Associate Director, Clinical Regulatory Affairs
Description
Sutro Biopharma, Inc. is seeking a driven and talented individual to join our Regulatory team as we change the future of oncology. You will provide regulatory support in development and execution of regulatory strategies intended to support global clinical trial applications, marketing authorizations, and life cycle management of an expanding oncology portfolio in compliance with applicable regulatory requirements. Lead interactions with global health authorities and serve as a regulatory representative on cross-functional development teams. Experience in oncology drug development is required. While collaborating with cross-functional departments, you will play a key role in maximizing our 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.
Responsibilities:
- Leads and collaborates with Clinical and Preclinical functions the preparation, review, and finalization of submissions to global health authorities, including (but not limited to) protocols, investigator brochure’s, clinical study reports, clinical/nonclinical summaries and response to questions to support the initiation, maintenance, and closure of clinical studies and BLA/marketing applications and approvals.
- Oversees meeting strategy, preparations for and participates in meetings with regulatory agencies, including FDA and EMA.
- Provides strategic and operational leadership to direct preparation and completion of documents. Collaborates cross-functionally with subject matter experts to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
- Ensures regulatory documents are developed with high quality, delivered in a timely manner, are consistent with corporate strategy and compliant with current global regulatory requirements.
- Provides regulatory advice to the cross-functional development teams to ensure that the development plan is aligned with current global regulations.
- Leads collaboration with CROs for global regulatory submission planning and execution.
- Works with Project Management and Regulatory Operations to establish appropriate timelines and identify contingencies for delivery of assigned submissions in a timely manner.
- Monitors, analyzes, and disseminates intelligence on regulatory matters that may affect ongoing development programs.
Qualifications:
- Experience leading regulatory agency interactions (FDA meetings, EMA Scientific Advice, Advisory Committees, Oral Explanations, etc.) required
- Expertise in IND and Clinical Trial Application submissions and approvals in US, EU (under CTR preferred), Latin America, and Asia-Pacific
- Experience supporting BLA/marketing application submissions preferred
- Experience supporting development of pediatric study plans preferred
- Knowledge of US and international regulations as they apply to drug and biologic development, particularly in Oncology and rare diseases
- Demonstrated experience managing development of INDs and global clinical trial applications
- Strong technical and analytical skills with ability to make data-driven decisions
- Strong written and oral communication skills
- Strong leadership, negotiation, and collaboration skills
- Bachelor’s degree Life/Health Sciences; Master’s degree and/or Ph.D. a plus
- Minimum of 6+ years of experience in pharmaceutical / biotech with minimum of 4 years in Regulatory Affairs
Sound exciting? Apply today and join our team!
Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for COVID-19 prior to the first date of employment.
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.
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 (FRα)-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.