Role Overview
Executive Director, Clinical Development will provide strategic, scientific, and medical leadership for the Non-Hodgkin Lymphoma (NHL) clinical development program. Serves as the clinical lead, accountable for lymphoma strategy and an integrated clinical development strategy across early- and, as appropriate, later-stage development.
Key Responsibilities
- Serve as clinical lead for the NHL program across the development lifecycle.
- Develop and execute an integrated clinical development plan (indication strategy, patient selection, endpoints, dose rationale/selection, biomarker strategy, safety monitoring, evidence plan).
- Lead design/execution/monitoring/interpretation/reporting of first-in-human, dose-escalation/expansion, proof-of-concept, and other early studies.
- Lead or contribute to late-stage/pivotal strategy, protocol design, data interpretation, and registration-enabling planning.
- Provide clinical leadership for clinical deliverables (protocols, clinical study reports, investigator brochures, regulatory briefing documents, INDs, health authority packages, publications/abstracts/presentations).
- Supervise NHL clinical development medical director(s) and clinical science team.
- Partner cross-functionally (translational, biomarkers, pharmacology, nonclinical, regulatory, safety/pharmacovigilance, biostatistics, data management, clinical ops, project management, CMC, commercial).
- Oversee study conduct (medical monitoring, eligibility review, safety review, dose-escalation decisions, data review).
- Engage investigators/sites/advisors; represent program in forums and regulatory interactions.
- Identify program risks and mitigation; champion patient focus, scientific rigor, collaboration, urgency, ethics, compliance, and operational excellence.
Requirements
- MD, MD-PhD, or equivalent; board certification in hematology or oncology required.
- 6+ years clinical development in biopharma/academic medicine; substantial hematologic malignancies experience; NHL experience strongly preferred.
- Experience leading early clinical development (FIH, dose escalation/expansion, dose selection, integrated safety monitoring, data review, PoC).
- Cell therapy/immuno-oncology experience (CAR-T, in vivo cell therapy, T-cell engagers, bispecific antibodies) highly desirable.
- IND submissions and pre-IND/IND meetings/regulatory briefing packages/health authority interactions highly desirable.
- Strong oncology clinical trial design, safety monitoring, benefit-risk, dose optimization, biomarker strategy, and decision-making.
- Experience in matrixed global cross-functional teams preferred.
- Strong communication and stakeholder influencing/collaboration skills.
- Ability to travel 15β20%.
Benefits
Base pay: $338,656β$444,486; performance bonus and/or equity (eligible roles). Medical/dental/vision; 401(k) match; 8 weeks paid parental leave after 3 months; paid time off (vacation/personal/sick/floating holidays/11 company holidays); additional voluntary benefits (e.g., HSA/FSA, life/AD&D, short-/long-term disability, legal assistance, supplemental insurance).
Application Instructions
Applicants must be authorized to work in the United States (E-Verify; Form I-9 upon selection).