Sutro Biopharma, located in South San Francisco, is developing a new generation of multi-functional antibody drug conjugate combination therapeutics and bifunctional antibody-based therapeutics for targeted cancer therapies. These therapeutics will significantly extend the clinical impact of current oncology treatment approaches and are beyond what can be envisioned with traditional cell-based expression technologies. Sutro's biochemical synthesis technology, which underpins these therapeutics, allows the rapid and systematic exploration of many protein drug variants to research, discover and develop drug candidates. Our make-test cycle for hundreds of protein variants, including those incorporating non-natural amino acids, takes approximately two weeks. Once identified, production of these protein drug candidates can be rapidly and predictably manufactured at commercial scales. In addition to developing its own drug pipeline, Sutro Biopharma is collaborating with select pharmaceutical and biotech companies in the research, discovery, development, and manufacture of novel protein therapeutics.
Position Summary:
The Senior Director, Clinical Operations acts as the single point of accountability for Clinical Operations and reports into the Head of Clinical Development to ensure the integrity and success of Sutro’s clinical trials. This position ensures there is alignment of Clinical Operation goals with organizational objectives.
The Senior Director, Clinical Operations is a key cross-functional team member contributing to the design and execution of Sutro’s clinical trials. The position is responsible and accountable for managing the overall clinical operational activities of Sutro’s Clinical Programs. Providing strategic and operational leadership will ensure milestones are delivered on time, within budget, with high quality, and in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs. The position is responsible for ensuring that studies/programs are resourced appropriately and timely.
This position is responsible for coordination of all activities performed by Clinical Operations team. This position is accountable for the management and development of staff within his/her scope of responsibility while fostering a diverse work force.
Responsibilities:
• Lead Clinical Operations Teams to expedite execution of clinical trials, Including participating in the design, implementation and review of clinical protocols and study reports for scientific and operational accuracy.
• Acquire and sustain advanced knowledge of the therapeutic area and product and clinical trial setting. Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms to apply knowledge to support a robust clinical development strategy.
• People management responsibility for all staff within the Clinical Operations group. Support the development of Human Resources programs which include performance, talent management, and training requirements, sharing of information and best practices. Willing to take on a mentoring role for members of the Clinical Operations team.
• The position takes overall responsibility to ensure role training for the team is completed and current. Works with Quality Assurance team to develop, maintain and document appropriate training for compliance with GxP standards.
• Establish strong interaction with the Cross-functional partners within the company. Serve as the escalation point of contact for internal/external team members.
• Responsible for timely study execution delivering high-quality clinical study data; collaborate to present clinical study results to the cross functional team and to the company Senior Management Team and external stakeholders.
• Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators, CRO, and field team on developing robust study protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Close engagement with study sites is essential to ensure timely and high-quality execution of clinical studies.
• Lead or assist in writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB/EC and HA submissions/approvals, ct.gov postings, site activations, monitoring plan and tools, CRF’s, DMP, edit checks, safety plan, Safety Evaluation Team and DMC charter, close-out plans, inspection readiness plans, and CSRs.
• Participate in or accountable for the selection process of CROs and vendors.
• Responsible for assisting with strategic planning for site/country selection, contract negotiations and oversight of vendors, patient recruitment, and ensuring proper study conduct.
• Assist with the development of materials for and coordination of Investigator Meetings, Advisory Boards, Study Monitoring boards. Assist in writing publications and scientific presentations.
• Ensure that all studies are conducted with the highest level of ethical and safety standards and follow GCP and all regulatory policies. This team member will provide operational expertise to internal teams (CMC, regulatory affairs, non-clinical, medical writing, biometrics, and pharmacovigilance) and external teams (CROs, consultants) to ensure that Clinical Development scientific and medical strategies are met.
• Collaborate with Clinical Development and Finance to develop and effectively manage annual budget for clinical activities and budget forecasting.
• Review contracts and work closely with the Legal department to ensure execution of contracts per company requirements and to planned timelines.
Qualifications:
Education/Experience:
Working Conditions
Sound exciting? Apply today and join our team!
Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for COVID-19 prior to the first date of employment.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $284,000 - $316,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.
About Sutro Biopharma
Sutro Biopharma, Inc. is advancing a next-generation antibody-drug conjugate (ADC) platform designed to deliver single- and dual-payload ADCs that enable meaningful breakthroughs for patients with cancer. By fully optimizing the antibody, linker, and payload, Sutro’s cell-free platform produces ADCs that are engineered to improve drug exposure, reduce side effects, and expand the range of treatable tumor types. With unique capabilities in dual-payload ADCs, Sutro aims to overcome treatment resistance and redefine what’s possible in cancer therapy. The Company’s pipeline of single- and dual-payload ADCs targets large oncology markets with limited treatment options and significant need for improved therapies