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 lead author and key 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 insure 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.
• 8+ 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 Healthy 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.

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is $230K – $240K. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.