Job Description Summary
The Senior Manager, CMC Project Management will manage and support Technical Operations projects covering multiple functional areas, including, but not limited to, Clinical and Commercial Manufacturing, Process Development, Analytical Development and Control, Technology Transfer, Validation, CMC Support of Regulatory Filings, and CMC Alliance Management.
- Support the implementation of assigned Technical Operations projects from initiation to implementation
- Prepare and maintain overall project timeline and provide appropriate benchmarking and risk management information
- Ensure functional leads have clearly defined project scopes, deliverables and timelines
- Work with functional leads to ensure that project priorities are clearly documented
- Follow up on issues, actions and risks to program
- Apply objective and rational, critical thinking and seek to identify contingency and mitigation plans and enlists key people to resolve obstacles to expedite drug development process through all phases
- Collect, consolidate and analyze project plans and information across projects
- Prepare development scenario plans to support decision-making and budgeting process
- Develop, in conjunction with project team, yearly strategic program and development plans and annual budgets
- Support overall team function and team leaders in their strategic function
- Coordinate sub-team activities as required and act as the central core of project team information; ensure activity owners are completing assigned project tasks
- Maintain primary responsibility for project team meetings, including scheduling, preparation of agendas and minutes, and action items
- Serve as primary CMC project management contact for business alliances and ensure clear and effective communication across the alliance
- Develop effective and accurate project metrics reporting criteria and standards
- Prepare monthly, quarterly and other ad hoc presentations and status reports for Senior Management
- Conduct reviews (e.g., risk or issue reviews, team evaluations, project post-mortems)
- Act independently to determine methods and procedures on special assignments
What is Required
- Must possess exceptional organizational and communication 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
- 7+ years of experience in pharmaceutical/biotechnology development area, including first-hand understanding of drug development process
- Solid understanding of clinical manufacturing, process development, analytical development and control, technology transfer, validation, and CMC support of regulatory filings.
- Experience in project management in global pharmaceutical drug development
- Proven skills to independently manage and influence multiple project activities and plans simultaneously; direct management of at least one complex program
- 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
- Proficiency / experience with the use of Microsoft Project, 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 10-20 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 KRAS G12C 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 KRAS G12D 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.