(Sr.) Director of CMC Program Management

Company: Radical
Location: San Diego
Posted on: September 19, 2023

Job Description:

Location If you can join us in our lab in San Diego or in our Burlingame office, that'd be wonderful. However we are open to all qualified candidates who may work remotely. About us Genesis Therapeutics is a pioneering AI Biotech company focusing on the discovery of novel drugs using unique approaches to both undrugged and underdeveloped targets with the goal of providing new treatments for patients with severe diseases.We raised a with lead investors Rock Springs Capital and T Rowe Price; as well as lead seed investor Andreessen Horowitz, together with Menlo Ventures and Radical Ventures. Genesis has announced two significant, multi-target collaborations with , and most recently with , the latter of which entailed a $20M upfront payment with a $670M total deal size. Genesis originated in in Vijay Pande's lab at Stanford, when it was joined by legendary drug hunters and biotech entrepreneurs (including Dr. Leonard Bell, founder and CEO of Alexion Pharmaceuticals, acquired by Astra Zeneca for $39Bn; and Peppi Prasit, storied chemist from Merck known for Vioxx, Arcoxia, Singulair, who then went on to found Amira Pharmaceuticals, acquired by BMS, and Inception Sciences). The company is making strong progress in expanding the domain of our AI technology with the advance of our pipeline of best-in-class and first-in-class programs, both internal targets and those in partnership with Genentech and Lilly. About the role We are seeking a dynamic and experienced strategic leader for a newly established role in CMC Program Management. The Director/Senior Director of CMC Program Management will be part of the Program Management Team and will serve as the point of contact for CMC project management. In this highly visible and cross-functional role, the successful candidate will partner with Global Program Team Leadership and CMC Project Teams to develop and execute integrated CMC development plans. This role is expected to integrate the CMC strategy with the overall program development strategy including critical path activities, risks and mitigation plans. Responsibilities

• Assume overall responsibility for the CMC project management within Project Management Team in support of global program and corporate goals
• Establish a close partnering relationship with CMC and other functional teams to ensure alignment and facilitation of efficient program execution
• Maintain primary responsibility for cross-functional CMC project team meetings, including scheduling, preparation of agendas and minutes, maintenance of timelines, action items and risk management information
• Ensure timely communication among CMC, Global Program Teams, and other stake holders to maintain alignment of CMC project strategies, timelines, and deliverables with overall global program goals
• Cooperate closely with CMC team to anticipate high-level potential risks and identify contingency and mitigation plans and enlists key people to resolve obstacles to expedite drug development process through all phases
• As appropriate, support CRO/CMO vendor selection process and serve as a point of contact for CROs and CMOs for outsourced CMC projects
• Develop internal CMC infrastructure
• Support program management function Requirements
  • Advanced degree in Science or Engineering
  • PMP certification preferred
  • 8+ years of experience in CMC pharmaceutical/biotechnology development area
  • 5+ years of demonstrated project management experience in CMC
  • Drug Development knowledge with understanding of interdependencies between functions relevant to the position which may include R&D, Manufacturing, Nonclinical and Clinical Development, Regulatory, Supply Chain, and Commercial
  • Understanding of product development life cycle and stage gates from development to commercial operations
  • Experience with US and Non-US Health Authority filings
  • Outstanding interpersonal skills to build and maintain strong relationships across Genesis Therapeutics and with collaborators at CROs/CMOs
  • Experience leading and facilitating project team meetings, cross-functional communication and decision making, and ensuring ongoing alignment with internal/external stakeholders
  • Proven ability to manage and influence multiple project activities and plans simultaneously
  • Ability to work effectively with cross-functional teams in a matrixed organization to accomplish goals

Keywords: Radical, San Diego , (Sr.) Director of CMC Program Management, Executive , San Diego, California