Sr. Director, Clinical Operations

SENIOR DIRECTOR, CLINICAL OPERATIONS

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 collab