Sr. Clinical Compliance Manager
Location: Conshohocken, PA or Rockville, MD
Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. We are developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs.
It is an exciting time to join Immunocore. Our most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies. The company also recently completed its Initial Public Offering and was listed on the NASDAQ.
The Sr. Clinical Compliance Manger is responsible for the management and execution of clinical activities associated with Good Clinical Practice (GCP) activities including clinical procedural development and maintenance, clinical training programs, inspection preparedness, and assessment and investigation of clinical quality compliance issues. This position may also support management and execution of clinical vendor qualification assessments working in collaboration with quality assurance.
- Provide support and assistance to the Clinical Developments team to ensure delivery of the portfolio according to Good Clinical Practice.
- Manage and oversee development and approval of controlled documents related to clinical study processes and systems including Policies, SOPs, Work Instructions, forms and templates in compliance with global regulatory standards
- Execute strategy for role-based curriculum and GCP training within the Clinical organization
- Develop and Deliver CGP and Inspection Readiness training for the Clinical organization
- Ability to work with functional teams to flow out processes and develop previously unwritten work instructions and/or development of New SOPs
- Assist and collaborate with QA with the preparation/collection of all training documents in preparation for internal training file audit (e.g. completed SOP matrices, CVs, JDs etc.)
- Oversee and/or conduct functional assessments including but not limited to vendor/contractor qualification assessments in collaboration with Quality Assurance
- Manage, oversee the tracking and trending of Suspected Serious Clinical Non-Compliance Issues (SSCNCI), including reporting (if applicable) and ensure follow-up and closure
- Support the completion of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities.
- Execute plans with clinical teams and cross-functionally to prepare for audits and regulatory agency inspections
- Provide representation and support for Clinical Development in Sponsor audits and Regulatory Agency inspections. Supervise Clinical preparation room activities
- Manage follow-up within Development organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)
- Supports and prepares internal and external clinical teams for audits (both internally and by regulatory agencies)
- Directs and trains on Clinical Standard Operating Procedures and Clinical Operating Procedures to ensure compliance with regulatory organizations.
- Organizes pre- and post-study document reviews and takes corrective action.
- Provides leadership in continuous improvement of good clinical practices.
- Monitors audit reports to clinical management.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function.
- Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
Experience & knowledge
- At least 10-15 years relevant experience in a biotechnology/pharmaceutical industry and/or clinical research organization with at least 10 years’ experience in compliance, quality, training or related clinical operations function.
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP
- Experience in global privacy requirements including but not limited to GDPR and country specific privacy regulations
- Ensure an enthusiastic and open attitude towards continuous professional development
- Experience with the following skill set:
- Performing PAI and Inspection readiness assessments
- Presenting high level presentations, both orally and in writing using organizational skills to complement this
- Delivering open and honest constructive (positive and/or negative) feedback pertaining to work in hand
- Taking responsibility and ownership for entrusted tasks; seeing tasks through to completion and dealing with the consequences of failure or success.
- Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities. Handling disjointed tasks effectively. in a highly collaborative, multi-disciplinary team setting.
- Being able to work productively with others to achieve tasks while showing consideration for the needs and feelings of others.
- Accomplishing goals under project timelines.
Education & qualifications
- BA / BS or higher in science related field (biological science, medical, pharmacy or other health related discipline)
- 10-15 + years’ relevant experience in biotechnology/pharmaceutical industry and/or clinical research organization specifically focused in the following areas: compliance, quality, and GCP training
- Clinical Operations functional background
- Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint)
Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.