Sutro Biopharma, Inc. is currently searching for a Senior Director, Medical Safety and Pharmacovigilance to review adverse event reports and provide support to the Clinical Development, Regulatory, Biometrics, Clinical Operations and Clinical Science groups. The role will provide medical consultation to the Product Development Teams and Clinical Development and Regulatory Team (CDRT) and make contributions to process improvements. This position reports into the Vice President, Clinical Development.#Li-DNI
- Performs medical review of individual case safety reports. Reviews adverse event reports, adhering to standard operating procedures for medical assessment of individual case safety reports providing medical safety assessment and pharmacovigilance comment.
- Provide safety input to clinical development plans, study protocols, amendments, IB, statistical analysis plan (SAP), ICF, CSR, responses to HA or institutional review board (IRB)/ ethics committee (EC) queries.
- Oversee, prepare, and/or review aggregate safety review documents (e.g., DSUR, PBRER) and safety sections of relevant clinical trial documents (e.g., protocols, clinical study report [CSR], investigator brochure [IB], informed consent form [ICF]) and regulatory filings.
- Lead the evaluation & management & documentation of signals emerging from any data source. Develop strategy for signal evaluation (e.g., case-series, literature review, HA/ claims database).
- Provides medical consultation including literature review and management on an ad hoc basis
- Makes contributions to process improvement, particularly with adverse event processing and operational aspects of medical review
- Supports medical review group with other ad hoc projects
- Lead safety activities and benefit-risk strategies for assigned compound(s)/ program. Establish and chair the product Safety Management Team(s) as required.
- Assist the team and senior management in all forms of issue management
- Requires an MD/DO degree or equivalent
- Completion of an accredited medical or surgical residency program is required. Board certification is preferred.
- Demonstrates an excellent scientific/clinical and analytical knowledge base, with ability to assess individual case safety reports and understand the safety/medical implications
- Demonstrates independence in effectively managing projects
- Excellent written and verbal communication skills
Sutro Patient Safety Mission
To protect patients through timely collection and reporting of safety information and proactive and comprehensive risk/benefit evaluation, ensuring patient safety and Sutro’s compliance with global regulations for our therapies throughout their life cycle. We advance therapeutics through a collaborative and patient-centric approach to pharmacovigilance, leveraging innovative technology.
Sound exciting? Apply today and join our team!
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.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.
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.
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.