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Senior Director, Medical Safety and Pharmacovigilance (MD/DO) (South San Francisco, CA)

Employer
Sutro Biopharma, Inc
Location
South San Francisco, CA
Start date
Jul 19, 2022

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Job Details

 

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

Responsibilities

  • 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

Qualifications

  • 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.

Company Overview

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.

 

Company

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’s proprietary and integrated cell-free protein synthesis platform XpressCF® and site-specific conjugation platform XpressCF+™ led to the discovery of STRO-001 and STRO-002, Sutro’s first two internally-developed ADCs. STRO-001 is a CD74-targeting ADC currently under investigation in a Phase 1 clinical trial for patients with advanced B-cell malignancies, and was granted Orphan Drug Designation by the FDA for multiple myeloma. STRO-002, a folate receptor alpha (FolRα)-targeting ADC, is currently being investigated in a Phase 1 clinical trial for patients with ovarian and endometrial cancers and was granted Fast Track designation by the FDA for ovarian cancer. A third product candidate, CC-99712, a BCMA-targeting ADC, which is part of Sutro’s collaboration with Bristol Myers Squibb, formerly Celgene Corporation, is enrolling patients for its Phase 1 clinical trial of patients with multiple myeloma and has received Orphan Drug Designation from the FDA. A fourth product candidate, M1231, a MUC1-EGFR, first-in-class bispecific ADC, which is part of Sutro’s collaboration with Merck KGaA, Darmstadt, Germany, known as EMD Serono in the U.S. and Canada (EMD Serono), is enrolling patients for its Phase 1 clinical trial of patients with metastatic solid tumors, non-small cell lung cancer (NSCLC) and esophageal squamous cell carcinoma. These four product candidates above being evaluated in clinical trials resulted from Sutro’s XpressCF® and XpressCF+™ technology platforms. Bristol Myers Squibb and EMD Serono have worldwide development and commercialization rights for CC-99712 and M1231, respectively, for which Sutro is entitled to milestone or contingent payments and tiered royalties.

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 ADCs, bispecific antibodies, cytokine-based immuno-oncology therapies, and vaccines 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.

Follow Sutro on Twitter, @Sutrobio, and at www.sutrobio.com to learn more about our passion for changing the future of oncology.

Stock Symbol: STRO

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Find Us
Website
Phone
650.881.6500
Location
111 Oyster Point Blvd
South San Francisco
California
94080
United States
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