Director, Clinical Research at Atreca
South San Francisco, CA, US

Atreca is an integrated biotechnology company located in South San Francisco, California (moving in 2021 to a new campus in San Carlos, CA). We apply our proprietary drug discovery platform to profile clinically relevant, active B cell responses in patients receiving successful treatment and, in turn, develop a portfolio of antibody therapeutics against novel tumor targets with the potential to treat large patient populations. Atreca seeks talented, driven individuals who are dedicated to making a positive impact on human health and are motivated to become key members of a growing biotechnology company.

Position Summary

Atreca is looking to hire a Director, Clinical Research to provide clinical and scientific support in all aspects of clinical development programs from the discovery of anticancer antibodies to the creation and execution of a clinical development strategy.

Duties and Responsibilities

  • Provide leadership in the design of clinical development plans
  • Collaborate with investigators, opinion leaders, and internal stakeholders in study design, execution, and reporting
  • Support the development of clinical sections for regulatory correspondence and submissions including but not limited to Information Requests, Briefing Books, presentation materials, and IND/NDAs
  • Co-author key study documents, including protocols and amendments, investigator brochures, and clinical study reports
  • Review study related documents such as medical monitoring plans, statistical analysis plans, data management plans, CRF completion guidelines, data validation manuals, and safety management plans
  • Collaborate with Clinical Operations, Clinical Informatics, Safety, and Translational Medicine to execute clinical studies
  • Monitor, analyze, and interpret clinical study data
  • Author and/or review abstracts, posters, content for scientific meetings, conferences, other events and presentations, and any other distributed materials
  • Provide support for advisory boards, consultant meetings, and investigator meetings including preparation of presentations
  • Work with business development and other internal stakeholders to generate target product profiles
  • Provide clinical expertise for the sourcing and evaluation of patient-derived samples for Atreca’s discovery pipeline
  • Conduct clinical due diligence for business-development opportunities
  • Conduct daily activities in compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs

Required Skills and Qualifications

  • MD, PhD, Pharm D, or MSN
  • 3 or more years of clinical research experience in the biopharmaceutical industry, with specific experience and expertise in oncology
  • Experience as a medical monitor of an investigational clinical trial preferred
  • Experience with clinical trial data listings
  • Experience working on a cross functional clinical team
  • Experience authoring global clinical development plans and clinical study protocols
  • Experience with health authority and IRB/EC submissions, as well as IND and NDA/BLA filings preferred|
  • Experience across drug development phases preferred
  • Ability to work productively in a fast-paced collaborative environment, sometimes with limited supervision
  • In-depth knowledge of clinical oncology
  • Sound clinical judgement
  • Knowledge of Good Clinical Practices, FDA and ICH regulations
  • Excellent cross-functional team leadership and participation skills
  • Excellent interpersonal skills to be able to build strong internal and external relationships
  • Excellent written and verbal communication skills as well as the ability to present information to a wide range of groups/entities
  • Ability to develop and maintain relationships with stakeholders from various internal and external functions
  • Strong working knowledge of MS Office

Exact title commensurate with experience. Atreca is an equal opportunity employer.