Sr Director, CMC Project Management
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1995773
Job Description Summary
The Senior Director, CMC Project Management will be responsible for the building and overseeing the CMC Project Management function. CMC Project Management manages and supports Technical Operations projects covering multiple functional areas, including, but not limited to, Chemical Process R&D, Product Development, Analytical Development and Control, Clinical and Commercial Manufacturing and Supply Chain, Regulatory CMC, QA and CMC Alliance Management. As a member of the Tech Ops leadership team, you will be called upon to build a world-class project management organization. This position reports to our SVP of Technical Operations and will manage staff and/or development programs.
This is a unique opportunity to help transition the organization through our evolution as a U.S.-based research and development organization to a global commercial-stage biotech with potential for multiple products launching beyond 2022.
- Establish a clear vision for CMC Project Management function and establish world-class operating competencies including selection and implementation of technology
- Develops functional policies and oversees and/or authorizes their implementation
- Directs and manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy. Develops team members to their full potential.
- Oversees the creation and execution of a clear, integrated development plan from candidate selection to regulatory approvals, launch and life-cycle management
- Identify project risks, develops mitigation plans and maintains project risk registers
- Negotiates and influences key internal stakeholders and creates a motivated, committed and engaged project teams
- Ensure functional leads have clearly defined project scopes, deliverables and timelines
- Promptly escalates barriers to project delivery, particularly related to resource shortfall, performance issues, process inefficiencies, or other environmental factors
- Collect, consolidate and analyze project plans and information across projects and reports progress toward corporate objectives
- Prepare scenario plans to support decision-making and budgeting process
- In conjunction with project team, develop a yearly strategic program and development plans and annual budgets
- Coordinate sub-team activities as required and act as a single point of accountability for the seamless execution of project deliverables and decisions; ensuring 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 program
- 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
- Strong oral and written communication skills with ability to communicate effectively at all levels and present complex and/or new ideas both internally and with external stakeholders
- 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
- 15+ years of experience in pharmaceutical/biotechnology development area, including first-hand understanding of drug development process
- A minimum 10 years of management/supervisory experience, and proven ability to work collaboratively and communicate effectively on a multi-disciplinary team.
- 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
- Ability to work in a fast-paced environment, as well as a proven track record of working effectively in diverse teams involving multi-functional disciplines.
- 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
- Significant experience operating in a virtual business model
- Knowledge of ISO, Quality Systems and work in an FDA regulated industry
- This position may require approximately 20-30 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.