Executive Director, Clinical Development – MD (South San Francisco, CA)
Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Clinical Development team as we change the future of oncology. While collaborating with cross-functional departments, you will play a key role in maximizing our better by design technology and progressing our novel therapeutics. We are dedicated to making a difference in the lives of patients, both as individuals and as part of a team.
The Executive Director, Clinical Development will report to the Chief Medical Officer and will be responsible for the design, execution, medical monitoring, data analysis, working with safety for study safety oversight, and help with preparation of regulatory documents including a BLA filing of a registration-directed clinical study. This role will be responsible for leading other clinical development strategies stemming from our discovery research portfolio. This role is a lead medical monitor for a registration study and will collaborate closely with cross functional teams to execute on the conduct, analysis and filing of data for a registration study. In addition, the Executive Director will work as part of the clinical team in executing and contributing to the development strategy of the clinical and pre-clinical pipeline.
- Facilitate generation of, author, update, and / or review key documents, including, but not limited to: Protocol concepts, synopses, protocols, and amendments, Informed consent documents, investigator brochures, clinical study reports, abstracts, posters and manuscripts, clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), annual reports, and developmental safety update reports, clinical sections of health authority briefing documents, Orphan Drug applications, and annual reports. Risks / benefits analysis for applicable documents.
- Clinical Development Plans: Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies
- Provide scientific expertise for selection of investigator and vendors.
- Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs / IECs, Health Authorities, and CRO’s.
- Review, query, and analyze clinical trial data.
- Interpret, and present clinical trial data both internally and externally.
- Represent a clinical study or development program on one or more teams or sub teams.
- Create clinical study or program-related slide decks for internal and external use.
- Build and maintain opinion leader / investigator networks; organize and present at key opinion leader advisory boards and investigator meetings.
- Contribute to or perform therapeutic area / indication research and competitor analysis,
- Build strong relationships with internal experts.
- Identify continuous process improvement opportunities.
- Monitors own work to ensure quality: Analytical – synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data.
- Problem Solving – identifies and resolves problems in a timely manner; gathers and analyzes information skillfully.
- Project Management – communicates changes and progress; completes projects on time and budget.
- Identify incremental organizational resource needs staff, budget, and systems.
- Develop, track, execute and report on goals and objectives.
- Support budget planning and management.
- Be accountable for compliant business practices.
- Communication – listens and gets clarification; responds well to questions; speaks clearly and persuasively in positive or negative situations.
- Writes clearly and informatively. Able to read and interpret written information.
- Teamwork – balances team and individual responsibilities; gives and welcomes feedback; contributes to building a positive team spirit.
- Puts success of team above own interests; supports everyone’s efforts to succeed.
- Contributes to building a positive team spirit, shares expertise with others.
- Adaptability – able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation.
- Able to deal with frequent change, delays, or unexpected events.
- Technical Skills – assesses own strengths and development areas; pursues training and opportunities for growth; strives to continuously build knowledge and skills.
- M.D. or M.D./Ph.D., with board certification or eligibility in oncology or hematology/oncology preferred.
- 12+ years of experience with a minimum of 5 years of oncology clinical trial experience in pharmaceutical or biotech industries preferred.
- Experience with clinical trial design, conduct, and medical monitoring.
- Participation as a medical monitor on a registration study.
- Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials (i.e., from start up to study report), ideally having taken at least one study through from start to finish in a clinical scientist role.
- Clinical oncology experience: candidates with exceptional experience in other therapeutic areas would be considered if they demonstrated clear potential to apply their existing skills to oncology.
- Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing.
- High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills.
- Experience with the development and support of related SOPs and policies is expected.
- Flexibility to work with colleagues in a global setting.
- Knowledgeable and current in GCP guidelines in US and Europe
- Hands-on experience with clinical trial strategy, methods, and designs
- Ability to work proactively and effectively, with exceptional creative problem-solving skills.
- Excellent strategic planning, organizational and communication skills
- Up to 25% travel (US and international)
Sound exciting? Apply today and join our team!
Please submit resume for Req. #23-700-005A to firstname.lastname@example.org. Please visit our website at www.sutrobio.comfor 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.
Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.
Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro’s platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal.
The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.