Septerna
Staff Scientist, Translational Sciences
Septerna, South San Francisco, California, us, 94083
THE ROLE
We are seeking an experienced translational and biomarker scientist and dynamic leader. Reporting to the Director of Translational Sciences, this individual will be responsible for helping to establish and expand the company’s capabilities for preclinical and clinical biomarker discovery and development to support therapeutic programs in multiple indications. They will also manage a team of external CROs to execute biomarker discovery and development strategies. The incumbent will be responsible for the development and conduct of in vitro, in vivo, and/or ex vivo studies to support and advance Septerna’s drug discovery pipeline. They will work both independently, hands-on as needed, and collaboratively as part of a matrixed inter-disciplinary team to establish the therapeutic mechanism of action of Septerna’s novel and differentiated drug candidates. The successful candidate will be responsible for writing and reviewing reports as well as regulatory documents. They will lead biomarker discovery and development efforts and be responsible for the clinical biomarker strategy and its implementation. They will establish PD, efficacy, and safety biomarkers as appropriate to determine the clinical impact of Septerna drugs. They will help demonstrate the selectivity and efficacy of Septerna’s therapies in the clinic, enabling patient and indication selection, as necessary. The successful candidate will serve as the Translational Sciences lead on cross-functional research and development teams and have opportunities to lead programs from discovery through early development. They will have the opportunity to demonstrate their scientific leadership within the R&D organization, contributing biological, disease area, and clinical insights to projects as well as ideas for new therapeutic programs.
At Septerna, we are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work in a leadership role with talented individuals on the frontlines of therapeutic discovery and development. You will help move therapies from preclinical through clinical development, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team on the frontlines of innovative therapeutic development. The successful candidate will be motivated to discover new disease-modifying therapeutics for patients and enjoy working in a fast-paced dynamic team environment.The position is based in South San Francisco, CA. Title and compensation commensurate with experience.
Key Responsibilities
include but are not limited to:
Design and execute in vitro, in vivo, and ex vivo studies to develop and implement translational biomarker strategies to advance therapeutic programs.
Generate, analyze, and interpret complex data to establish functional PK/PD, efficacy, and safety relationships and elucidate therapeutic mechanism of action for leads.
Serve as Translational Sciences lead on project teams, conduct and troubleshoot experiments, analyze and interpret data and work cross-functionally with colleagues to identify and mitigate risks and effectively advance therapeutic programs.
Help build biomarker discovery and development capabilities within the Translational Sciences group.
Author and review protocols, study reports, and regulatory documents to enable IND and other regulatory filings.
Follow all company policies/practices, and maintain accurate records and notebooks.
REQUIRED EDUCATION, SKILLS & EXPERIENCE
PhD in Endocrinology, Pharmacology, Toxicology, Immunology / Inflammation, or Metabolic Disease, or related biological science.
At least 5 years direct hands-on experience in therapeutic development leveraging (complex) in vitro and in vivo disease models for biomarker discovery and development in biotechnology and pharmaceutical industries.
Ability to be hands-on and work in the lab, write protocols, and execute studies leveraging Septerna in-house capabilities or working with CROs.
Direct experimental experience with pharmacology models or disease biology and demonstrated expertise in PK/PD, efficacy, and cell and tissue-based biomarker discovery.
Direct experience in analysis and interpretation of multi-omics and complex data sets such as bulk or scRNAseq to inform biomarker discovery and therapeutic MOA.
Experience with clinical biomarker development (pharmacodynamic, predictive, and safety) to inform clinical translation and patient selection strategies.
Experience working on/leading project teams with functional responsibility to analyze, interpret, and present complex data to inform strategic decisions.
Ability to collaborate in writing protocols, reports, and regulatory documents.
Experience working with vendors and CROs to execute studies, analyze biomarker data, and generate formal reports.
Experience authoring in vivo study protocols, reports, and/or regulatory documents including IND filings, CSRs, and/or NDAs.
Outstanding communication skills with demonstrated ability to make effective presentations in a broad range of settings.
Detail-oriented and organized, with strong interpersonal skills for clear and effective communication – ability to proactively engage and collaborate with colleagues for effective decision-making in a fast-paced, team-oriented environment.
PREFERRED SKILLS & EXPERIENCE
Experience with therapeutic programs which have yielded drugs entering clinical development in one or more of the following therapeutic areas: endocrinology, Immunology / Inflammation, or Metabolic Disease.
Experience working with complex cell-based systems or ex vivo models or patient samples to generate multi-omic data. Establish workflows, use Jupyter notebook or other platform to perform bioinformatics analysis and interpret and visualize complex data sets a plus.
Previous work leading a program in therapeutic discovery/development or toxicology.
Strong statistical analysis skills and an ability to articulate findings and make recommendations from complex study results.
Experience mentoring scientists, leading cross-functional project teams, and a track record of successful management of external teams.
The anticipated salary range for candidates who will work in South San Francisco, CA is $140,000 - $160,000. 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.
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We are seeking an experienced translational and biomarker scientist and dynamic leader. Reporting to the Director of Translational Sciences, this individual will be responsible for helping to establish and expand the company’s capabilities for preclinical and clinical biomarker discovery and development to support therapeutic programs in multiple indications. They will also manage a team of external CROs to execute biomarker discovery and development strategies. The incumbent will be responsible for the development and conduct of in vitro, in vivo, and/or ex vivo studies to support and advance Septerna’s drug discovery pipeline. They will work both independently, hands-on as needed, and collaboratively as part of a matrixed inter-disciplinary team to establish the therapeutic mechanism of action of Septerna’s novel and differentiated drug candidates. The successful candidate will be responsible for writing and reviewing reports as well as regulatory documents. They will lead biomarker discovery and development efforts and be responsible for the clinical biomarker strategy and its implementation. They will establish PD, efficacy, and safety biomarkers as appropriate to determine the clinical impact of Septerna drugs. They will help demonstrate the selectivity and efficacy of Septerna’s therapies in the clinic, enabling patient and indication selection, as necessary. The successful candidate will serve as the Translational Sciences lead on cross-functional research and development teams and have opportunities to lead programs from discovery through early development. They will have the opportunity to demonstrate their scientific leadership within the R&D organization, contributing biological, disease area, and clinical insights to projects as well as ideas for new therapeutic programs.
At Septerna, we are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work in a leadership role with talented individuals on the frontlines of therapeutic discovery and development. You will help move therapies from preclinical through clinical development, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team on the frontlines of innovative therapeutic development. The successful candidate will be motivated to discover new disease-modifying therapeutics for patients and enjoy working in a fast-paced dynamic team environment.The position is based in South San Francisco, CA. Title and compensation commensurate with experience.
Key Responsibilities
include but are not limited to:
Design and execute in vitro, in vivo, and ex vivo studies to develop and implement translational biomarker strategies to advance therapeutic programs.
Generate, analyze, and interpret complex data to establish functional PK/PD, efficacy, and safety relationships and elucidate therapeutic mechanism of action for leads.
Serve as Translational Sciences lead on project teams, conduct and troubleshoot experiments, analyze and interpret data and work cross-functionally with colleagues to identify and mitigate risks and effectively advance therapeutic programs.
Help build biomarker discovery and development capabilities within the Translational Sciences group.
Author and review protocols, study reports, and regulatory documents to enable IND and other regulatory filings.
Follow all company policies/practices, and maintain accurate records and notebooks.
REQUIRED EDUCATION, SKILLS & EXPERIENCE
PhD in Endocrinology, Pharmacology, Toxicology, Immunology / Inflammation, or Metabolic Disease, or related biological science.
At least 5 years direct hands-on experience in therapeutic development leveraging (complex) in vitro and in vivo disease models for biomarker discovery and development in biotechnology and pharmaceutical industries.
Ability to be hands-on and work in the lab, write protocols, and execute studies leveraging Septerna in-house capabilities or working with CROs.
Direct experimental experience with pharmacology models or disease biology and demonstrated expertise in PK/PD, efficacy, and cell and tissue-based biomarker discovery.
Direct experience in analysis and interpretation of multi-omics and complex data sets such as bulk or scRNAseq to inform biomarker discovery and therapeutic MOA.
Experience with clinical biomarker development (pharmacodynamic, predictive, and safety) to inform clinical translation and patient selection strategies.
Experience working on/leading project teams with functional responsibility to analyze, interpret, and present complex data to inform strategic decisions.
Ability to collaborate in writing protocols, reports, and regulatory documents.
Experience working with vendors and CROs to execute studies, analyze biomarker data, and generate formal reports.
Experience authoring in vivo study protocols, reports, and/or regulatory documents including IND filings, CSRs, and/or NDAs.
Outstanding communication skills with demonstrated ability to make effective presentations in a broad range of settings.
Detail-oriented and organized, with strong interpersonal skills for clear and effective communication – ability to proactively engage and collaborate with colleagues for effective decision-making in a fast-paced, team-oriented environment.
PREFERRED SKILLS & EXPERIENCE
Experience with therapeutic programs which have yielded drugs entering clinical development in one or more of the following therapeutic areas: endocrinology, Immunology / Inflammation, or Metabolic Disease.
Experience working with complex cell-based systems or ex vivo models or patient samples to generate multi-omic data. Establish workflows, use Jupyter notebook or other platform to perform bioinformatics analysis and interpret and visualize complex data sets a plus.
Previous work leading a program in therapeutic discovery/development or toxicology.
Strong statistical analysis skills and an ability to articulate findings and make recommendations from complex study results.
Experience mentoring scientists, leading cross-functional project teams, and a track record of successful management of external teams.
The anticipated salary range for candidates who will work in South San Francisco, CA is $140,000 - $160,000. 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.
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