Gossamer Bio is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology. Our goal is to create a business that allows value creation and capture at the individual asset level, long-term sustainability, and continuity, while ultimately helping to improve the lives of patients.
This position will support our rich pipeline of drug discovery, IND-enabling, and clinical programs. The focus of the Associate Director, DMPK will be to lead ADME support across the drug discovery and development portfolio. This position will collaborate, align and influence cross-functional teams to identify and mitigate key project questions related to PK, metabolism, assessment of DDI risk, support of IND-enabling ADME and toxicology efforts in addition to supporting PK/PD studies and human dose projection calculations.
Essential Duties and Responsibilities
- Guide DMPK activities across multiple drug project phases, including lead discovery, lead optimization, and regulatory filings.
- Supervise a DMPK team focused on the preclinical support of drug programs.
- Participate in the selection and management of CROs for the conduct of in vitro/in vivo ADME studies, including IND-enabling studies and studies to support clinical development.
- Partner with and support Medicinal Chemistry, Toxicology, Regulatory, Clinical, Project Management, and other departments by
- implementing ADME strategies that meet regulatory requirements and program goals.
- Accountable for developing a cutting-edge infra-structure including in-house capabilities that leverage automation and robotics, electronic lab notebooks, and collaborative IT tools.
- Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of drug candidates.
- Oversee the analysis, interpretation, integration, and reporting of preclinical DMPK data generated both internally and with external vendors.
- Provide expertise in human PK and dose prediction of drug candidates using different approaches.
- Author high-quality regulatory documents including INDs, CTAs, and other regulatory filings.
- PhD in Drug Metabolism, Pharmacokinetics, Chemistry, or related scientific discipline with a minimum of 4+ years of biotech/pharmaceutical drug discovery and development experience; or BS/MS with 8+ years of experience.
- Experience in serving as the lead ADME/PK representative on discovery and lead optimization teams. Experience in applying DMPK concepts and principles to drug discovery and development.
- Strong knowledge of drug metabolism and pharmacokinetics principles.
- Ability to plan, organize, and critically assess and/or perform PK/PD data analyses.
- Knowledge of the latest in technological and regulatory advances in the DMPK arena and demonstrated strong interest and expertise in PK and physicochemical properties modeling techniques.
- Demonstrated capability to mentor junior scientists and manage in a matrix environment.
- Builds strong relationships with peers and partners outside of DMPK to enable high team performance.
- Excellent oral and written communication skills and an ability to influence.
- Office environment / Domestic and International travel may be necessary