Pliant Therapeutics is a clinical stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar for progress to address unmet medical needs for patients and physicians. The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules.
The Associate Director/ Director, Formulation Development will lead the drug product development function. Responsibilities will include leading, planning and managing the technical and business-related activities associated with drug product development and manufacturing of clinical formulations, primarily solid oral dosage forms, at contract development sites. The Associate Director/ Director, Formulation Development will report to the Head of Non-Clinical Development, and will work closely with a cross-functional team in a fast-paced high growth environment team to ensure progression of Pliant small molecules from discovery through development.
- Design and select enabling preclinical formulations for pharmacology and toxicology studies.
- Implement innovative enabling technologies as needed.
- Develop strategies and execute plans for drug product development from first time in human formulations through development of NDA ready formulations in accordance with timelines and requirements of overall development programs.
- Identify and qualify CMOs for Pliant programs, including analytical CMOs, manufacturing CMOs and packaging/labeling and distributors.
- Lead formulation and process development, technology transfer and clinical manufacturing activities at CMO sites. Lead analytical method development and stability assessments.
- Review and approve manufacturing documents, protocols and reports.
- Write technical reports and author CMC sections of regulatory submissions related to drug product from IND through NDA stage of development.
- Effectively participate in cross- functional team meetings from discovery through development.
- Deliver drug product to meet clinical program needs, on schedule and within budget.
- PhD in Pharmaceutical Science or related field
- 7+ years experience in pre-formulation and formulation development for small molecules, preferably solid dosage forms, 3+ years in managing outsourced development activities
- Must have experience in formulation and process development from early to late phase development.
- Good working knowledge of GMP requirements for drug product development and manufacturing.
- Solid understanding of ICH, FDA, EMA guidances in CMC and Quality areas
- Effective written and oral communication and interpersonal skills.
- Experience in building and leading a formulation group in pre-formulation, formulation development, and process selection and scale up, and oversight of GMP manufacturing of drug products.
- Excel in team settings with ability to think critically and work independently.