Immunocore (Location: Conshohocken, PA, Rockville, MD or Abingdon, UK)
Immunocore is an innovative and dynamic biotechnology company developing a unique platform of T cell receptor (TCR)-based therapeutics, called ImmTAXs, as a novel class of treatments for cancer, infectious and autoimmune diseases.
Immunocore has a well-established pipeline of wholly owned programmes, of world leading science and strong IP position, which has led to discovery collaborations with Genentech, GlaxoSmithKline, Medimmune as well as a co-discovery & co-development partnership with Lilly, and recent investment from the Bill & Melinda Gates Foundation.
As clinical validation of our platform, we recently announced positive results from our Phase 3 clinical trial of tebentafusp (off-the-shelf, soluble, bi-specific TCR targeting gp100) vs. Investigator Choice (pembrolizumab, ipilimumab, or dacarbazine) in first-line metastatic uveal melanoma (mUM) where the overall survival (OS) hazard ratio in the intent-to-treat population favored tebentafusp (HR=0.51; 95%CI:0.36, 0.71, p<0.0001). This represents the 1st positive Phase 3 clinical trial for any TCR therapeutic, first for any bispecific in a solid tumor, and the first new therapy to improve OS in patients with mUM in 40 years.
The main purpose of the role is to support and coordinate specific clinical development activities related to assigned study or program (for oncology and/or infectious disease indications) and provide clinical development expertise and input at various cross-functional teams supporting the development of assigned study or program.
- Ensure adherence to pertinent regulatory requirements (e.g., GCP) and to departmental policies, practices and procedures.
- Must ensure knowledge is kept up to date by reading/training on relevant SOP’s assigned to role
- Maintaining knowledge and awareness of GCP guidelines by maintaining GCP certification provided by Immunocore
- Ensure all work performed on assigned study(ies) or program(s) meets all GCP/ICH Guidelines and is Inspection Ready
- Routinely review study data on an ongoing basis on all assigned study(ies) to ensure consistency and validity from a clinical perspective
- This includes (but is not limited to) reviewing primary and secondary safety, pharmacokinetic, pharmacodynamic, and efficacy endpoints for consistency, potential signals (of interest or concern), and trends
- This also requires working in concert with data management and clinical operations to resolve data discrepancies (e.g., in-stream data review, coding review)
- This includes regular review of protocol deviations for appropriate classification, corrective action, and escalation (if need).
- Able to draft content for abstracts and posters based on data from assigned clinical studies
- Contribute to drafting of protocol synopses, protocols, protocol amendments, and clinical study reports
- Review and provide clinical development input on relevant sections of all other key study documents [e.g., informed consent form (ICF), Case Report Forms (CRF), Laboratory and Pharmacy Manuals, Investigator’s Brochure (IB), Development Safety Update Report (DSUR), Investigational New Drug (IND) application/Clinical Trial Application (CTA) ]
- Review and provide input on the design of CRFs from a clinical perspective; participate in user acceptance testing to ensure the appropriate support of data collection
- Support site selection and site activation activities including contacting investigators to discuss potential interest in assigned study, developing slides for site initiation visits (SIV), and performing SIVs as needed
- Identify and communicate study issues that will impact budget, resources and timeline
- Provide expert and collegiate support to other members of the drug development team to ensure full success of the company’s portfolio and regulatory milestones
- Contribute to the department- or company-related process improvement initiatives (e.g., review/contribute to development or revision of SOP or Work Instruction)
Experience & Knowledge
- Understand and apply the principles of GCP
- Thorough understanding of the drug development process including experience with contributing to the development of key clinical documents (e.g., protocols, ICF, IB, DSUR, CRF) and ability to review clinical data for consistency and coherence.
- Experience must include early phase clinical studies
- Must demonstrate clear understanding of how to safeguard patient safety during the conduct of clinical studies
- Review and provide input into Serious Adverse Event reports
- Review lab data and adverse events looking for trends
- Contribute to the design of clinical protocols that incorporate appropriate monitoring and risk mitigation for study subjects
- Strong understanding of how translational medicine supports the drug development process
- Must understand how to incorporate biomarkers into early phase studies
- Experience must include how to analyse and interpret biomarker data from early phase studies
- Ability to work effectively in cross-functional teams
- Self-motivated; demonstrated success in delivering assigned tasks according to timelines
- Ability to think outside the box and problem-solve
- Deep understanding of, and experience with, developing immunotherapy in oncology
- Experience conducting early phase clinical trials in infectious disease setting
- Experience working with CROs including providing oversight
Education & Qualification:
- 3+ years of pharmaceutical industry experience
- Periodic travel (~15-20%) to participating study sites as well as between Immunocore US sites will be required (includes overnight and international travel)
- Attendance of leading industry meetings as required
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.