Associate Director, Clinical Pharmacology South San Francisco, CA
Pliantrx, San Francisco, CA, United States
Associate Director, Clinical Pharmacology
Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. As the leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, Pliant is developing small molecule drug candidates specifically designed to impact the fibrotic process.
The Company’s lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC). Pliant is currently conducting BEACON-IPF, a Phase 2b/3 trial of bexotegrast for the treatment of IPF.
Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors.
Description
The Associate Director of Clinical Pharmacology will be based in South San Francisco and report to the Senior Director, Head of Clinical Pharmacology. He/she will be responsible for the development of the strategic, scientific, translational and clinical development aspects of clinical pharmacology development plans across multiple indications. He/she will define key milestones and decisions, identify risks and mitigation strategies, provide input to modeling and simulation plans and the interpretation of pharmacokinetic/pharmacodynamic data from Phase 1 to 4 studies.
This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).
Responsibilities
- Serve as the study director for Phase 1 studies including first-in-man, biopharmaceutics, drug-drug interactions, special populations, and proof-of-pharmacology/concept studies, and be accountable for timely and high-quality execution of all clinical studies under his/her responsibility in the Pliant Portfolio.
- Provide functional representation at project team meetings, seek input from and ensure alignment with cross-functional partners, consultants, experts and vendors, as needed.
- Act as author and contributor to develop clinical pharmacology sections of clinical and regulatory documents including clinical protocols and study reports, statistical analysis plans, IND and IMPD submissions, regulatory briefing documents, pediatric investigational plans, NDA and/or MAA submissions, and represent clinical pharmacology during regulatory interactions.
- Work in close cross-functional collaboration with Clinical Operations, Regulatory Affairs, Program Management, Quality Assurance, Biometrics and Data Management, Pharmacovigilance and Clinical Research Organizations (CROs).
- Act as Study Director and lead clinical pharmacology studies with varying degrees of complexity.
- Represent the clinical pharmacology function and provide subject matter expertise on cross-functional project teams, including the study execution team (SET) and the clinical study team (CST).
- Develop high-quality clinical pharmacology plans and author related content for global regulatory submissions, including INDs, IMPDs, CTAs, IBs, NDAs, MAAs and pediatric investigational plans.
- Provide scientific input into the study rationale and design, author/review/approve clinical protocols and statistical analysis plans, interpret pharmacokinetic and pharmacodynamic data for study reports and regulatory submissions.
- Establish and develop working relationships with contract research organizations and bioanalytic vendors and provide clinical pharmacology oversight.
- Identify, develop, and manage vendors for population PK, PK/PD, and PBPK modeling.
- Ensure that Phase 1 clinical studies are conducted in compliance to GCP, company SOPs, governing laws, and regulations.
- Ensure adherence to agreed timelines and budgets to ensure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.
- Maintain the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
- Identify and implement clinical pharmacology tools and technologies to drive smarter drug development for programs.
- Attend meetings with external stakeholders (investigator meetings, clinical/scientific advisory boards) and health authorities, as needed.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.
- PhD degree in pharmaceutics, pharmacokinetics, pharmacology, or related discipline.
- 6+ years of biotech/pharma drug development experience with deep expertise in clinical pharmacology.
- Excellent working knowledge of clinical pharmacology (pharmacokinetics, pharmacodynamics, translational medicine) and drug development principles.
- In depth knowledge of population PK, PK/PD, PBPK modeling concepts, data analysis, and interpretation with demonstrated record in applying these concepts to support clinical development programs.
- Hands on modeling and simulation experience.
- Experience with pharmacokinetics for small and large molecules (e.g., monoclonal antibody).
- Track record of formulating, integrating and translating clinical pharmacology strategies into actionable deliverables.
- Direct experience leveraging modeling and simulation to facilitate compound development and registration with a sound understanding of the technical aspects of modeling and available software (e.g., NONMEM, WinNonLin, S-Plus/R, etc.) used for analysis.
- Strive for continuous improvement and embrace innovative ideas in daily work.
- Good working knowledge of FDA, EMA and ICH regulations and ability to incorporate relevant regulatory requirements into development plans, study design and ensure adherence to regulations, including GCP requirements during study conduct.
- Regulatory experience (i.e., INDs, NDAs, BLAs, etc. submissions, responses to Health Authority queries, direct interaction with Health Authorities).
- High degree of organizational awareness, ability to connect the dots to understand the interdependencies and see the big picture.
- Ability to interpret and communicate complex scientific concepts in a concise and clear manner to an audience with various levels of expertise to ensure scientific input is incorporated into strategic decision-making.
- Confidence and ability to present to senior leaders and influence decision-making within the organization.
- Self-motivated, able to work in cross-functional global teams in a dynamic, fast-paced, and collaborative environment.
- Strong work ethic and a high degree of professional integrity.
- Excellent written and oral communication skills.