Sr. Dir, Clinical Development Oncology

Fortvita Biologics; United States; Hybrid; USD 230,000 - 290,000; Full time

Job summary

Fortvita Biologics is seeking an experienced Medical Director to lead oncology clinical development from Phase I through III. This role designs, monitors, and interprets trials while guiding cross-functional teams in a fast-paced biotech environment.

The ideal candidate will have a deep understanding of solid tumors, strong medical monitoring expertise, and a track record of global program leadership with regulatory interactions in the US and abroad.

Qualifications

• MD or MD/PhD required.
• 10+ years of oncology drug development experience.
• Comprehensive medical monitoring across early and late-stage trials.
• Global oncology program leadership experience.
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
• Excellent written and verbal communication; solid scientific writing.
• Ability to work across cross-functional teams in a fast-paced biotech.

Responsibilities

• Provide strategic input into design and execution of oncology development plans and trials.
• Serve as clinical expert on cross-functional product teams and program goals.
• Support geostrategy, site identification, investigator engagement, and KOL relationships.
• Lead development and revision of protocols, IBs, ICFs, and other documents.
• Collaborate with Regulatory, Safety, Biostatistics, and Clinical Ops to ensure trial quality.

Skills

MD or MD/PhD

Oncology drug development

Medical monitoring

Leadership

Regulatory knowledge

Scientific writing

Cross-functional collaboration

Education

MD or MD/PhD

Job description

Medical Director, Clinical Development Oncology

Remote (U.S.-based) - CA, CO, CT, FL, IL, IN, MA, MD, MN, NH, NJ, NY, NC, PA, RI, TX, UT, VA, WA

Preference is San Francisco Bay Area - Hybrid (Palo Alto Office)

Travel up to 25% required

ABOUT THE COMPANY

Fortvita Biologics is a San Francisco Bay Area–based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs. Building on our foundation in oncology, we are expanding into cardiovascular and metabolic diseases, immunology, and ophthalmology, applying our scientific rigor and platform capabilities to areas of growing global health burden. Our expertise covers antibody discovery and engineering, including monoclonal, bispecific, and polyspecific antibodies, as well as antibody-drug conjugates, all supported by development strategies rooted in thoughtful design and agile execution.

Our clinical development footprint covers the U.S., Australia, and key regions across APAC and Europe, including the EU, UK, South Korea, and Japan. With more than 100 professionals across research, development, regulatory, and operations, we bring deep expertise and a global perspective to every program. Guided by our mission to transform research breakthroughs into therapeutic excellence and driven by our vision to improve lives through scientific innovation, we are committed to delivering meaningful impact for patients around the world.

POSITION SUMMARY

Fortvita is seeking an experienced and driven Medical Director to lead and support the clinical development of our oncology pipeline programs from Phase I through Phase III. This individual will play a key role in the clinical development program, helping lead the design, planning, execution, medical monitoring, and interpretation of clinical trials while contributing to multiple regulatory submissions and interactions.

The ideal candidate will bring a deep understanding of solid tumor malignancies, ideally with additional hematology/myeloma experience. Experience across both early and late-stage clinical development, combined with strong medical monitoring expertise and the ability to work cross-functionally in a fast-paced biotech environment, is essential.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

Clinical Development Strategy

• 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

Medical Monitoring & Trial Execution

• 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

Data Analysis & Scientific Reporting

• 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

Regulatory & Safety

• 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

Scientific Communication

• 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

REQUIRED QUALIFICATIONS

• 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
• Post-graduate direct experience caring for cancer patients preferred
• 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

PREFERRED QUALIFICATIONS

• 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

COMPETENCIES/CORE SKILLS

• 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

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at [e-mail]. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.