Director, Clinical Development – MD (South San Francisco, CA)

Location
South San Francisco, CA
Posted
Jan 18, 2022
Required Education
Doctorate/PHD/MD
Position Type
Consultant

 

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 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 Director, Clinical Development will report to the VP of Clinical Development 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 Phase 2 registration-directed clinical study. The role is as a lead medical monitor for a registration study and will work closely with the VP of Clinical Development. This physician scientist will provide clinical and development expertise and will work closely with cross-functional teams to execute on the conduct, analysis and filing of data from a registration study. In addition, the Director will work as part of the clinical team in executing and contributing to the development strategy of the compound. 

Responsibilities

  • Serve as the lead Medical Monitor for a phase 2 or 3 clinical registration trial to address patient eligibility and treatment questions in cooperation with the contract research organization (CRO) medical monitors or directly with study investigators and coordinators
  • Lead medical monitor for a Phase 2 or 3 registration study with oversight of CRO medical monitors
  • Provide clinical input into study design and implementation as a lead clinical representative on the study
  • Participate in interpretation of data analyses of clinical trial results and developing clinical trial reports
  • Work with clinical operations to drive and support study enrollment
  • Work with data management, clinical scientists, clinical operations and biostatistics on data cleaning in preparation for formal study analyses or for regulatory document updates
  • Preparation, design, and/or review of clinical documents, e.g. protocols, investigator’s brochures, case report form design
  • Participate in site/investigator identification and evaluation for clinical trials; conduct site initiation visits and engagement calls
  • Contribute as an authoring of clinical sections of relevant regulatory filings (IND, study reports, etc.)
  • Participate with Safety to review safety data for routine medical data review, trend review, and safety signals from ongoing trials
  • Review serious adverse event (SAE) reports from ongoing clinical studies and work in close collaboration with the CRO to review causality and develop MedWatch/CIOMS reports (including narratives and analyses of similar events) for reportable SAEs
  • Represent the company at scientific meetings and presentations
  • Participate in study investigator meetings
  • Support study outreach and medical affairs activities
  • Contribute to scientific affairs with authoring and/or reviewing abstracts, presentations and manuscripts for medical accuracy and content
  • Attend and provide medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards)
  • Develop and manage relationships with key opinion leaders for clinical programs
  • Provide clinical oncology input to internal early-stage project teams

Qualifications

  • M.D. or M.D./Ph.D., with board certification or eligibility in oncology or hematology/oncology preferred
  • 8 plus years of experience with a minimum of 3 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
  • 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. #2235 . Please visit our website at www.sutrobio.com for more information.

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.

Please be advised, inquiries or resumes from recruiters will not be accepted.

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.