Senior Manager/Associate Director, Non-Clinical Study Operations

South San Francisco, California, United States

 

Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.

We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.

We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.

For more information see: www.septerna.com.

About The Role

We are seeking a highly motivated Sr. Manager, Nonclinical Study Operations to join our Nonclinical Team.  This individual will be responsible for planning, managing, executing, and coordinating the finalization of nonclinical studies, including GLP and nonGLP pharmacology, toxicology, and DMPK studies.  The Nonclinical Study Operations manager will work closely with internal and external stakeholders to ensure high-quality study execution, compliance with regulatory guidelines, and alignment with program timelines and study team objectives.


Responsibilities 

  • Effectively manage day-to-day operations of study-related activities between nonclinical development scientists and contract research organizations (CRO) to ensure program needs and timelines are met
  • Support contracts process for approval and full execution of nondisclosure agreements (NDA), master service agreements (MSA), and statements of work (SOW). Establish purchase orders to support study contracts, track budgets, address scope changes and communicate issues that may impact the project budget to key stakeholders.  Track and approve invoices from CRO and route for approval for milestone payments according to study progress
  • Organizing and tracking nonclinical study progress, sample management, and timelines.
  • May include on site study monitoring, data processing to generate tables, figures, and listings to support nonclinical study reports and regulatory submissions.
  • Participate in study design or project team discussions as needed to support team deliverables and goals.

Qualifications

  • BS or MS in a life science field
  • 5-8+ years experience in nonclinical study management within biotech, pharmaceutical, or Contract Research Organizations
  • Experience managing CROs and external vendors
  • Relevant scientific and technical experience in nonclinical study design and conduct is preferred.
  • Demonstrated ability to work cross-functionally and actively identify, analyze, and address issues as they arise
  • Strong organizational skills, attention to detain, and the ability to manage multiple workstreams simultaneously are needed
  • Excellent written, verbal, and interpersonal communications skills.
  • Familiarity with contracting, accounting, and budget tracking is highly desirable
  • Proficient in the use of Microsoft Word, PowerPoint, Excel, and GraphPad Prism
The anticipated salary range for candidates who will work in South San Francisco, CA is $160,000 - $180,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.

 

 
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.  We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.  Septerna participates in the E-Verify program.  California Consumer Privacy Act Privacy Notice For Job Applicants.  If you are a California resident, click here for our CCPA Notice.

 

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