The Executive Director, Clinical Sciences is a key cross-functional team member contributing to the design and execution of Sutro’s clinical trials. The Clinical Scientist is responsible for analyzing and interpreting study data (trial and individual patient level) and translating clinical data across and within the programs and studies. They also 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 expertise to internal teams (CMC, clinical operations, 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.
The Executive Director, Clinical Sciences will work closely with the Chief Medical Officer and VP of Clinical Development, and/or Program Lead to ensure the integrity and success of Sutro’s clinical trials. Open, effective, and proactive communication of the clinical development activities is critical for success in this role. Must have an excellent understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization) biomarkers and publications. Thorough understanding of the drug development process from pre-IND through registration and post-registration desirable. Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have strong work ethics and be able to work independently and productively. Must be willing to travel as business needs requires.
- Contribute to the design, implementation and review of clinical protocols and study reports for scientific and operational accuracy.
- Contribute to the design, start-up, execution, analysis, and communication of the clinical studies for a product candidate.
- In collaboration with Clinical Operation and Statistics, responsible for timely delivery of high-quality clinical study data analysis; present clinical study results to the cross functional team and to the company Senior Management Team and external stakeholders
- Work very closely with study investigators to ensure timely and high-quality execution of clinical studies.
- Work with KOLs to review clinical data and develop clinical development strategy.
- Collaborate with Clinical Operations to expedite execution of clinical trials.
- Internal data review for integrity and to identify trends.
- 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.
- Assist and support regulatory filing activities.
- 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. Performs site monitoring with field team, as needed.
- Responsible for writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, Pharmacy Manuals, informed consent, IRB submissions/approvals, site activations, monitoring plan and tools, CRF’s, DMP, edit checks, safety plan, Safety Evaluation Team and DMC charter, close-out plans, and CSRs.
- Integrate and organize ad boards, Steering Committee as requested.
- Assist with the development of study presentations, handouts, and coordination of Investigator Meetings
- Analyze data and assist in writing for publications and scientific presentations.
- In cooperation with Clinical Operations and Finance, develop and effectively manage annual budget for clinical activities.
- Ph.D. in biology/bioengineering/biochemistry or other scientifically based field with prior experience managing oncology trials; A Master’s degree may be considered with supporting industry experience.
- The candidate should have a minimum of 10 years of clinical research experience in domestic and international clinical trials, oncology trial experience is required.
- Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations
- Able to work independently and make appropriate strategic decisions to operationalize and move the clinical trials forward.
- Excellent written and oral communication and presentation skills
- The ability to manage multiple priorities, while maintaining attention to detail is critical.
- Experience operating effectively within a matrixed environment, specifically in a healthcare biotech/pharmaceutical start-up setting.
- Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities.
- Possess strong and influential leadership skills with proven ability to lead internal and external team members at all levels.
- Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook, and IXRS/EDC platforms)
Sound exciting? Apply today and join our team!
Please visit our website at www.sutrobio.com for more information and to learn more about how we collaborate and work together at Sutro.
Sutro Biopharma, Inc. requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Sutro will consider requests for reasonable accommodations.
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.
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 300,000 - 350,000 (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 a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF®, provides the opportunity for broader patient benefit and an improved patient experience. Sutro has multiple clinical-stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in clinical studies. A robust pipeline, coupled with high-value collaborations and industry partnerships, validates our continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com.