Associate Director/Director, DMPK

1 month ago

San Diego, California, United States Treeline Biosciences Full time

Associate Director/Director, DMPK:

About the role

The Director, DMPK is responsible for overseeing drug metabolism and pharmacokinetic (DMPK) studies to advance small molecule drug candidates from preclinical through clinical development. The ability to plan, execute, monitor, and interpret DMPK studies for advancing therapeutic candidates through all stages of discovery and development are crucial elements of this position. The Director DMPK will also be responsible for authoring relevant sections of key regulatory documents and should have a strong knowledge of best regulatory practices. Excellent interpersonal and communication skills are essential in this highly visible role to work effectively within the cross-functional program teams.

Responsibilities

  • Partner with medicinal chemists, biologists, and data scientists to contribute to optimization and the identification of high-quality development candidates.
  • Provide input for addressing ADME issues in lead compounds and lead series in drug discovery.
  • Design and oversee external preclinical DMPK studies to understand pharmacokinetics (PK) and absorption, metabolism, distribution, excretion (ADME), and in vitro drug-drug interaction properties of lead compounds.
  • Build and provide predictions of human PK and pharmacologically active dose based on nonclinical data.
  • Represent DMPK as a subject matter expert to project teams by interpreting PK results and presenting conclusions to cross-functional program teams
  • Contribute to Module 2 and Module 4 sections of IND filings as well as IB and protocol
  • Directly interface with and manage contract research organizations (CROs) running PK and ADME studies, including gathering quotes, providing input during protocol development, monitoring timelines and data quality, reviewing data and study activities, and presenting data and conclusions to project teams
  • Maintain a current understanding of DMPK literature, methodology and regulatory requirements.
  • Participate on cross-functional project teams and contribute to interactions with global health authorities

Required Qualifications

  • D. pharmacokinetic/pharmaceutic science or related discipline or B.S./M.S. with extensive experience.
  • 8-10+ years of industry experience contributing DMPK/ADME insights to project teams and leading ADME/PK strategic decisions.
  • Experience selecting and managing CROs
  • Experience with preparation of the DMPK portions of regulatory documents such as pre-IND, IND, IB, briefing documents, and CTA while working in collaboration with cross functional team
  • Strong understanding of DMPK principles, the drug development process, and regulatory guidance to support DMPK and early clinical pharmacology strategies
  • Excellent time management, problem solving skills and ability to work and lead in a cross-functional setting.
  • Ability to exercise good judgment, strong analytical and organization skills, and attention to detail required.
  • Strong communication, interpersonal, collaboration and multi-tasking skills are required

Preferred Qualifications

  • Excellent knowledge and hands-on skills building translational PK/PD models is highly desirable
  • Experience with PK/PD and Modeling software (e.g., Phoenix WinNonLin, MATLAB/ Simbiology, PK Sim, Simcyp, or, background using NONMEM to develop PK/PD models) for optimization and selection of development candidates.

Treeline Biosciences is committed to protecting the health and safety of our team. Our company requires all employees to be fully vaccinated against COVID-19, including a booster shoot. Proof of vaccination must be provided prior to the first day of employment. As required by applicable law, Treeline will consider requests for Reasonable Accommodations.

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, DMPK

    4 weeks ago

    San Diego, California, United States Crinetics Pharmaceuticals, Inc Full time

    The Director, DMPK will report to the Vice President of DMPK and will primarily liaise with our highly dynamic Chemistry, Pharmacology, and Toxicology departments to develop strategies and advance discovery programs to the clinic.The individual should have strong scientific training in all areas of DMPK and a demonstrated track record of leading focused DMPK...

  • Senior Director, DMPK

    1 month ago

    San Diego, California, United States Vertex Pharmaceuticals, Inc Full time

    Vertex San Diego Drug Metabolism and Pharmacokinetics (DMPK) team is seeking a highly motivated, experienced scientist and leader Senior Director level to help advance discovery and development of transformational therapies for serious unmet medical needs.The Senior Director of Drug Metabolism & Pharmacokinetics will be part of the global DMPK and local site...

  • 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...

  • GUCCI Associate Store Director

    4 weeks ago

    San Diego, California, United States Gucci Full time

    If you are a Dream-maker, this is the place for you. Together, we'll create the real fabric of Gucci. A community of people united by the same passion: breaking new ground in the fashion world and beyond.Role MissionAs a Gucci Associate Store Director, you will effectively lead and support all activities to achieve store business objectives, demonstrate the...

  • Associate Director of Bands

    1 day ago

    San Jose, California, United States San Jose State University Full time

    Associate Director of Bands Job no: Work type: Visiting Faculty Location: San José State University, San José, California Compensation: Commensurate with qualifications, experience, and rank as established by the CSU Salary Schedule . See Benefits Summary for details about the CSU's excellent employment benefits. Anticipated salary: Job...

  • Director of Food

    1 month ago

    San Diego, California, United States Hotel Republic San Diego Full time

    Crescent Hotels & Resorts is seeking a Director of Food & Beverage for the Hotel Republic, located in the heart of downtown San Diego. This vibrant and sophisticated boutique hotel offers a unique blend of modern luxury and local charm. As part of the Autograph Collection, each aspect of Hotel Republic is thoughtfully crafted to reflect the distinctive...

  • Gucci Associate Store Director – San Diego

    1 day ago

    San Diego, California, United States GUCCI Full time

    Role MissionAs a Gucci Associate Store Director, you will effectively lead and support all activities to achieve store business objectives, demonstrate the unsurpassed service culture and take responsibility for human resource management, while driving associate development. You will perform with high integrity in operations and loss prevention compliance,...

  • Associate Director Biostatistics

    4 weeks ago

    San Francisco, California, United States Proclinical Full time

    Associate Director Biostatistics - Permanent - RemoteProclinical Staffing is seeking an Associate Director Biostatistics to join a cutting-edge pharmaceutical company. This is a permanent role with the opportunity to work remotely.Primary ResponsibilitiesThe Associate Director, Biostatistics is responsible for statistical activities in support of clinical...

  • Director / Senior Director, Computational Chemistry

    1 month ago

    San Diego, California, United States X4lifesciences Full time

    With a focus on leveraging cutting-edge machine learning and interdisciplinary approaches, they are committed to advancing drug discovery and development to improve patient outcomes worldwide.We are seeking a highly experienced and motivated Director/Senior Director of Computational Chemistry to lead a team of computational scientists in their world class...

  • Director, Computational Chemistry

    4 weeks ago

    San Diego, California, United States Biopharma Company Full time

    As the ASSOCIATE/DIRECTOR, COMPUTATIONAL CHEMISTRY, you will work as part of a multi-disciplinary team of Medicinal Chemists, Computational Chemists, Structural biologists, Pharmacologists and Biologists to provide Computational expertise to advance drug discovery projects.You will contribute to drug discovery efforts across various modalities including...

  • Assistant Director of Engineering

    1 week ago

    San Diego, California, United States Marriott International Full time

    Job Number Job Category Engineering & FacilitiesLocation San Diego Marriott Gaslamp Quarter, 660 K Street, San Diego, California, United States VIEW ON MAP Schedule Full-TimeLocated Remotely? NRelocation? NPosition Type Management Additional Information: This hotel is owned and operated by an independent franchisee, Stanford Hotel Corporation. The franchisee...

  • Director of Revenue Management

    1 month ago

    San Diego, California, United States Hotel Republic San Diego Full time

    Crescent Hotels & Resorts is seeking a Director of Revenue Management for the Hotel Republic, located in the heart of downtown San Diego. This vibrant and sophisticated boutique hotel offers a unique blend of modern luxury and local charm. As part of the Autograph Collection, each aspect of Hotel Republic is thoughtfully crafted to reflect the distinctive...

  • 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 Director, Clinical Pharmacology

    6 days 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...

  • Sales Director

    1 month ago

    San Diego, California, United States Redeployment Full time

    We are looking for a results-driven and ambitious sales leader to make a significant impact on our journey to new heights.As the Sales Director, you will play a pivotal role in driving revenue growth, fostering strategic partnerships, and shaping the future of our client's organization.Utilize your extensive SaaS sales experience to enhance the national...

  • Area Associate Director of Finance

    1 month ago

    San Francisco, California, United States Sage Hospitality Group Full time

    Why us?Sage Hospitality Group is seeking an Area Associate Director of Finance supervise and coordinate the accounting operations for Hotel Zeppelin and Hotel Zetta in beautiful San Francisco, CAABOUT OUR HOTELSHotel Zeppelin , retreat to a bold, bohemian salute to the rebels, revolutionaries, and rock 'n rollers who shaped the San Francisco we know and...

  • GUCCI Store Director

    4 days ago

    San Diego, California, United States Gucci Full time

    If you are a Dream-maker, this is the place for you. Together, we'll create the real fabric of Gucci. A community of people united by the same passion: breaking new ground in the fashion world and beyond.Role MissionAs a Gucci Store Director, you will lead and support all activities to achieve store business objectives, demonstrating an unsurpassed service...

  • Director of Finance

    2 days ago

    San Diego, California, United States Hotel Republic San Diego Full time

    Crescent Hotels & Resorts is seeking a Director of Finance for the Hotel Republic, located in the heart of downtown San Diego. This vibrant and sophisticated boutique hotel offers a unique blend of modern luxury and local charm. As part of the Autograph Collection, each aspect of Hotel Republic is thoughtfully crafted to reflect the distinctive character of...

  • Director of Campus Operations

    6 days ago

    San Francisco, California, United States Sterne School Full time

    The Director of Campus Operations reports to the Director of Finance & Business. Responsibilities include but are not limited to: Partnering with the Director of Finance to develop short- and long-term strategies to keep the campus operating at the most efficient and cost-effective levels Acting as a thought partner with the Director of Finance and Head of...

  • Director of Business Development

    1 month ago

    San Diego, California, United States Kuraray America, Inc Full time

    Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.S/he ensures new opportunities are generated and new bookings (contracts) are won for Eurofins Pharma Bioanalytical Services.S/he reports to the Senior...