Role Summary
Executive Medical Director, Clinical Development-Oncology. Lead execution of key bispecific antibody programs in solid tumors, driving program strategy and scientific/medical rigor across functions from early development through late-phase/registrational trials. Hybrid role with on-site requirement; based in San Diego or Pasadena, CA.
Responsibilities
- Provides strategic leadership and medical expertise for clinical development of bispecific antibodies in oncology
- Drives program strategy for complex individual and combination programs, delivering comprehensive Development Plans
- Defines global clinical development strategies, anticipating regulatory pathways, competitive dynamics, and scientific inflection points
- Partners with Biostatistics, Regulatory Affairs, Clinical Operations, Safety, Translational Science, and other functions to ensure cohesive program execution
- Drives integrated decision-making by aligning stakeholders
- Designs, plans, and oversees the execution of clinical studies from early through late-stage development
- Works with Clinical Operations to provide medical expertise and execute trials on time and with high quality
- Coordinates ongoing review of clinical data, data analyses, and data interpretation; supports data cleaning and interpretation
- Partners with Pharmacovigilance to provide internal safety monitoring for trials
- Delivers clinical protocols and key clinical elements of documents including investigator brochures, DSURs, IND modules, and regulatory correspondence
- Develops and maintains relationships with key opinion leaders and trial investigators
- Represent the company as a senior clinical leader in scientific, regulatory, and medical forums
- Ensure compliance with regulatory standards and guidelines; adhere to department and company policies
- Provide oversight, mentorship, and direction to direct and indirect reports
- Perform other duties as required
Qualifications
- Medical degree (MD, DO or equivalent), board certification in hematology and/or oncology
- Minimum 8 years of directly relevant pharmaceutical industry experience in clinical development, with at least 5 years in oncology/immune-oncology
- Experience including data review, safety monitoring, protocol development, data analyses, interpretation, and publications
- Experience working on cross-functional clinical trial teams and liaising with investigators
- Prior people management experience
- The company may consider internal experience in lieu of some education or experience requirements
Skills
- Strong initiative, organization, and attention to detail
- Excellent written and oral communication and interpersonal skills
- Ability to deliver concise, high-quality executive presentations
- Ability to manage others through coaching and supervision
- Ability to build effective cross-disciplinary relationships and manage multiple projects under pressure
- Strong analytical, assessment, and problem-solving skills
- Ability to analyze and interpret complex clinical data
- Expertise in data review, safety monitoring, protocol development, data analyses, and publications; experience with cross-functional clinical trial teams
- Experience across the full study life cycle; monoclonal antibody/immunotherapy clinical development and translational medicine/early-phase trials preferred
Education
- Medical degree required; board certification in hematology and/or oncology
Additional Requirements
- Occasional travel may be required, including travel between Pasadena and San Diego offices
- Full-time on-site work; hybrid option with minimum 2 days on-site per week