Sr. Director, Clinical Operations

Sutro Biopharma•South San Francisco, CA

About The Position

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.

Requirements

Open, effective, and proactive communication of the clinical development activities is critical for success in this role
Demonstrated experience managing and mentoring team members. Effective leadership skills and proven ability to foster team productivity and cohesiveness
Highly motivated and thrive working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient
Must have an excellent understanding of functional areas of drug development, including preclinical, regulatory, quality, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization)
Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations
Thorough understanding of the drug development process from pre-IND through registration and post-registration desirable.
Able to interact cross-functionally at all levels within Sutro and externally with consultants, contractors, and investigators
Must have strong work ethic and be able to work independently and productively under pressure with changing priorities
Strong organizational skills and the ability to prioritize and multi-task with exceptional verbal and written communication skills
Possess strategic thinking and proactive identification of issues, excellent judgment, and problem-solving skills
Ability to operate and cooperate at all levels within a project, from oversight to hands-on management of day-to-day activities
Flexible as it relates to responsibilities/assignments since Sutro is a small company and job scope/role will inevitably evolve as the company and department matures
Willingness to travel as necessary, consistent with project needs
Computer proficiency (Outlook, MS Word, Excel, and PowerPoint)
University/college degree in health care or other scientifically related discipline is required. An advanced degree (e.g., Masters, MBA, MD, PhD) is preferred
Five (5) or more years of experience in a leadership function in clinical operations with a proven track record of people and project management, strong background in drug development; working knowledge of details and issues involved in different functional areas
Experience in a scientific discipline, with clinical drug development experience, strategic planning specifically in the pharmaceutical or biotech industries is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility

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.