Overview
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 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. Responsibilities
Provide quality oversight and GCP guidance to clinical study teams and CROs/vendors to ensure compliance with ICH GCP, applicable regulatory requirements, and Septerna standards. Ensure clinical trials are conducted in accordance with GCP principles, producing high-quality and reliable data. Evaluate clinical trial documentation, study processes, and operational plans to confirm alignment with Septerna expectations and applicable regulations. Interpret and apply clinical and regulatory compliance requirements to support Septerna’s objectives and ensure effective implementation across programs. Collaborate with clinical study teams to provide vendor quality oversight, identify and assess risks, and recommend appropriate remediation actions. Develop and execute GCP audit plans for assigned clinical studies as part of ongoing quality oversight. Partner with clinical functions to provide quality guidance and drive the implementation of fit-for-purpose procedures that ensure data and documentation are generated and managed in compliance with GCP. Work with cross-functional teams to assess and manage risks associated with vendors, supporting study compliance, data integrity, and participant safety. Assist in periodic reporting of key quality metrics to leadership to support continuous improvement in GCP compliance across Septerna. Promote a culture of quality through effective communication, training, and proactive engagement with internal and external stakeholders. Qualifications
Bachelor’s degree in life sciences or a related field; an advanced degree is preferred. Minimum of 15 years of professional experience in Quality Assurance within the biopharmaceutical industry, with progressive responsibilities in Clinical QA. Minimum of 6 years of direct GCP audit experience, including investigator sites, CROs, and other clinical vendors. Proven ability to evaluate the effectiveness of CAPAs and follow up on audit findings to ensure timely and complete resolution. Strong knowledge of ICH GCP and applicable global regulatory requirements governing clinical research. Demonstrated experience providing GCP oversight of clinical studies and vendor programs. Skilled in authoring and revising SOPs, implementing process improvements, and ensuring quality systems remain phase-appropriate and fit-for-purpose. Demonstrated ability to assess compliance risks, interpret regulations, and implement practical, risk-based quality solutions. Excellent collaboration and communication skills with the ability to work effectively across functional areas and external partners. Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment. The anticipated salary range for candidates who will work in South San Francisco, CA is $260,000 - $285,000. 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. 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. Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Septerna’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
#J-18808-Ljbffr
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 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. Responsibilities
Provide quality oversight and GCP guidance to clinical study teams and CROs/vendors to ensure compliance with ICH GCP, applicable regulatory requirements, and Septerna standards. Ensure clinical trials are conducted in accordance with GCP principles, producing high-quality and reliable data. Evaluate clinical trial documentation, study processes, and operational plans to confirm alignment with Septerna expectations and applicable regulations. Interpret and apply clinical and regulatory compliance requirements to support Septerna’s objectives and ensure effective implementation across programs. Collaborate with clinical study teams to provide vendor quality oversight, identify and assess risks, and recommend appropriate remediation actions. Develop and execute GCP audit plans for assigned clinical studies as part of ongoing quality oversight. Partner with clinical functions to provide quality guidance and drive the implementation of fit-for-purpose procedures that ensure data and documentation are generated and managed in compliance with GCP. Work with cross-functional teams to assess and manage risks associated with vendors, supporting study compliance, data integrity, and participant safety. Assist in periodic reporting of key quality metrics to leadership to support continuous improvement in GCP compliance across Septerna. Promote a culture of quality through effective communication, training, and proactive engagement with internal and external stakeholders. Qualifications
Bachelor’s degree in life sciences or a related field; an advanced degree is preferred. Minimum of 15 years of professional experience in Quality Assurance within the biopharmaceutical industry, with progressive responsibilities in Clinical QA. Minimum of 6 years of direct GCP audit experience, including investigator sites, CROs, and other clinical vendors. Proven ability to evaluate the effectiveness of CAPAs and follow up on audit findings to ensure timely and complete resolution. Strong knowledge of ICH GCP and applicable global regulatory requirements governing clinical research. Demonstrated experience providing GCP oversight of clinical studies and vendor programs. Skilled in authoring and revising SOPs, implementing process improvements, and ensuring quality systems remain phase-appropriate and fit-for-purpose. Demonstrated ability to assess compliance risks, interpret regulations, and implement practical, risk-based quality solutions. Excellent collaboration and communication skills with the ability to work effectively across functional areas and external partners. Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment. The anticipated salary range for candidates who will work in South San Francisco, CA is $260,000 - $285,000. 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. 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. Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Septerna’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
#J-18808-Ljbffr