Job Opportunity

Sr. Manager, Clinical Outsourcing (Contract)

Location: NJ, US
Department: Integrative Sciences
Employment Type: Contractor
Reference Number: 2272786

Job Description Summary

Under the direction of the Director, the Sr. Manager, Clinical Outsourcing will lead and manage the clinical trial outsourcing, vendor selection and contract negotiation, vendor management, and reporting process for Mirati's clinical development programs. This role will be Instrumental in the management of external partnership outcomes for clinical trials, including coordination and management of service providers and other outsourcing needs.

Your Responsibilities

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.

Responsibilities:

30% Support Outsourcing Team

  • Locate Statement of Work (SOW) for each study level agreement; save the working documents as well as final contracts to the Clinical Outsourcing folder.
  • Ensure consistent naming convention
  • Review CRO Contract & populate category spend to allow for analysis
  • Ability to Liaise with project teams, CROs and Vendors
  • Ability to search Contract Management System
  • Create Vendor Contract Trackers for each study and update with contract data and terms
  • Collect and analyze data from CRO contracts
  • Setup Outsourcing Onboarding guidelines.
  • Support the development of templates and save to Outsourcing folders.
  • Setup cost-saving excel file.
  • 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

25% Vendor management: 15 - 25 Vendor per study

  • Participates in scheduling, organizing, and facilitating kickoff meetings with vendors.
  • Participates team meetings with vendors.
  • Supports the project teams to assure the quality and timeliness of deliverables through outsourcing.
  • Monitors and manages relationships with contracted vendors; facilitates the resolution of issues and conflicts.
  • Supports organizational governance activities with vendors.
  • Works with Project Teams to ensure outsourced clinical trial activities meet quality standards and expectations and adheres to applicable Corporate SOPs, WPs, policies, guidelines, and regulations.
  • Ensures smooth and effective communication between the vendors and the company.
  • Ensures Vendors/CROs are accountable and Identifies issues and develop solutions
  • Facilitates the closure of each study/contract with the vendor, including a mutual assessment of performance.

35% Vendor selection and contract negotiation:

  • Guides project teams through the outsourcing process and gives appropriate suggestions and advice on the best approach / best practices
  • Guides and participates in the evaluation, selection, and negotiation of contracts for assigned studies/programs.
  • Works with Project Managers and Project Teams to develop RFPs.
  • Works with Project Managers and Project Teams for all operational, scheduling, project budget and cost-saving considerations for assigned studies/programs.
  • Liaises with project teams to develop the Statement of Work (SOW) for each contract; coordinates the SOW review and finalization process.
  • Negotiates new and amended work specifications, budgets, payment schedules, relationship management plans, and other documents that control the activities and performance of contract service providers.

10% Cross-Functional Support

  • 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

  • Bachelor's degree with minimum 2 years of clinical outsourcing 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
  • Must have extensive experience managing CROs, central laboratories, and other clinical study vendors, including trial sites
  • 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
  • Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). Microsoft Project a plus.

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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on Twitter and LinkedIn. 

Why Join?

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.