Clinical Outsourcing Lead
Department: Clinical Operations
Employment Type: Full Time
Reference Number: 1830761
Job Description Summary
Instrumental role in the development and management of external partnership outcomes for clinical trials, including coordination and management of service providers and other outsourcing needs. Responsibilities include clinical CRO/vendor identification, RFI/RFP development and execution, vendor selection, contract negotiations, budget management and service provider performance metrics development and tracking.
- Develop and document best practices for identifying, benchmarking and contracting clinical vendors
- Generate Request for Information (RFIs), Request for Proposal (RFPs) and budget grids/trackers for clinical trials; Assist in bid defense and proposal review meetings
- Ensure successful study start-up by identifying key vendors, developing contracting timelines, and engaging business partners; Facilitate contract negotiation as appropriate
- Assess portfolio resource demand and shortfall/mitigations for current and potential future portfolio with key vendors, including development of a database for identifying and maintaining current and potential service providers
- Responsible for negotiation and execution of the vendor contracts in collaboration with legal
- Responsible for contract lifecycle management in collaboration with legal
- Negotiate final scopes of work, budget, and payment schedules with input from cross-functional stakeholders for clinical study service providers
- Negotiate change orders and ensure service providers adhere to contract terms
- Review invoices against vendor contracts to ensure accuracy and service completion in partnership with Clinical Operations
- Ensure strategic vendor relationships are running efficiently and productively
- Actively manage clinical contractual obligations and support oversight of clinical trial execution with external partners
- Coordinate Joint Operations Committees and Executive Steering Committees with CROs on behalf of Mirati (including agendas, minutes, follow-up on action items)
- Develop KPIs and vendor performance scorecards to ensure the highest quality of outsourced delivery of Clinical Programs, on time and within budget
- Ensure appropriate governance documentation of partnerships is developed and maintained
- Address areas of concern and providing recommendations to mitigate against poor performance
- Act as vendor management lead for relationships with CROs
- Support integration of Mirati and CRO teams and process to facilitate success of new collaborations
- Assist with creating clinical trial budgeting models and what-if scenarios for future trials
- Assist with FP&A needs related to clinical vendors, including annual budgeting, periodic forecasting, and monthly budget vs. actual analysis
What is Required
- Graduate degree in a life science, finance or business strategy discipline
- Minimum of 10 years professional biopharmaceutical and or business organization experience
- Demonstrated expertise in forecasting, budgeting, data analytics, modeling, and process improvement design.
- Pharmaceutical portfolio experience across teams, collaborating with Clinical Operations, Cost Management, Finance and Procurement functions
- Vendor and or clinical CRO oversight experience, ensuring execution within budget, on time, and of the highest quality
- Positive management style, combined with superior communication skills and unwavering ethics and integrity
- Strong interpersonal skills with demonstrated ability to connect, collaborate and build relationships across all levels and functions and establish credibility with leaders and key external stakeholders
- 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
- Extensive knowledge of GCP and ICH principles of clinical trial conduct
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.