Director, CMC Project Manager: 2020-63
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology company dedicated to advancing novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer. Mirati is developing sitravatinib, designed to selectively target a spectrum of tyrosine kinases implicated in both tumor growth and the suppression of immune responses to tumors. Sitravatinib has demonstrated durable responses in lung cancer patients whose cancer has progressed despite treatment with checkpoint inhibitors - an area of significant unmet medical need. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC) that is currently enrolling patients.
Mirati is also developing novel direct inhibitors of KRAS mutations including MRTX849, a potent and selective inhibitor of KRAS G12C. This historically difficult to drug target is present in approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer as well as smaller percentages of several other difficult-to-treat cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial as a treatment for patients with KRAS G12C-positive tumors. Our research on G12C has led to breakthroughs in targeting other KRAS mutations including G12D which drives tumor growth in more patients than G12C and includes pancreatic, colorectal and other types of cancer.
We are Mirati
Our mission is to discover, design, and deliver breakthrough therapies to transform the lives of cancer patients and their loved ones. We have built a culture fueled by accountability, urgency, collaboration and open-mindedness, and have established ourselves as an innovator within our industry. As we grow, we are looking to build diverse teams, with skilled individuals that are passionate about their work.
Why join us?
The Director, CMC Project Manager 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. This position may manage staff and/or development programs.
- 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
- 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
What is Required:
- BS or BA in Science or Engineering required; an advanced degree or PMP certification preferred
- Ten plus years of pharmaceutical/biotechnology development area, including first-hand understanding of drug development process
- Solid understanding of clinical and commercial 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
Mirati's policy is to provide equal employment opportunities to all applicants and employees without regards 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 informations, 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.