Associate Director, CMC Project Management
Department: 215 - Program Management : Jill Smith
Employment Type: Full Time
Reference Number: 1573270
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based late-stage biotechnology company relentlessly focused on translating drug discovery and research into new treatments for patients by advancing and delivering novel therapeutics that target the genetic and immunologic drivers of cancer. Mirati is advancing a novel pipeline to treat large patient populations across multiple programs and tumor types, including two programs, adagrasib (MRTX849) and sitravatinib, in registration-enabling studies to treat non-small cell lung cancer (NSCLC).
Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule, potent and selective KRAS G12D inhibitor in preclinical development.
Sitravatinib is an investigational spectrum-selective inhibitor of receptor tyrosine kinases (RTK) designed to enhance immune responses through the inhibition of immunosuppressive signaling. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a Phase 3 trial of sitravatinib in combination with nivolumab in NSCLC.
The Company has initiated plans to prepare for the commercialization of adagrasib by establishing its commercial and medical affairs team. Mirati's ambition is to continue to recruit and a build a world-class, high-performing team with a shared passion and dedication for transforming the future of cancer treatment.
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?
In this position you will be working with top tier talent to lead technical operations activities for a key Mirati asset. This role has room for growth as your skills advance and the products move along the development continuum.
The Associate Director, 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.
Day to Day Duties:
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
- 8+ 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
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 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.