Job Description

Fortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering, with platforms that span antibody-drug conjugates (ADCs), bispecifics, and multispecifics. Our pipeline targets oncology, immunology, and neurodegenerative diseases and is supported by a team of over 100 across research, development, regulatory, and operational functions. With a global clinical presence and an emphasis on thoughtful design and agile execution, Fortvita is working to translate next-generation biologics from concept to clinic.

Summary

Fortvita is seeking an experienced and driven Medical Director to lead and support the clinical development of our oncology pipeline programs from Ph1-Ph3. This individual will play several key parts in the clinical development program, helping lead the design, planning, execution, and interpretation of clinical trials and contributing to multiple regulatory submissions and interactions.

The ideal candidate will bring a deep understanding of solid tumor malignancies, ideally with some heme/myeloma background. Experience in both early and late-stage clinical development and a proven ability to work cross-functionally, in a fast-paced biotech environment are essential.

Responsibilities

Clinical Development Strategy

• Provide strategic input into the design and execution of oncology clinical development plans and clinical trials across myriad 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 KOL’s, professional organizations, and advocacy groups.

Trial Execution

• Provide medical oversight for ongoing clinical studies, including real-time review of safety and efficacy data and sponsor-side leadership of key committees (SRC’s, Steering Committees, etc.).
• Subject matter leadership of the creation and revision of study protocols, investigator brochures, and other key documents.
• Collaborate with Clinical Operations, Biostatistics, Regulatory, and other functional teams to ensure timely and high-quality trial conduct.

Data Analysis and Reporting

• Contribute to statistical analysis plans and interpretation of clinical trial results.
• Lead the drafting and review of clinical study reports, abstracts/congress presentations, and manuscript submissions.

Regulatory and Safety

• Partner 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 (e.g., IND, NDA, BLA).
• Work with Safety/Pharmacovigilance to monitor and assess safety data, support DMCs, respond to safety-related issues, and prepare requisite safety updates (eg. DSUR).

Scientific Communication

• Represent the company at public and private scientific and medical meetings, including presenting clinical data to external stakeholders.
• Provide medical input on business development activities and other external facing documents and interactions.

Qualifications

Required

• MD or MD/PhD required, with board certification or eligibility in oncology, and/or hematology, or a related sub-specialty preferred.
• Minimum of 5–8 years of industry experience in oncology drug development, including comprehensive medical monitoring experience and functional leadership of early and late-stage clinical trials.
• Demonstrated leadership in the execution of global oncology clinical development plans and deep familiarity with regulatory pathways and submissions.
• Strong knowledge of GCP, ICH guidelines, and applicable regulatory requirements.
• Post-graduate direct experience in the care of cancer patients preferred.
• Excellent written and verbal communication skills; strong scientific writing ability.
• Proven ability to work in cross-functional teams and in a fast-paced, collaborative biotech environment.

Preferred

• Experience 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 medicine.

Compensation and Benefits Include:

• Competitive base salary, bonus, and equity for all employees.
• Salary Range: $200,000 to $220,000 -This reflects the company’s pay scale for the role. Actual compensation may vary depending on factors such as location, skills, experience, and performance.
• 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.

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 hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

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