EXECUTIVE DIRECTOR, CLINICAL DEVELOPMENT

Sutro Biopharma•South San Francisco, CA

3d•$30,000 - $354,000

About The Position

Sutro Biopharma is seeking an Executive Director, Clinical Development to serve as a thought partner to the VP, Clinical Development in shaping clinical strategy for its oncology portfolio. The physician will work with global study leads to develop clinical strategies, strengthen safety assessment, and support global clinical program execution. The role calls for a physician-scientist with substantial oncology expertise and clinical development experience, particularly in early development, safety, and leading studies. The successful candidate will build trusted investigator relationships and translate clinical evidence into clear recommendations. The position partners with senior clinical leadership and cross-functional teams to evaluate portfolio opportunities and risks, shape development plans, support clinical studies and regulatory communications, and provide safety oversight. It also involves investigator engagement, scientific advisory activities, mentoring colleagues, and contributing to consistent practices that promote patient safety, scientific rigor, data integrity, and quality. Domestic and international travel is required as needed.

Requirements

MD or MD/PhD required, with substantial experience in oncology clinical development.
Approximately 10 or more years of relevant clinical research and drug development experience, including substantial clinical development experience in the biotechnology or pharmaceutical industry.
Strong clinical safety background, including medical monitoring, assessment of adverse events and emerging safety signals, benefit-risk evaluation, and collaboration with Pharmacovigilance.
Prior experience leading interventional clinical studies and direct experience with global trials involving investigators and teams across multiple countries.
Deep knowledge of early clinical development, including first-in-human studies, dose escalation, dose optimization, and expansion cohorts.
Ability to partner effectively with senior clinical leaders and global study leads, influence across functions, and translate complex data into sound clinical recommendations.
Experience contributing to regulatory documents and health authority interactions, with working knowledge of GCP and applicable global clinical trial requirements.
Strong scientific communication and relationship-building skills, including engagement with investigators and external experts.
Willingness and ability to travel domestically and internationally.

Nice To Haves

Board certification or eligibility in medical oncology or hematology/oncology.
Experience in solid tumors and antibody-drug conjugate development.
Experience preparing executive or Board-level presentations, supporting scientific advisory boards, and working in a lean biotechnology organization.

Responsibilities

Partner with the VP, Clinical Development to evaluate portfolio opportunities, emerging risks, and development options, and provide clinical and scientific perspectives that inform strategy and priorities.
Collaborate with global study leads to develop and refine clinical development plans and study strategies, including patient populations, dose and schedule, endpoints, biomarkers, geographic considerations, and evidence needs.
Apply early development expertise to first-in-human studies, dose escalation, dose optimization, and expansion cohorts, integrating emerging safety, efficacy, pharmacology, and translational data into recommendations.
Contribute to the design, conduct, interpretation, and communication of clinical studies, including protocols, amendments, investigator materials, and clinical study reports.
Partner with study leads and Clinical Operations to address clinical issues and support study milestones.
Partner with global study leads and Pharmacovigilance to review emerging safety data, assess potential signals and benefit-risk, and recommend follow-up and risk mitigation.
Serve as a backup medical monitor, covering investigator questions, eligibility assessments, medical review of adverse events, and protocol-related medical decisions.
Support safety review meetings and clinical interpretation of adverse events and laboratory trends, translating findings into monitoring recommendations, protocol updates, and communications to study teams.
Support preparation of clinical content for regulatory submissions, briefing documents, responses to health authority questions, and regulatory meetings, and participate in interactions as appropriate.
Help prepare Board of Directors materials and executive updates, synthesizing clinical progress, safety findings, development options, and risks into presentations and recommendations.
Build and maintain relationships with investigators, academic centers, and external oncology experts; travel domestically and internationally for site engagement, investigator meetings, scientific congresses, and advisory discussions as needed.
Gather investigator insights on study design, feasibility, enrollment barriers, and clinical practice, and apply them to clinical strategy and study execution.
Help plan and lead scientific advisory boards and expert discussions, develop focused questions, evaluate external input, and translate recommendations into practical development options.
Collaborate across Clinical Operations, Pharmacovigilance, Translational Medicine, Biostatistics, Data Management, and Regulatory Affairs to align on clinical questions, resolve issues, and support timely decisions.
Mentor colleagues and contribute to consistent clinical development practices that support patient safety, scientific rigor, data integrity, and quality.