Vice President, Clinical Development

Company: Stratus Therapeutics
Location: San Francisco
Posted on: June 2, 2025

Job Description:

POSITION SUMMARYPosition Title: Vice President, Clinical DevelopmentReports to: Chief Medical Officer (CMO) or Chief Executive Officer (CEO)Status: Regular, Full-Time, ExemptLocation: San Francisco Bay Area (Hybrid - In office on T, W, Th)Company Summary: Stratus Therapeutics is pioneering a new era in regenerative medicine with Stratus Prime - an off-the-shelf platform delivering Prime HSCs and Prime HPCs to restore the blood and immune systems where finding fully matched donors continues to be a challenge. Backed by leading life sciences investors, we are committed to developing universal, on-demand stem cell solutions to give physicians and their patients the power to replace the entirety of blood and immune function. This commitment, along with an exciting team culture, drives our efforts to develop an off the shelf stem cell therapeutic platform.Position Summary: The Vice President of Clinical Development will lead the strategic and operational development of clinical trials for our dynamic start-up biotechnology organization. You will build out this function and oversee the early clinical development of our novel hematopoietic stem cell therapies from first-in-human through proof-of-concept studies.Specific responsibilities include, but are not limited to:

• Define and execute the clinical development strategy for all programs in alignment with corporate goals.
  • Serve as the medical monitor for Phase 1 & 2 trials.
    • Lead the design and execution of early-phase (Phase 1 & 2) clinical trials.
      • Collaborate with cross-functional teams at Stratus to ensure the seamless translation from pre-clinical to clinical stages.
        • Provide medical and scientific oversight in guiding clinical trial protocols, study design, endpoints, and regulatory strategy.
          • Serve as the primary clinical representative in interactions with global regulatory authorities (e.g., FDA, EMA), contributing to IND/CTA filings and regulatory submissions.
            • Accountable for clinical program/study timelines, budgets and management of actual spend to approved budget.
              • Lead and mentor a high-performing clinical team, fostering a culture of inclusion, innovation, and scientific rigor.
                • Engage with external partners, including academic institutions, contract research organizations (CROs), and industry groups, to optimize clinical trial execution.
                  • Establish and update clinical operations SOPs, systems, work instructions, guidelines, standards, and best practices.
                    • Facilitate and oversee timely data analysis to ensure on-time availability of clinical study results and data integrity.Occasional travel to Boston office and other locations required.Qualifications include:
                      • MD is required, along with expertise in hematology and immunology.
                        • 10+ years of experience in clinical development, with a strong track record leading early-phase (Phase 1 & 2) clinical trials.
                          • Minimum of 5 years of industry experience in a small, fast-paced biotech organization.
                            • Experience presenting to the Board of Directors / Scientific Advisory Board preferred.
                              • Cell therapy experience is preferred.
                                • Strong people management skills and prior experience managing a clinical team is required.
                                  • Experience leading IND submissions and interactions with global health authorities is preferred.
                                    • Excellent organizational skills and attention to detail; willing to be hands-on and operate deep in the details within a fast-paced environment.
                                      • Clear and effective communication and interpersonal skills are required.
                                        • Must be able to laugh and contribute to a positive work culture.California Pay Transparency SB1162: The expected base salary range for this role is $320,000 - $380,000. Compensation will be based on a variety of factors, including experience, qualifications, and internal equity. Garuda offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
                                          AAP/EEO Statement
                                          Garuda Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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Keywords: Stratus Therapeutics, Sacramento , Vice President, Clinical Development, Executive , San Francisco, California