Job description

Director, Clinical Operations

91 Park Drive, Milton Park, Oxfordshire, OX14 4RY, UK

DIRECTOR, CLINICAL OPERATIONS

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

The Role:

  • Support and coordinate specific clinical development activities related to assigned study or program.
  • Provide clinical development expertise and input at various cross-functional teams supporting the development of assigned study or program.
  • Accountable to lead clinical strategy and coordinate execution of all clinical development activities specific to assigned study or program.

Responsibilities:

  • 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 analyse and interpret data, identify trends and signals, and prepare succinct data summaries for review by Study Physician in preparation for Dose Escalation meetings with Investigators.
  • 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.
  • Take the lead in drafting all 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.
  • Provide support/escalation point for more junior Clinical Scientists as applicable.
  • Interact directly with investigators and other key site staff and be able to handle a broad range of issues including (but not limited to) overall site performance, study conduct and compliance, scientific engagement, and investigator relationships.
  • Provide leadership and guide decision making within the Clinical Study Team.
  • 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).
  • May be asked to step up and lead strategy and execution for development of one or more infectious diseases ImmTAV programs serving as the Program Lead-see Job Description for Program Lead for ImmTAV program(s) for additional details.
    • Single point of accountability for ImmTAV program(s) leading cross functional matrix team to ensure timelines, budget goals and clear objectives.
    • Integrate recommendations from all functions to ensure rapid and clear decisions made and issues escalated.
    • Represent program to senior management and externally.

Qualifications: 

Essential

  • 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.
  • Ability and willingness to represent clinical development voice at cross-functional team meetings.
  • Ability to integrate complex clinical and translational data.
  • Demonstrated ability to lead clinical teams.
  • Ability to listen to and integrate input from cross-functional team and then make clear decisions.
  • Experience leading interactions with global health authorities in support of IND/First in Human stage programs.
  • Strong interpersonal skills with the ability to drive and influence decision-making.
  • Professional exposure to multiple functions within biopharmaceutical drug development.
  • Ability to work closely and collaboratively with senior leaders from across the company.

Desirable

  • Deep understanding of, and experience with, developing therapies in infectious diseases, especially HBV and HIV.
  • Experience working with CROs including providing oversight.
  • Previous experience managing direct reports.
  • Experience leading interactions with global health authorities in support of BLA/labelling.

Other 

  • 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.

Education:

  • PhD, Pharm D, MS or BS in a related scientific subject
  • Experience in infectious diseases drug development
  • 8+ years of pharmaceutical industry experience with at least 3 years of clinical development experience

Lead with Science and Discover What is Within:

  • We Value Entrepreneurship and Diversity
  • Respect, Trust, and Integrity
  • Competitive compensation
  • Private medical and dental benefits.
  • 25 days Annual Leave and Bank Holidays
  • 4x Salary Life Insurance
  • 5% Pension Match
  • Income Protection
  • Parental Leave

  

 

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