provide clinical oversight and medical monitoring to one or more clinical trials
lead project teams to design and implement clinical studies
write protocols, investigator brochures, clinical study reports, and review clinical trial documents
conduct investigator meetings and lead site initiation visits with clinical trial investigators
implement and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
translate findings from research and nonclinical studies into clinical development opportunities
interact with clinical investigators and thought leaders
work with internal regulatory affairs team to ensure compliance with external guidelines
provide clinical expertise and input for regulatory filings (i.e., BLA, MAA)
collaborate with external stakeholders and internal stakeholders in a team environment

MD/DO
4+ years of clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia
Board certification/specialization in hematology/oncology (preferred)
experience managing phase 1-3 trials (preferred)
Drug development experience within industry or as a clinical investigator/physician scientist in academia (preferred)
Cell therapy, solid tumor and/or hematological malignancy experience (preferred)
demonstrated clinical development strategist with experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies (preferred)
Strategic leadership and tactical skills, excellent initiative and judgment (preferred)
demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators (preferred)
demonstrated ability to work well in teams in a cross-functional manner (preferred)
ability to think critically, and demonstrated troubleshooting and problem-solving skills (preferred)
self-motivated and willing to accept responsibilities outside of initial job description (preferred)
comfortable in a dynamic small company environment with minimal direction and able to adjust workload based upon changing priorities (preferred)

discretionary annual bonus
discretionary stock-based long-term incentives (eligibility may vary based on role)
paid time off
company-sponsored medical plans
company-sponsored dental plans
company-sponsored vision plans
company-sponsored life insurance plans

Director, Clinical Development – MD

Key skills