Senior Manager, DMPK

5 days ago

San Diego, California, United States Treeline Biosciences Full time

Senior Manager, DMPK and Toxicology Operations

The ideal candidate will have a track record of partnering successfully with external Contract Research Organizations (CRO) on DMPK and Toxicology studies to ensure that contracted studies are completed on time and that data are of high quality. In addition, this candidate will be responsible for ensuring that various Treeline dashboards and internal data platforms ingest the data accurately. This role requires excellent communication, organization, and scientific understanding of drug metabolism, pharmacokinetics, and toxicology to support project success. A candidate for this role will have experience with identifying, establishing, negotiating, and maintaining CRO relationships and commitments; specifically, for both in vitro and in vivo investigations in discovery through IND-enabling studies. Additionally, this individual will have experience working with cross-functional teams in chemistry, biology, translational sciences, along with DMPK and toxicology and finding solutions necessary to meet timelines that support program success.

Role objective:

  • Identify and manage business relationships with Contract Research Organizations (CROs). Responsibilities include cost negotiation and issue resolution.
  • Manage external operations personnel and vendors where needed in discovery DMPK and Toxicology to ensure that timelines are met, and data are high quality.
  • Manage Regulated (GLP) and non-GLP nonclinical discovery and development studies at Contract Research Organizations (CROs) to ensure that timelines are met, and data are high quality.
  • Regularly review performance of CROs to ensure that Treeline is working with leading CROs and that CROs are meeting the contracted objectives (KPIs). Track, prepare, and share budget analysis to Project management and finance departments, as requested.
  • Partner with data engineers and IT to develop and maintain web-based in vitro and in vivo study tracker and data archiving tool. Efforts will be aimed at streamlining protocol generation and ordering.
  • Partner with scientists, Project Management, IT, and data scientists to ensure that data generated by CROs are ingested accurately into various Treeline platforms. Responsible for working with CROs and data scientists to resolve instances where data cannot be processed.

Role accountabilities:

  • Author in vivo and in vitro protocols and amendments with internal and external partners
  • Review study-related documents (scope of work, protocols, amendments and reports) for completeness, accuracy and consistency with relevant regulatory guidance documents/regulations
  • Facilitate DMPK and Toxicology activities collaborating with multiple groups across Treeline (Toxicology, DMPK, Project Management, Chemistry, and Translational scientists)
  • Maintain study correspondence with CROs and relevant internal personnel for assigned DMPK and tox studies. Provide regular updates on timelines for studies. Escalate issues and work with CRO partners to resolve issues.
  • Build and generate CRO templates for Treeline database ingestion
  • Review and QC CRO generated in vitro and in vivo data and ensure ingestion of the reviewed data into the Treeline database
  • Ensure draft and final nonclinical protocols and reports are maintained in appropriate electronic document storage system.
  • Ensure finalization and submission readiness of nonclinical program reports
  • Assist with study planning and protocol development activities in collaboration with project teams
  • Ensure timelines for study initiation, study readout and data/report finalization are met
  • Develop department standard operating procedures to ensure high and consistent level of quality
  • Track reporting deliverables and upload or graph real-time data

Role Knowledge and Skills:

  • Possess knowledge of FDA Good Laboratory Practice (GLP) Regulations as set forth in 21 CFR Part 58, OECD and ICH guidelines
  • Experience with CRO management
  • Experience with the design and conduct of non-regulated and regulated nonclinical studies
  • Experience with Phoenix WinNonLin, Prism, Excel/MS Office, and study LIMS software and interfaces.
  • BA or BS with a minimum or 7 years of experience in a DMPK or toxicology strategic operations support role

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in San Diego is $175,898 to $195,524. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.

Recruitment fraud statement

Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:

  • Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
  • We do not conduct interviews through Skype or Telegram.
  • Our job openings are first posted to If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.
  • You can find more information about job scams at
  • To report job scams, head to
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters)

The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.

  • Director/Senior Director of DMPK

    4 weeks ago

    San Diego, California, United States Genesis Therapeutics Full time

    Genesis Therapeutics is pioneering artificial intelligence guided rational drug design to address severe unmet medical needs for patients. Our lab in San Diego is looking for an experienced, motivated, and versatile Drug Metabolism and Pharmacokinetics (DMPK) Director or Senior Director to lead of DMPK team and to help advance our compounds through...

  • Associate Director/director, Dmpk

    2 weeks ago

    San Diego, California, United States Kumquat Biosciences Inc Full time

    :Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founder to translate innovative research to novel therapeutics. Our team has a proven track record of drug discovery and development, having played pivotal...

  • Advisor - DMPK

    4 weeks ago

    San Francisco, California, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Director, DMPK

    4 weeks ago

    San Francisco, California, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate Director, Clinical Pharmacology and DMPK

    2 weeks ago

    South San Francisco, California, United States Alumis Inc Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. This position is a key member of the development...

  • Associate Director, Clinical Pharmacology and DMPK

    2 weeks ago

    South San Francisco, California, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. This position is a key member of the...

  • Associate Director, Clinical Pharmacology and DMPK

    7 days ago

    South San Francisco, California, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer – our goal is to fundamentally change the outcomes for these patients. This position is a key member of the...

  • Senior Research Scientist I, Drug Metabolism and Pharmacokinetics

    2 weeks ago

    San Mateo, California, United States GILEAD Sciences Full time

    For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of...

  • Corporate Contracts Manager

    2 weeks ago

    San Diego, California, United States St. Paul's Senior Services Full time

    JOB TITLE: Contracts and Credentialing Coordinator for St. Paul's Senior Services Manage outside vendor contracting services for St. Paul's Senior Services and St. Paul's PACE Oversee credentialing process for contracted providers to meet NCQA standards Supervise Contracts and Credentialing Coordinators Assist with quality assurance and performance...

  • Senior Engineering Manager

    2 weeks ago

    San Diego, California, United States IC Resources Full time

    Our client, a world-leading RISC-V Semiconductor IP company is seeking a Senior Engineering Manager to join them in San Jose, CA.Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.This company has achieved phenomenal success in recent years, with annual revenue tripling in size since 2018....

  • Corporate Contracts Manager

    4 weeks ago

    San Diego, California, United States St. Paul's Senior Services Full time

    San Diego's St. Paul's PACE program (Program of All-Inclusive Care for the Elderly). This innovative program is for individuals 55 years or older, who are living with chronic illness, or disabilities and need coordinated medical care to continue living as independently as possible in their home and community. The healthcare teams at St. Paul's PACE provide a...

  • Corporate Contracts Manager

    2 weeks ago

    San Diego, California, United States St. Paul's Senior Services Full time

    St. Paul's Bankers Hill, 328 MAPLE STREET, SAN DIEGO, California, United States of America Req #2337Tuesday, May 28, 2024 San Diego's St. Paul's PACE program (Program of All-Inclusive Care for the Elderly).This innovative program is for individuals 55 years or older, who are living with chronic illness, or disabilities and need coordinated medical care to...

  • Director of Clinical Pharmacology

    4 weeks ago

    San Diego, California, United States AnaptysBio, Inc. Full time

    Job TypeFull-timePosition SummaryThis position is a key member of the development team, executing clinical drug development activities and evaluating the clinical pharmacology of antibody therapeutics that are focused primarily on immune-inflammatory diseases. This position reports to the Clinical Pharmacology and Toxicology department head and liaises with...

  • Director of Clinical Pharmacology

    4 weeks ago

    San Diego, California, United States AnaptysBio Inc Full time

    AnaptysBio IncAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.Description:Position SummaryThis position is a key member of the...

  • Senior Care Manager

    2 weeks ago

    San Diego, California, United States Magellan Health Full time

    Senior Care Manager - Autism ABA - Remote in CAAuthorizes and reviews utilization of autism services, including Applied Behavioral Analysis (ABA).Collects and analyzes utilization data and interacts with other service providers.Collaborates with the ABA treatment team to develop care plans and ensure continuous progress monitoring.Provides guidance and...

  • Senior Project Manager

    2 weeks ago

    San Diego, California, United States Danaher Corporation Full time

    Leica Biosystems mission of Advancing Cancer Diagnostics, Improving Lives is at the heart of our corporate culture. Were a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know that...

  • Senior Project Manager

    4 weeks ago

    San Diego, California, United States Danaher Full time

    Leica Biosystems' mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of our corporate culture. We're a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know...

  • Senior Associate, Configuration Management

    2 weeks ago

    San Diego, California, United States L3Harris Technologies Full time

    The Configuration Management Analyst performs configuration and data management tasks, ensuring adherence to configuration management procedures and policies, as well as contractual requirements. This role documents and tracks all aspects of hardware Management, Configuration, Associate, Senior, ERP, Technology

  • Senior Director, Clinical Pharmacology

    4 weeks ago

    South San Francisco, California, United States Maze Therapeutics Full time

    The Position:At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join our Clinical Science team and take a central role in pioneering the future of...

  • Senior Project Manager

    4 weeks ago

    San Diego, California, United States Mace Full time

    At Mace, our purpose is to redefine the boundaries of ambition. We believe in creating places that are responsible, bringing transformative impact to our people, communities and societies across the globe. To learn more about our purpose, culture, and priorities, visit our strategy site. Within our consult business, we harness our unique combination of...