Director, CMC Project Management
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 2505238
Job Description Summary
The Director, CMC Project Management (PM) will provide PM leadership to Technical Operations cross-functional teams (CMC teams) for assets that are in preclinical to commercial stage. The Director, CMC PM will closely collaborate with and complement the CMC technical Lead to ensure the CMC team develops strategies, plans, and delivers in agreement with cross-functional Asset Core Team goals.
Activities covered include, but are not limited to, Drug Substance (DS) process development and validation, Drug Product (DP) formulation, process development, and validation, analytical development and controls, technology transfer, CMC support to regulatory filings, life cycle management projects, and CMC Alliance management.
- Support the CMC Lead and functional representatives in the development and execution of the overall CMC strategy for assets in early and full development phases
- Establish and manage the CMC development plan, and integration into the Asset Development Plan; lead the CMC team through scenario planning and identify critical path activities
- Support the development of CMC team goals and Technical Operations department goals
- As a member of the CMC project management function, contribute to establishing PM processes and tools of highest quality, and the development, maintenance, and implementation of Technical Operations playbooks
- Lead CMC team budgeting and resourcing processes, track variance, and assess impact
- Ensure CMC team functional representatives contribute clearly defined activity scopes, deliverables, and timelines to the CMC development plan, and actively report to team on progress, risks, roadblocks, and proposed issue resolution
- Facilitate effective decision making by ensuring use of adequate processes and tools, and involvement of relevant stakeholders
- Ensure CMC team execution and completion of project tasks according to plan, and track progress toward achievement of CMC milestones and decision points
- Coordinate CMC team activities and act as the central core of project team information
- Maintain primary responsibility for CMC team meetings, including scheduling, preparation and communication of agendas and minutes, recording of decisions and action items; ensure team implementation of decisions and resolution on action items
- Enlist key stakeholders and SMEs to resolve obstacles to expedite drug development process through all phases
- Facilitate project conflict resolution and support escalation of critical project issues
- Create and manage CMC risk registers, and mitigation and contingency plans
- Lead CMC teams in preparation for Technical Operations governance reviews
- Maximize CMC team performance by optimizing collaboration, team dynamics, communication, and capabilities, and by identifying gaps and limitations and facilitating resolution with functional leadership
- Supports communication of CMC team strategy, plans, and progress to Asset team and to governance structure
- Support External Manufacturing Site Managers/teams for project related site start-up activities as required
- Serve as primary CMC project management contact for business alliances and ensure clear and effective communication across the alliance
- Support the CMC team in successfully transitioning through subsequent stages of product development
- Establish effective and accurate metrics to track team efficiency, and create and maintain dashboards to visualize project status and at-risk milestones
- Prepare monthly, quarterly, and other ad hoc presentations and status reports for Senior Management
- Conduct and document internal team reviews (e.g., risk or issue reviews, team evaluations, project post-mortems)
- Act independently to determine methods and procedures on special assignments
- Must possess exceptional organizational, communication, and planning skills
- Strong interpersonal skills and business acumen, excellence in building and managing relationships, ability to understand all perspectives, find common ground and effectively bridge significant differences
- Detail-oriented while also retaining the ability to see the big picture
- Demonstrated problem solving skills with strong business skills/acumen
- Proven ability to manage multiple projects, set priorities and meet deadlines
- Experience working on cross-functional teams to accomplish shared goals
- BS or BA in Science or Engineering required; an advanced degree or PMP certification preferred
- 8+ years of experience in pharmaceutical/biotechnology development area, including first-hand understanding of drug development process for oral dosage forms
- Strong experience in project management in global pharmaceutical drug development
- Deep understanding of clinical and commercial manufacturing, process development, analytical development and controls, technology transfer, validation, and CMC support of regulatory filings.
- Proven skills to independently manage and influence multiple project activities and plans simultaneously; direct management of at least one complex program
- Flexibility to support teams in multiple time zones
- Significant experience operating in a virtual business model
- Knowledge of ISO, Quality Systems and work in an FDA regulated industry
- Experience with planning, procurement, forecasting, logistics and customer service
- Strong proficiency with the use of Microsoft Project or Smartsheet, Excel, Word, and Power Point is required
- Strong analytical, interpersonal, leadership, and communications skills
- Proven ability to lead cross-functional project teams globally, to manage by influence and to work with diverse teams
- Expertise in decision analysis and conflict resolution
- This position may require approximately 10-25 percent travel, domestic and international
About Mirati Therapeutics
Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work family
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision - to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) - we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.