California Jobs
Senior Manager/Associate Director, Non-Clinical Study Operations
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Job Description
- Req#: 32505982402
- Manage daily operations of study-related activities between nonclinical development scientists and contract research organizations (CROs) to meet program needs and timelines.
- Support contract processes for approval and execution of nondisclosure agreements (NDAs), master service agreements (MSAs), and statements of work (SOWs). Establish purchase orders, track budgets, address scope changes, and communicate issues impacting budgets to stakeholders. Approve invoices from CROs and route for milestone payments based on study progress.
- Organize and track nonclinical study progress, sample management, and timelines.
- May include on-site study monitoring and data processing to generate tables, figures, and listings for study reports and regulatory submissions.
- Participate in study design or project team discussions to support team deliverables and goals.
- BSc or MSc in a life sciences field.
- 5-8+ years experience in nonclinical study management within biotech, pharma, or CROs.
- Experience managing CROs and external vendors.
- Relevant scientific and technical knowledge in nonclinical study design and conduct.
- Proven ability to work cross-functionally, identify, analyze, and resolve issues.
- Strong organizational skills, attention to detail, and ability to manage multiple workstreams.
- Excellent communication skills (written, verbal, interpersonal).
- Familiarity with contracting, budgeting, and tracking is highly desirable.
- Proficiency in Microsoft Word, PowerPoint, Excel, and GraphPad Prism.
Job Description
Septerna is a biotechnology company based in South San Francisco, CA, on a mission to develop life-changing medicines for patients. Our vision is to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company's Complex Platform recapitulates GPCRs with their structure, function, and dynamics outside of the cellular context, enabling access to modern structural and screening technologies for industrial-scale drug discovery across the entire GPCR class. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential to target many undruggable and unexploited GPCRs.
We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address unmet patient needs. At Septerna, we foster collaboration and encourage employees to bring their authentic selves to work. Join our talented team of drug hunters, scientists, and business professionals to contribute your passion, creativity, and energy towards our mission. We are committed to ground-breaking innovations and cultivating an environment where our employees succeed through mutual learning and teamwork.
This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will play a direct role in advancing therapies through preclinical research, positioning them for clinical success. We seek a candidate who will bring their passion, talents, and expertise to our dynamic team, dedicated to discovering new disease-modifying therapeutics for patients in a fast-paced environment.
For more information, visit: www.septerna.com.
About The Role
We are seeking a highly motivated Senior Manager, Nonclinical Study Operations to join our Nonclinical Team. This individual will plan, manage, execute, and coordinate nonclinical studies, including GLP and non-GLP pharmacology, toxicology, and DMPK studies. The manager will work closely with internal teams and external stakeholders to ensure high-quality study execution, regulatory compliance, and alignment with program timelines and objectives.
Responsibilities
Qualifications
The anticipated salary range for candidates in South San Francisco, CA, is $160,000 - $180,000, with variations based on skills, experience, location, and education. The compensation package includes benefits, stock options, and an annual bonus.
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