-Hodgkin Lymphoma.
• Experience with cell therapy, CAR-T, in vivo cell therapy, T-cell engagers, bispecific antibodies, or other immuno-oncology modalities.
• Experience contributing to IND submissions, pre-IND or IND meetings, regulatory briefing packages, and health authority interactions.
• Experience leading or significantly contributing to cross-functional development teams in a matrixed, global environment.

Skills

Required

• Clinical development
• Hematology and oncology
• Clinical trial design
• Safety monitoring
• Benefit-risk evaluation
• Dose optimization
• Biomarker strategy
• Regulatory documents
• Communication
• Collaboration
• Influencing
• Conflict management

Preferred

• Non-Hodgkin Lymphoma