The Senior 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 phase appropriate formulation development and drug product process development. This role provides scientific expertise in solid oral dosage formulation and drug product development, oversight of GMP drug product manufacturing at contract development sites, authoring global regulatory filings (INDs, IMPDs, etc.) and technical oversight of preclinical formulation development. The Senior Director, Formulation Development will report to the Sr. Vice President, CMC and 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, approval and launch. In addition, The Sr Director, Formulation Development is expected to significantly contribute to all aspects of the CMC strategy and work closely with Chemical Development, Analytical Development, Supply Chain, Technical and Global Program Leads, Quality, Regulatory, and Nonclinical to support Pliant’s development program strategy through NDA and approval and life cycle management.

This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco).

Responsibilities

• Provides guidance, coaching, and leadership aligned with corporate goals and company culture to a team of scientists and engineers in support of drug product development and optimization, and manufacturing at Pliant. Retains and recruits key talent as necessary.
• Working closely with the Heads of Chemical and Analytical Development, is responsible for the technical content of regulatory briefing packages and responses to regulatory authority questions and NDA readiness activities. Working closely with Heads of Chemical and Analytical Development, and Regulatory Affairs, is responsible for sections of the Quality module of the NDA, associated amendments, and post approval filings, globally.
• Serves as an SME for oral solid dosage form development and manufacturing.
• Design and select enabling preclinical formulations for pharmacology and toxicology
• Oversee the strategy and execution of development and characterization studies to evaluate formulations, primary container closure systems, and drug product manufacturing unit
• Develop strategies and execute plans for drug product development from first time in human formulations through development and launch in accordance with timelines and requirements of overall development programs.
• Identify vendors to support drug product development and GMP manufacturing of clinical supplies and commercial products.
• Lead formulation and process development, technology transfer, scale-up, and clinical manufacturing activities at CMO
• Works closely with Analytical Development to ensure development and validation of phase-appropriate methods and reviews and assesses stability studies outputs.
• Review and approve manufacturing documents, protocols, and
• Work closely with the Head of Supply Chain to ensure continuous supplies to clinical studies
• Working closely with Quality, establishes and/or improves standard operating procedures as they relate to key CMC processes. Contributes to building the QMS.
• Fosters strong ties with Quality team. Supports change control and quality impact assessments.
• Support due diligence and business development opportunities.
• Actively engages in creating a positive and transparent culture with key internal team members, stakeholders (Quality, Regulatory, Nonclinical, Research) and external customers, vendors and future partners.
• Mentors staff and teams. Maintain a positive culture of technical excellence, collaboration, transparent and redundant communication, employee development, and goal achievement. Develop leaders by providing an environment that encourages ongoing personal and professional development. Ensure staff receives appropriate knowledge, skill development and growth opportunities.
• Accountable for developing and managing function resources and budgets
• Ensures timely documentation of technical information; Writes and reviews technical reports and author CMC sections of regulatory submissions related to drug product from IND through NDA stage of development.

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 in Pharmaceutical Science or related
• 10+ years’ experience in pre-formulation and formulation development for small molecules, preferably solid dosage forms, 5+ years in managing outsourced development activities.
• Must have experience in formulation and process development from early to late phase development and NDA filing.
• Good working knowledge of GMP requirements for drug product development and
• Solid understanding of ICH, FDA, EMA guidance’s in CMC and Quality
• Effective written and oral communication and interpersonal
• 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
• Excel in team settings with ability to be agile, think critically, and work

The annual base salary for this role is $270K – $280K. 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.