Note: The job is a remote job and is open to candidates in USA. Fortvita Biologics is a biopharmaceutical company advancing biologics and developing therapies in oncology and other critical disease areas. The Medical Director will lead and support oncology clinical development programs from Phase I through Phase III, overseeing trial design, execution, medical monitoring, data interpretation, regulatory submissions, and cross-functional collaboration.
Responsibilities
- Provide strategic input into the design and execution of oncology clinical development plans and clinical trials across multiple disease states
- Serve as the clinical expert on cross-functional product teams, contributing to the execution of overall program goals
- Support geostrategy, site identification and selection, investigator engagement, and relationships with KOLs, professional organizations, and advocacy groups
- Contribute to indication selection, protocol optimization, and development planning activities
- Serve as Medical Monitor for ongoing clinical studies, providing real-time medical oversight and review of patient safety and efficacy data
- Review eligibility criteria, protocol deviations, safety signals, serious adverse events (SAEs), and dose escalation decisions
- Provide sponsor-side leadership for key governance committees including SRCs, DMCs, and Steering Committees
- Lead the development and revision of study protocols, investigator brochures, informed consent forms, and other key clinical documents
- Collaborate with Clinical Operations, Biostatistics, Regulatory, Pharmacovigilance, and other functions to ensure high-quality trial execution
- Contribute to statistical analysis plans and interpretation of clinical trial results
- Lead drafting and review of clinical study reports, abstracts, congress presentations, publications, and manuscripts
- Analyze emerging clinical and scientific data to support strategic program decisions
- Partner with Regulatory Affairs to develop regulatory strategy and support interactions with FDA, EMA, PMDA, and other health authorities
- Contribute to regulatory submissions including INDs, NDAs, BLAs, briefing documents, and responses to regulatory inquiries
- Work closely with Safety/Pharmacovigilance to monitor and assess safety data, support DMC activities, and prepare safety updates including DSURs
- Ensure compliance with GCP, ICH guidelines, and applicable regulatory requirements
- Represent the company at scientific and medical meetings, advisory boards, investigator meetings, and congresses
- Present clinical data to external stakeholders and collaborators
- Provide medical input into business development activities and external-facing scientific materials
- Other duties as assigned
Skills
- • MD or MD/PhD required
- • Minimum of 10+ years of industry experience in oncology drug development
- • Comprehensive medical monitoring experience across early and late-stage clinical trials
- • Demonstrated leadership in global oncology clinical development programs
- • Strong knowledge of GCP, ICH guidelines, and global regulatory requirements
- • Excellent written and verbal communication skills with strong scientific writing capabilities
- • Proven ability to work effectively in cross-functional teams within a fast-paced biotech environment
- • Strong clinical and scientific judgment
- • Expertise in medical monitoring and oncology clinical development
- • Excellent leadership and stakeholder management capabilities
- • Strong analytical and problem-solving skills
- • Ability to thrive in a fast-paced and evolving biotech environment
- • Exceptional communication and presentation skills
- • Post-graduate direct experience caring for cancer patients preferred
- • Board certification or eligibility in oncology, hematology, or related subspecialty preferred
- • Experience with novel therapeutic modalities including immuno-oncology, ADCs, bispecifics, or cell therapies
- • Prior involvement in successful IND, NDA, or BLA submissions
- • Familiarity with biomarker-driven drug development and translational medicine
- • Experience supporting global clinical development programs
Benefits
- Remote (U.S.-based)
- Preference is San Francisco Bay Area - Hybrid (Palo Alto Office)
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