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Fortvita Biologics · 11 hours ago

Director of Clinical Science

Palo Alto, CA

Full-time

Hybrid

Director/Executive

8+ years exp

Fortvita Biologics is looking for a dynamic and experienced Director of Clinical Science. This role is responsible for leading and supporting the design, execution, and data interpretation of clinical studies in oncology while collaborating with various cross-functional teams to ensure successful clinical plans and execution.

Biotechnology

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

Qualification

Oncology clinical developmentClinical trial methodologyGCP/ICH guidelinesClinical data interpretationSafety surveillanceBiomarkers experienceLeadership skillsCommunication skillsProblem-solving mindsetCollaboration skills

Required

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