Overview:
Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease.
At Replimune, we live by our values:
United: We Collaborate for a Common Goal.
Audacious: We Are Bold and Innovative.
Dedicated: We Give Our Full Commitment.
Candid: We Are Honest With Each Other.
People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients.
Join us, as we reshape the future.
Job Summary:
The Senior Clinical Project Manager (Sr CPM) is responsible for the planning, implementation and conduct of large, global, complex clinical trials in Phase I-IV; or multiple smaller early-phase studies. The Sr CPM manages the clinical project team to ensure adherence to overall project timelines and budget. The Sr CPM is expected to demonstrate leadership within the department in the operational aspects of executing clinical development deliverables. The Sr CPM may manage people.
This position can be based either in our Woburn office or be a remote role.
- Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.
Responsibilities:
- Manage study execution, including management and oversight of CROs, vendors and consultants that are involved with the clinical trial.
- Responsible for oversight and project management of individual studies as assigned.
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
- Leads risk identification, management, and mitigation efforts and reporting progress to senior leadership.
- Leads investigator recruitment/selection across project.
- Ensure study staff is appropriately trained on relevant guidelines, regulations and SOPs.
- Ensure trial adherence to ICH-GCP, Federal and local regulations and company specific SOPs.
- Participate or lead clinical operations’ initiatives and programs.
- Contribute to or drive preparation and review of clinical documentation such as Investigator Brochures, clinical protocols, informed consents, annual updates to regulatory authorities, and trial status updates.
- Maintains primary responsibility for the content of and execution on all study-related operational plans, such as study operations manuals, vendor manuals, project management plans, communication plans, and quality plans.
- Responsible for evaluation and reporting on aggregate site metric/KPI data (as obtained from monitoring visit reports, data collection, etc.) as part of quality management review.
- Review the clinical components of regulatory submissions including, but not limited to safety, interim and final study reports.
- Participation in forecasting Investigational Medicinal Product and clinical trial supplies, interacting with appropriate functional areas as needed to resolve issues.
- Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews.
- Participate and respond to Quality Assurance audits and/or regulatory authority inspections.
- Responsible for ongoing study communication and escalation of study-related issues as required.
Other responsibilities:
- Facilitate the development of clinical trial agreements and other relevant documents in partnership with clinical outsourcing.
- Active participation in creation and review of scope of work and budgets; vendor performance management and issue resolution.
- Manage clinical trial budgets, providing ongoing financial reporting and projections to leadership/finance.
- Responsible for creation and management of project-level budget(s).
- Work cross-functionally and drive clinical program timelines and goals to ensure they are met.
- May participate in site visits, evaluating CROs/contract monitors through co-monitoring visits and/or site audits.
- Provide study-specific mentoring and line management for junior team members, as appropriate.
- Assume leadership role in operational improvement initiatives (e.g. SOP development, training, etc.).
Qualifications:
- Bachelor’s degree in health sciences or related field.
- Minimum of 7+ years’ experience in clinical research with at least 5 years’ experience in study management to include large, global study experience a must have. Clinical Monitoring preferred.
- Experience in management of CROs, vendors and consultants.
- Documented training, knowledge and application of current FDA Regulations, ICH-GCP guidelines for clinical trials required.
- Experience developing trial plans including site monitoring, risk mitigation strategies, trial budgets and project budgets, site selection and clinical supplies management.
- Proficient written and verbal communication skills.
- Collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
- Therapeutic (oncology) or medical knowledge preferred.
- Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
- Position may require some travel.
About Replimune:
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
We are an Equal Opportunity Employer.
