Non-clinical Operations Manager / Sr. Manager at Tenaya Therapeutics
South San Francisco, CA, US

Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology company with a mission to discover, develop and deliver curative therapies that address the underlying causes of heart disease. Founded by leading cardiovascular scientists from Gladstone Institutes and University of Texas Southwestern Medical Center (UTSW), we are advancing a deep and diverse pipeline that includes both gene therapies and small molecules.

Tenaya is headquartered in South San Francisco, California, USA, with a team that comprises over 100 employees. Inspired by the majesty of Tenaya Peak in Yosemite National Park, our name represents the tenacity of our team in reaching our ultimate peak – the delivery of new therapies for heart disease to the patients who need them.

For more information, please visit www.TenayaTherapeutics.com and follow us on LinkedIn.

Diversity & Inclusion is a core Value for Tenaya Therapeutics and we encourage those from under-represented communities to apply.

Role

Tenaya Therapeutics is seeking a highly motivated nonclinical operations Manager/Sr. Manager to join our Research group. The successful candidate will support nonclinical contract lab operations including efficacy studies and both exploratory and IND-enabling safety/toxicology studies. Responsibilities include tracking study timelines to support toxicology and translational medicine related activities. The nonclinical operations manager will be responsible for the operational activities associated with performing non-GLP and GLP toxicology studies related to Tenaya’s pipeline development, including organizing and tracking of nonclinical studies and sample management, managing resources and timelines. Relevant scientific and technical experience with toxicology, DMPK and bioanalytics is preferred.

Responsibilities:

  • Effectively manage day-to-day operations of study-related activities with toxicologists and external contract research organizations (CRO) to ensure program needs and timelines are met.
  • Support contracts process for approval and full execution of NDA, MSA and SOW documents. Establish purchase orders for external study contracts, track budgets, anticipate scope changes, and communicate changes that may impact the project budget to appropriate key stakeholders. Track invoices from CROs and route for approval for milestone payments according to study progress.
  • Track nonclinical study milestones against project goals. Tracking progress of protocol reviews, protocol/report amendments, study reports in a timely fashion.
  • Assist toxicologists and QA to facilitate CRO vendor selection/audit and due diligence activities to ensure high-quality deliverables from CROs. Support the development and/or review of SOPs, policies, and guidelines. Travel to CROs to monitor study critical phases as needed.
  • Monitoring Non-GLP studies required for preclinical testing of drug candidates. Support activities related to GLP toxicology studies including monitoring study progression, data acquiring, sample tracking and coordinating shipping/receiving to and from CROs.
  • Supporting data acquiring from CROs and process data to generate tables, figures, and listings to support nonclinical study reports and regulatory submissions.
  • Participation in regulatory submissions when needed (eg, preparation and/or review applicable nonclinical sections of IBs, NDAs, BLAs, etc.).
  • Other duties and responsibilities as required by departmental and business needs.

Requirements

  • BS or MS in a life science or related fields.
  • 2+ years experience in the pharmaceutical, biotechnology with hands on nonclinical technical background or CRO industry
  • Familiarity and knowledge of a broad range of nonclinical studies relevant to drug development (Toxicology, DMPK, Bioanalytical, Biology, Pharmacology) is desirable.
  • Proficiency in Microsoft Word, PowerPoint, Excel and GraphPad Prism. Ability to learn and use additional software as needed for data organization, tracking and presentation.
  • Familiarity with accounting and budget tracking is highly desirable.
  • Strong time management and organizational skills, attention to accuracy and detail, and the ability and willingness to multi-task as needed.
  • Strong written, verbal, and interpersonal communications skills. Demonstrated ability to be a team player who thrives in a fast-paced environment and takes the initiative to identify, analyze and resolve issues.
  • Limited travel (~5%) may be required vender inspections and conferences.

Benefits

We offer a dynamic start-up environment and a collaborative, passionate team that is focused on a compelling vision and mission.

We offer competitive salary and stock options. Excellent medical and non-medical benefits. Paid vacation, sick time and holidays.

State-of-the-art, built-to-suit office and lab space, part of a larger cluster of biotech companies, with amenities that include a bowling alley and onsite gym.

Shuttle service to/from Caltrain, BART and the South San Francisco Ferry.

Tenaya is proud to be an equal opportunity workplace.