Executive Director, Early Clinical Development, NHL Program Lead
- 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.
- 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 clinical leadership for protocols, clinical study reports, investigator brochures, regulatory briefing documents, IND submissions, health authority meeting packages, publications, abstracts, presentations, and other key clinical deliverables.
- Supervision of the NHL clinical development medical director(s) and clinical science team.
- Partner closely with translational science, biomarker, pharmacology, nonclinical, regulatory, safety/pharmacovigilance, biostatistics, data management, clinical operations, project management, CMC, and commercial colleagues to ensure integrated and executable development plans.
- Provide medical and scientific oversight for study conduct, including medical monitoring, eligibility review, safety review, dose-escalation decision-making, data review, 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.
- Engage with investigators, academic experts, cooperative groups, study sites, and external advisors to support high-quality execution, scientific exchange, enrollment strategy, and program visibility.
- Represent the NHL program in internal governance forums, senior leadership reviews, external scientific meetings, regulatory interactions, and business development or partnership discussions as needed.
- Identify key program risks and mitigation strategies, including clinical, regulatory, operational, safety, competitive, and translational risks.
- Champion a culture of patient focus, scientific rigor, collaboration, urgency, ethics, compliance, and operational excellence.
- MD, MD-PhD, or equivalent medical degree required; board certification in hematology or oncology is required.
- Minimum of 6 years of clinical development experience in the biopharmaceutical industry and/or academic medicine, with substantial experience in hematologic malignancies; experience in Non-Hodgkin Lymphoma is strongly preferred.
- 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.
- Experience with cell therapy, CAR-T, in vivo cell therapy, T-cell engagers, bispecific antibodies, or other immuno-oncology modalities is highly desirable.
- Experience contributing to IND submissions, pre-IND or IND meetings, regulatory briefing packages, and health authority interactions is highly desirable.
- Strong understanding of hematology/oncology clinical trial design, response assessment, safety monitoring, benefit-risk evaluation, dose optimization, biomarker strategy, and clinical development decision-making.
- Experience leading or significantly contributing to cross-functional development teams in a matrixed, global environment is preferred.
- 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/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 15-20% of the time.
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