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Senior Clinical Scientist

Conshohocken, Pennsylvania, United States

Senior Clinical Scientist
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.

Our next area of focus is Infectious Diseases (ID) where we are evaluating the potential of our TCR bispecific platform to achieve a “functional cure” in people with chronic HBV and HIV infections who are well controlled on antiviral therapies.  This role will lead and coordinate a variety of clinical development activities related to assigned ID studies, building on published preclinical data in HBV and HIV, and provide clinical development expertise and input to various cross-functional teams. To learn more, go to:

  1. https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31503
  2. https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(16)45448-1?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1525001616454481%3Fshowall%3Dtrue

This position is located in Conshohocken, PA or Rockville, MD.

 

Key Responsibilities

  • Ensure adherence to pertinent regulatory requirements (e.g., GCP) and to departmental policies, practices and procedures.
  • 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 timelines

 

Experience & knowledge

Essential

  • Deep understanding of, and experience with, developing new therapies in HBV and/or HIV
  • Background in immunology and experience with immunotherapeutics
  • 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
  • Excellent communication skills, with proven ability to write clear, accurate, concise scientific / clinical documents
  • Ability to think outside the box and problem-solve
  • Experience working with CROs including providing oversight

 

Education

  • PhD, Pharm D, or MS in a related scientific subject
  • Experience in infectious disease drug development

 

Other

  • Periodic travel (~15-20%) to participating study sites, scientific conferences, and Immunocore sites will be required (includes overnight and international travel)

 

Lead with Science and Discover What is Within:

  • We value Entrepreneurship and Diversity
  • Respect, Trust, and Integrity
  • Competitive compensation
  • Medical and vision benefits, beginning your first day of employment
  • Fully paid Dental Insurance
  • 20 days’ vacation plus holidays
  • Fully paid Life Insurance and Disability
  • 401(k) with Company Match

 

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.

Immunocore is an E-Verify employer.   

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