Houston, TX/Brisbane, CA/Remote
About this job
Bellicum Pharmaceuticals is a clinical stage pharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including both hematological and solid tumors, as well as orphan inherited blood disorders. We are dedicated to creating an exceptional work environment where we develop products that can make a difference in the quality of life for patients.
Bellicum has a great opportunity for a Clinical Program Manager/Senior Clinical Program Manager – Oncology/Hematology who will provide project management oversight and leadership of all clinical trial team activities for their respective program and report to the Executive Director of Clinical Operations. The CPM is responsible for achieving successful delivery of Bellicum clinical trials by meeting company and regulatory requirements according to time, quality, scope and budget constraints. This position may be based in Houston, San Francisco or Remote.
Specific Job Duties
- Proactively manage all operational aspects of the clinical trials within their assigned program including but not limited to management of trial timeline, budget, resources and vendors.
- Senior CPM: Provide functional supervision to Clinical Operations staff as assigned. Develop measurable objectives, identify training needs to foster high performance, support career development plans, proactively manage performance issues and establish key performance indicators in alignment with department and company objectives.
- Represent Clinical Operations at cross-functional Project Team meetings and present department updates including status of trial-level activities, program initiatives, etc.
- Coordinate trial activities across all Bellicum relevant business units, vendors, sites and CROs; build and maintain effective working relationships with interfacing groups.
- Ensure effective project plans are in place and operational for each trial and work proactively with the clinical trial team members (both internal and external) to set priorities in accordance with applicable company standard operational procedures, policies, ICH/GCP guidelines and regulatory requirements.
- Ensure study risks are appropriately escalated to the Executive Director of Clinical Operations.
- Chair and lead clinical trial team meetings and ensure meeting minutes are completed, distributed to team members and filed in a timely manner.
- Monitor the quality of vendor deliverables, address quality issues and identify opportunities to improve training, execution and data flow across all trials within assigned program.
- Review and approve vendor invoices in collaboration with Accounting team to ensure payments are issued in a timely manner
- Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements.
- Foster and cultivate relationships with key opinion leaders and other experts in the healthcare community.
Skills, Minimum Education, and Experience
- BS in the life sciences or related discipline, at minimum
- 10 or more years of clinical operations experience, with increasing levels of responsibility, in the Pharmaceutical, Biotechnology industries and at least 5 years of current clinical project management experience at a sponsor and/or CRO
- Therapeutic experience in oncology, cellular/transplant therapy
- Experience in early phase trials (Phase I-II) and First-In-Man studies
- Additional requirements include strong project management skills and communication skills. Ability to work both independently and as part of a team demonstrating excellent communication and interpersonal skills is required. Knowledge of GCP and FDA drug/biologics regulations.
We offer a competitive Total Rewards program including stock options, relocation support if required and employer supported benefit premiums. We thank you for your interest in Bellicum but please be advised that only those candidates selected to move forward will be contacted.