Director, CMC Project Management (Onsite in SSF - 3X/WK)

Pliant Therapeutics, Inc.•South San Francisco, CA

11h•$248,000 - $274,000•Onsite

About The Position

Pliant Therapeutics is a clinical-stage biopharmaceutical company and leader in the discovery and development of novel integrin-based therapeutics. Based in South San Francisco, California, Pliant was founded in 2015 to develop therapeutics to modulate specific pathways upregulated or dysfunctional in certain diseases. Our approach involves developing novel integrin-based therapeutics to treat solid tumors and other diseases. Integrins are a crucial link between a cell's internal structure and its external environment and function in cell signaling, regulation and adhesion as well as wound healing and immune response. Founded by a team of world-renowned researchers from the University of California, San Francisco, this group discovered key insights into the integrin biology and developed small molecule therapeutics to target this devastating disease process. Launched in 2016 by Third Rock Ventures, a leading healthcare venture capital firm, Pliant has developed an industry-leading proprietary library of over 15,000 integrins that serve as a key driver to its portfolio. We believe our platform may be broadly applicable across multiple disease areas including delivery of drug payloads to cells utilizing integrin receptor-binding molecules as tissue-specific delivery and internalization mechanisms. Currently, Pliant is conducting a Phase 1 study of PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that has shown encouraging clinical activity in the development of a treatment of immune checkpoint resistant solid tumors. Description The Director, CMC Project Management is a key development role in the CMC and Technical Operations organization. This position partners closely with Quality, Clinical Operations, Regulatory Affairs, Global Program and Project Management, Finance, Preclinical, and Business Development. This role supports all CMC development functions – including Drug Substance, Drug Product Development, Analytical Development – as well as manufacturing and supply chain in support of all Pliant development programs. This position is part of the CMC Technical Operations leadership team and reports to the Chief Technical Officer.

Requirements

BS/MS degree in Science, Engineering or a related field.
Minimum of 12 years of project management-related experience as either a designated project manager or PM responsibilities as part of a technical role, preferably in a small/medium sized biotech setting. Prior experience as a technical lead a plus.
Small molecule solid oral experience preferred.
Knowledge, understanding and direct application of project management best practices and proficiency with supporting project management tools; PMP certification a plus.
Knowledge of biotechnology/pharmaceutical product development: process development, analytical development, manufacturing, clinical supply chain, CMC regulatory filings, GMP manufacturing process. Working understanding of regulatory and clinical project management is also a plus.
Strong time management, planning, and organizational skills.
Demonstrated ability to prioritize and balance multiple competing tasks, plan realistic deadlines, and drive to completion.
Strong communication, leadership, and cross-functional collaboration skills.
Ability to thrive in a fluid environment, quickly adapting to new situations.

Responsibilities

Leads the CMC core team meetings under the mentorship of the Technical Project Lead and drives team to meet project deliverables on time and within budget.
Leads long-range planning (LRP) and budget activities in partnership with the CTO.
Partners with function heads to develop and monitor project timelines, budget, and associated tracking tools.
Raises awareness about the criticality of CMC activities to overall project success. Executes scenario planning, risk assessments, action logs as appropriate.
Manages CMC sub-team, and Contract Organization standing meetings, including agendas, minutes, and action items. Coordinate business review meetings with all key vendors.
Support the development of CMC strategies to meet business objectives for Pliant’s development projects, registration, NDA-readiness, and commercial launch.
Drives timely decisions and accountability within teams while facilitating active communication and information flow between peers, team members, stakeholder functions, and governance bodies. Escalate critical issues to appropriate stakeholders and governance bodies.
Establish and follow project management best practices including management of scope, requirements, risks, and long-range planning.
Contributes to CMC portfolio analysis to drive decision making and resource allocation/budgeting across functions.
Consults with project sponsors and stakeholders at all levels to determine goals, timelines, funding, resources, and procedures for accomplishing projects; Assess impact of project scope changes to CMC activities and manufacturing plans.
Establish and maintain positive relationships with stakeholders and team members.