Company Overview: Developing cellular immunotherapies for severe life threatening infections. ViraCyte’s current products restore natural immunity against life threatening viruses in patients with severely weakened immune systems, such as adults and children who have recently undergone a hematopoietic stem cell transplant (HSCT). ViraCyte’s lead T cell products are in Phase 1 and Phase 2 clinical trials, with effectiveness rates of greater than 90% in patients who have failed conventional therapy. ViraCyte is planning randomized Phase II and Phase III clinical trials, which are poised to initiate patient enrollment within 6 months.
Position Summary: The Sr. Director, Clinical Operations oversees all facets of the Company’s clinical operations and is responsible for the successful execution and management of the Company’s clinical trial(s), responsible for resourcing, development, training and management of the clinical operations team, overseeing operational implementation of a clinical development plan, creating and managing timelines, negotiating budgets for clinical activities, and supervision of clinical trial CRO(s).
Key Essential Functions:
- Provides day to day management of clinical programs.
- Participates in the selection of clinical trial related CROs.
- Evaluates and recommends external resources.
- Manages relationship with CROs and clinical sites.
- Supervises study managers and other clinical support staff.
- Negotiates and manages budgets for clinical activities.
- Works closely with medical staff to assure current medical standards are embedded in clinical studies.
- Responsible for compliance of ICH GCP guidelines and related SOPs.
- Provides program management for all clinical and related disciplines.
- Monitors and ensures pharmacovigilance activities are run according to the clinical protocol and safety plan.
- Oversees data management, statistics and report preparation (includes synopsis, protocols, ICF, CRF).
- Manages drug supplies.
- Manages updates to Investigational Brochure and clinical protocol amendments.
- Participates in the review of the regulatory submission filings.
- Work closely with the CMO, Project Leader and other team members to best integrate clinical activities in the global project plan.
- Present clinical activities and progress to the Project Team.
- Host meetings with potential new vendors, to assess capabilities and establish good relationships.
- Maintain and develop expertise in clinical trial conduct and related regulation.
- All other duties as assigned.
Required Skills & Abilities:
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form;
- Ability to analyze and summarize data;
- Effective written and verbal communication skills (fluent in the English language, both oral and
- Excellent editing and documentation skills;
- Excellent problem solving skills;
- Strong organizational skills;
- Detail oriented and accurate;
- Strong working knowledge of MS Office products, specifically Microsoft Project;
- Ability to multi-task and prioritize work assignments with little supervision; and
- Ability to work productively with team members and work independently.
- Bachelor Degree in a medical/health/science related field;
- A minimum of 5 years of experience, with expertise in areas of clinical operations development, strategic planning, developing, implementing, and leading early to late stage clinical trials;
- Experience in hematology/oncology/biologics;
- Strong knowledge of ICH/GCP, guidelines, quality standard and regulatory requirements; and
- Leadership skills (i.e., managing outside collaborators and investigator sites)
- Core qualifications above;
- Direct experience with allogeneic stem cell transplantation/infectious diseases;
- Experience with global drug development, FDA/EMA, and IND and NDA/BLA filings;
- Experience developing Clinical Study Reports, INDs, SOPs and other clinical, regulatory and safety documents.
Interested candidates should submit/email ViraCyte at firstname.lastname@example.org