Medical Director / Sr. Medical Director

Medical Director (Clinical Development) / Sr. Medical Director (Clinical Development) Job Type: Full-timeSalary$250K - $350KLocation: Palo Alto, CA (Hybrid - 2-3 days a week onsite) Candidates local to Pacific NW and other areas in CA will be considered based on the discretion of the hiring team. Company Summary: Global biopharma company based in the SF Bay Area focusing in advancing the oncology space through antibody discovery and development. Their pipeline spans ADCs, bispecifics, and multispecific therapies that targets oncology, immunology, and neurodegenerative diseases. As they continue to grow, they hope to be at the forefront of next gen biologics innovation.The Opportunity: Join as an experienced and driven MD to lead and support the clinical development of their Ph1-3 oncology pipeline. In addition, this person will be a key leader in study design, planning, execution and will contribute greatly to regulatory interactions.Responsibilities:Clinical Development StrategyProvide strategic input into the design and execution clin dev plans and trialsContribute with geostrategy, site identification & selection, investigator engagement, and KOL/professional organization/advocacy group engagementAct as the clinical expert on product teams in line with overall program goalsTrial ExecutionProvide medical oversight for ongoing clinical studiesSME role in creation and revision of study protocols, investigator brochures, and other key documentsContribute to drafting and review of clinical study reports, abstracts/congress presentations, and manuscript submissionsCross Functional CollaborationWork with other functional teams to ensure timely and high quality trial conductPartner with Regulatory Affairs to formulate regulatory strategy - prepare for and participate in regulatory interactions (e.g., FDA, EMA, PMDA), and produce high quality regulatory submissions.Collaborate with Safety/Pharmacovigilance to monitor and assess safety data, support DMCs, respond to safety-related issues, and prepare requisite safety updates (eg. DSUR).QualificationsMD or MD/PhD required with Board Certification or Eligibility in oncology and/or hematologyMinimum of 3 years of industry experience in oncology drug developmentPrevious exp executing global oncology clin dev plans and familiarity with regulatory pathways & submissionsStrong knowledge of GCP-ICH guidelinesPreferredExperience with novel therapeutic modalities (e.g., immuno-oncology, ADCs, cell therapy).Prior direct involvement in successful regulatory filings (e.g., IND, NDA, BLA).Familiarity with biomarker-driven drug development and translational medicineBenefits:Competitive base salary, bonus, and equity for all employees.401(k) retirement plan with employer matching contributions.Comprehensive medical, dental, and vision insurance.Generous paid time off policy, including company holidays and floating holidays.

Created: 2025-09-26