Associate Director CMC Program Strategy - Redwood City , California, United States, 94061

We're looking for a candidate to fill this position in an exciting company.

  • Represents all CMC areas on the AST serving as spokesperson for the product presentation and device team (PPDST) and ensures information flow among the AST and all line functions.
  • Ensures high quality science, technology, deliverables, and certifies compliance with global regulatory and quality requirements. Participates in meetings with Regulatory Authorities, responds urgently to regulatory queries, and participates in Pre-Approval Inspections.
  • Proficient with legal and financial aspects of outsourcing, contracts, and statements of work (SOW).
  • Demonstrate excellent interpersonal skills, ability to develop important relationships with external collaboration partners and key internal stakeholders.
  • Demonstrate strong negotiating, influencing, and leadership skills.
  • Lead teams and partner interactions for new due diligence in-licensing opportunities and successfully transition leadership for programs where development is internalized.
  • Manages a limited number of projects of low complexity utilizing matrix management approach.
  • Negotiates for additional resources when required, influences project timelines to ensure proper completion of required activities.
  • Implements creative approaches to conserve resources, and achieve efficiency with respect to time, and budget.
  • Provides feedback and input to functional managers and identify growth needs for team members.
  • Reviews contracts with Third Party Manufacturers and consultants.
  • Develops an often-significant budget in collaboration with AST, obtains resources from functional areas and stays within the approved funding.
  • Accountable for the success and overall CMC quality of a given project.
  • Ensure timely execution of high-quality deliverables with respect to science, technology, compliance and cost effectiveness.
  • Lead CMC development teams for assigned projects: schedules meetings, develops agendas, issues highlights, apprise risks and plans with CMC Management, conduct periodic reviews, to ensure that phase transition criteria are met in the most efficient and resource sparing manner.
  • Support and implement corporate and divisional initiatives and strategies.
  • Promote scientific and entrepreneurial thinking, encourage creativity and manage quality and results with respect to science, time, budget and resources.
  • Integrate and implement a pre-clinical development plan and update as necessary in collaboration with the global development team and respective line functions.
  • Ensures compliance with regulatory, health, safety and environmental requirements.
  • Stay abreast of developments in global technical, regulatory and compliance arena and industry practice.
  • Apprise CMC Management of plans and risks through regular communications, periodic reviews, in support of global filings, approvals and launches.
  • Responsible for the global filings of high-quality CMC dossiers, approval and commercialization of products.
  • Bachelor's Degree with at least 10 years of experience in a variety of CMC functions required; Master's
  • Degree with at least 8 years of relevant CMC experience required; or PhD with at least 6 years of relevant
  • CMC experience required to effectively manage global teams and all CMC activities with respect to science, technology, quality, regulatory/compliance requirements, budget and resources.
  • Must possess good scientific writing skills and good verbal skills.
  • Must have a good working knowledge of regulatory requirements and familiarity with relevant research instrumentation and techniques.
  • Knowledge of pharmaceutical theory and the drug development process.
  • Must have CMC interdisciplinary experience and expertise.
  • Possess negotiating, influencing, leadership skills.
  • Creative in implementing entrepreneurial thinking and make smart business decisions.
  • Ensure high level of morale in the CMC team.