Manager, Clinical Outsourcing
Department: Clinical Development Operations
Reports to: Chief Medical Officer
Location: Woburn Office – US
Summary of Job Description:
The Manager, of Clinical Outsourcing will play a critical role as part of Replimune’s Clinical Development team. This individual will develop and manage the operational and strategic processes, which support the implementation and management of global clinical outsourcing.
They will lead and manage activities related to the outsourcing of clinical services including; coordinating the service provider identification and selection processes, requests for proposal and bid defenses, negotiating work/change orders, and maintaining contracts for Clinical Research Organizations (CROs) and functional service providers for the Clinical team.
They will serve as a bridge between clinical teams and external service providers. They will also participate in continuous improvement initiatives, which quicken or provide efficiencies.
- Drive outsourcing activities by interfacing with functional departments and service providers for successful selection, contracting and execution of trials while ensuring compliance with regulatory standards, ethical practices and Replimune policies and procedures.
- Manage the identification, selection and evaluation process of service providers in collaboration with the trial management teams.
- Manage the process of Request for Proposals (RFPs) development from service provider selection through final contract execution, including facilitating the proposal review with the trial management team and assist the team in the decision-making process.
- Manage the contracting activities including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments.
- Negotiate services descriptions, scope of work, budgets and payment schedules using costing tools as necessary, with input from the trial management team.
- Facilitate trial kickoff/familiarization meetings to clarify timelines, roles and responsibilities, and budgets.
- Support trial management teams in the resolution of service-provider performance issues and manage service provider relationships ensuring issue resolution and efficient outcomes, as applicable.
- Facilitate or attend lessoned learned meeting as necessary to incorporate improvements in new projects.
- Monitor outsourcing environment to keep current on providers and industry trends.
- Collaborate effectively with all relevant functional departments (e.g. Finance, Legal etc.) to ensure appropriate review and approval of clinical vendor contracts.
- Identify best practices; lead the development and implementation of new processes.
- Participate in other ad hoc projects as needed
- Degree in Legal, Life science, Business Administration or equivalent. Advanced degree a plus.
Experience and Skill Requirement:
- At least 4 years direct experience in managing clinical vendor contracts within the pharmaceutical industry within a clinical procurement/outsourcing function to include experience in the negotiation of contracts with Phase I-IV CROs, technical service providers, consultants, etc. Scientific, Financial and Project Management experience desired
- Proven experience in developing relationships with key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into processes as appropriate
- Team player able to form strong cross-functional relationships, demonstrating an ability to influence/persuade others.
- Experience working with all levels of management and consulting with key business stakeholder with an ability to influence for greater outcomes
- Proven time management skills and ability to be flexible to meet job demands and be proactive and take on new initiatives and improvement efforts
- Ability to sustain high levels of performance in a constantly changing environment.
- Demonstrates business/financial acumen and thorough understanding of CRO/Vendor cost models and budget as well as services and costs associated with functional service providers (e.g. IVR, Central Labs, Imaging, Data Management).
- Must have excellent written and oral communication skills, as well as high level of proficiency with conflict resolution and negotiation.
- Excellent analytical and problem-solving skills.
- Highly organized with strong negotiation skills and eye for detail.
- Must have good leadership and project management skills.
- Thorough knowledge of GCP/ICH Guideline and Regulations and clear understanding of the drug development process.
- Proficiency in MS Office Suite.
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition.
Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.