Director of Clinical Science

Fortvita Biologics; Palo Alto (CA); Hybrid; USD 150,000 - 210,000; Full time

Job summary

A leading biotechnology firm in Palo Alto is seeking a dynamic Director of Clinical Science to lead oncology clinical studies. The role involves designing, executing, and interpreting clinical studies while collaborating with cross-functional teams. The ideal candidate will have a doctoral-level degree and over 8 years of clinical development experience, particularly in oncology. Competitive compensation and benefits offered, including equity and a retirement plan.

Benefits

Competitive base salary

401(k) retirement plan

Comprehensive medical, dental, and vision insurance

Generous paid time off policy

Qualifications

• Minimum 8+ years of industry experience in clinical development or clinical science, preferably within oncology.
• Strong understanding of clinical trial methodology, GCP/ICH guidelines, and regulatory requirements.
• Experience in working with CROs and external partners.

Responsibilities

• Lead clinical study design, protocol development, and amendments.
• Serve as clinical science lead on cross-functional study teams.
• Drive clinical review of study data including safety and efficacy.

Skills

Leadership in clinical study design

Oncology clinical development

Cross-functional team collaboration

Clinical data interpretation

Exceptional communication skills

Proactive problem-solving

Education

PhD, PharmD, MD, or Master's degree

Job description

Overview

Fortvita is looking for a dynamic and experienced Director of Clinical Science. The Director of Clinical Science is responsible for leading and supporting the design, execution, and data interpretation of clinical studies in oncology. This individual will play a key leadership role in shaping clinical development strategy and driving operational execution across one or more programs. The Director will partner cross-functionally with Clinical Operations, Translational Science, Regulatory, Biostatistics, and other key functions to ensure clinical plans are thoughtfully designed, executed with excellence, and aligned with program goals.

This role requires a proactive, detail-oriented clinical scientist with strong experience in oncology clinical development, a strategic mindset, and the ability to navigate a dynamic, fast-paced environment.

Responsibilities

• Lead or contribute to clinical study design, protocol development, and amendments, in collaboration with Medical Directors and cross-functional partners.
• Serve as the clinical science lead on cross-functional study teams and act as a key point of contact for study-related clinical questions.
• Author or review key clinical documents including protocols, investigator brochures, study reports, and regulatory filings (IND, CTA, BLA/NDA).
• Drive and participate in the ongoing clinical review of study data, including safety, efficacy, and biomarker endpoints, in collaboration with biostatistics, data management, and safety teams.
• Support safety surveillance activities, including participation in internal safety review meetings and analysis of safety trends.
• Collaborate with Clinical Operations to ensure proper study implementation and execution, including contributions to study start-up documents (ICFs, CRFs, lab manuals, etc.).
• Partner with CROs, site staff, and investigators to support protocol execution, resolve study-related issues, and ensure high-quality data collection.
• Provide clinical and scientific input into study-related materials including investigator meeting presentations, training decks, newsletters, and site communications.
• Participate in the development and review of abstracts, posters, presentations, and manuscripts, support submission to scientific conferences and publications.
• Maintain awareness of scientific and competitive landscape to inform study and program strategy.
• Contribute to the development of clinical strategies and long-term plans in alignment with program objectives.

Location: Onsite three days a week at our Palo Alto Office

Requirements

• Advanced scientific or clinical degrees (PhD, PharmD, MD, master’s degree or equivalent) required.
• Minimum 8+ years of industry experience in clinical development or clinical science, preferably within oncology; prior experience in early- or mid-stage development highly desirable.
• Demonstrated ability to lead and support cross-functional clinical study teams and successfully manage study execution.
• Strong understanding of clinical trial methodology, GCP/ICH guidelines, and regulatory requirements in the US and ex-US.
• Experience in clinical data interpretation, safety surveillance, and working with biomarkers or translational data in oncology.
• Exceptional written and verbal communication skills with the ability to articulate complex clinical and scientific concepts to diverse audiences.
• Proactive problem-solving mindset with ability to anticipate issues, develop contingency plans, and deliver high-quality work under tight timelines. Experience working with CROs, investigators, and other external partners in a collaborative and solution-oriented manner.
• Ability to thrive in a fast-paced, nimble environment with evolving priorities and limited infrastructure

Compensation and Benefits

• Competitive base salary, bonus, and equity for all employees.
• 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 [e-mail]. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.