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.
We are looking for a DMPK Associate Director/Director to support Gossamer’s rich pipeline of drug discovery, IND-enabling, and clinical programs. The focus of the DMPK Associate Director/Director will be to lead ADME contributions across Gossamer’s drug discovery and development portfolio. This position will collaborate with and influence cross-functional teams to identify and mitigate challenges related to PK, metabolism, assessment of DDIs, IND-enabling ADME, toxicology, PK/PD studies, and human dose projections. Additionally, this role will assist with the development of scientific strategies and continue to build partnerships cross-functionally to advance both Gossamer’s research and clinical programs.
Essential Duties and Responsibilities
- Guide DMPK activities across multiple 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 and 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 program goals and regulatory requirements.
- Develop 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 PK and ADME of drug candidates.
- Oversee the analysis, interpretation, integration, and reporting of preclinical DMPK data generated both internally and using external vendors.
- Provide expertise in human PK and dose prediction of drug candidates using different approaches.
- Author high-quality regulatory documents including INDs, CTAs, NDAs, and other regulatory filings.
- Ph.D. in Drug Metabolism, Pharmacokinetics, Pharmaceutical Chemistry, or a related scientific discipline, with a minimum of 8+ years of biotech/pharmaceutical drug discovery and development experience.
- Experience in serving as the lead ADME/PK representative on discovery, lead optimization and development teams, and applying DMPK concepts to the function of those teams.
- 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 technological and regulatory advances in the DMPK arena and demonstrated strong interest and expertise in PK and physicochemical property modeling techniques.
- Demonstrated capability to mentor junior scientists and manage in a matrix environment.
- Build 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.
- This position is onsite and based in San Diego, CA.
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.
US Vaccination Policy:
Gossamer Bio is committed to complying with federal, state and local law on employee vaccinations. Job candidates and employees should be aware that full vaccination against COVID-19 is required. Gossamer Bio is an equal opportunity employer, and will provide reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
California Consumer Privacy Act (CCPA) Notice for California Residents:
This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3013 Science Park Road, Suite 200, San Diego CA 92121 and can be contacted by emailing [email protected], because Controller wishes to evaluate your candidacy for employment at Controller.
Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment. Controller’s Privacy team can be contacted at [email protected]
Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.
Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf.
Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with a supervisory authority.