Replimune is pioneering a new generation of cancer treatments called oncolytic immunotherapies. These cleverly designed therapeutics combine multiple mechanisms of action, enhancing the ability of viruses to replicate in and kill cancer cells, generating a powerful patient-specific, systemic immune response. We are continuing to grow our organization in both our Woburn, MA headquarters and our new, state of the art Manufacturing facility in Framingham, MA.
Summary of job description:
The Associate Director, Clinical Operations (AD, Clin Ops) 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 AD, Clin Ops manages the clinical project team to ensure adherence to overall project timelines and budget. The AD, Clin Ops is expected to provide leadership and a strategic direction within the department and expert guidance in the operational aspects of executing clinical development deliverables. The AD, Clin Ops manages people.
- Drive study execution, including management and oversight of CROs, vendors and consultants that are involved with the clinical trial and program.
- Responsible for oversight and project management of individual studies as well as relevant program related activities.
- 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
- Provides strategic input and leads investigator recruitment/selection across project/program.
- Ensure trial adherence to ICH-GCP, Federal and local regulations and company specific SOPs.
- Ensure study staff is appropriately trained on relevant guidelines, regulations and SOPs.
- Participate in program strategy meetings, ad hoc clinical operations’ initiatives and programs.
- Drive preparation and review of clinical documentation such as Investigator Brochures, clinical protocols, informed consents, annual updates to regulatory authorities, and trial status updates.
- Maintain 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 with Program Lead.
- Active participation with the development of the clinical components of regulatory submissions including, but not limited to safety, interim and final study reports.
- Active 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.
- Facilitate and drive the development of clinical trial agreements and other relevant documents in partnership with clinical outsourcing.
- Active participation with request, 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) with Program Lead.
- Work cross-functionally and drive clinical program timelines and goals to ensure they are met.
- 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.).
- Bachelor’s degree in health sciences or related field.
Experience and skill requirement:
- Minimum of 9+ years’ experience in clinical research with at least 7 years’ experience in Global study management. Clinical Monitoring preferred.
- Advanced Experience in management of CROs, vendors and consultants.
- Experience with managing or mentoring employees directly or indirectly.
- Documented training, knowledge and application of current FDA Regulations, ICH-GCP guidelines for clinical trials required.
- Expertise in developing trial plans including site monitoring, risk mitigation strategies, trial and project budgets, site selection and clinical supplies management.
- Proficient written and verbal communication skills.
- Expert at collaborating effectively with the study team, cross- functional team members, external partners (including investigator and site staff) using collaborative negotiation skills and ability to manage upwards.
- Therapeutic (oncology) or medical knowledge preferred.
- Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
- Position may require some travel up to 20%
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.