Job description

Executive Director, Kimmtrak Clinical Program Lead

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

EXECUTIVE DIRECTOR, KIMMTRAK  CLINICAL PROGRAM LEAD  

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:

The Executive Director, Kimmtrak Clinical Program Lead will be accountable to develop and execute the Life-Cycle Management (LCM) strategy and to provide medical oversight for the Kimmtrak program.

This will require: 1) working cross-functionally to identify existing data gaps in the uveal and cutaneous melanoma settings; 2) developing a rigorous data generation plan to address the identified gaps; 3) developing  timely Requests For Proposals (RFPs) based on an aligned Externally Sponsored Research (ESR) Strategy and internal planning cycles, shepherding ESR proposals through governance, and ensuring ESR studies are executed to agreed upon timelines and budget; 4) serving as the point of escalation for any safety issues identified in the global Expanded Access Program as well as from ongoing ESR trials 5) designing and executing sponsored clinical studies in support of the LCM strategy; 6) serving as the single point of accountability for ensuring the safety of all study participants and compliance with sponsored study protocols; and 7) supporting the Kimmtrak publication plan and ensuring it is aligned with the LCM strategy. 

To be successful, the Executive Director, Kimmtrak Clinical Program Lead will need to work with stakeholders across the Immunocore organization, including (but not limited to) the Kimmtrak Global Product Team, Medical Affairs, Commercial, Regulatory, Translational Medicine, and Research functions.

Responsibilities:

  • Accountable for analysing and interpreting clinical and translational data emerging from across the Kimmtrak program with a goal to identify trends and signals in safety, translational, and efficacy data and to translate this information into an LCM strategy with the highest probability of success and that improves our understanding of the ImmTAX platform and underpins the Publication plans.
  • 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.
  • Serve as the Medical Monitor on clinical trials within their assigned program (as well as for one or more clinical trials outside their assigned program, as needed) ensuring the safety of study participants, adherence to the study protocol, scientific rigor, and compliance with all applicable Health Authority regulations as well as design and implement safety monitoring plans for such clinical trials.
  • Routinely review sponsored study data, pharmacovigilance data (including spontaneous safety reports), MSL insights from the field on an ongoing basis to ensure that any new information regarding safety or efficacy is appropriately incorporated into the LCM strategy.
    • 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 will include integrating all emerging safety information into a data generation plan as well as assessing, in collaboration with Pharmacovigilance, whether any emergent safety signals and trends are present, including the need.
      • for any potential changes to Health Authority approved prescribing information or training material for healthcare providers, and to communicate this information to the Global Product Team and senior management.
      • to update sponsored and ESR trials, patient Informed Consent Forms, Investigator Brochures, and other related clinical documents and to communicate this information to the relevant Clinical Development teams and the Global Product Team.
    • 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).
  • Work in close collaboration with Field Medical team, Medical Information and US/EU Medical Leads to analyse and integrate insights into the LCM plan, including development of action plans and data generation plan for high priority insights.
  • Analyse and interpret data, identify trends and signals, and synthesize key learnings to impact the LCM plan as well as to shape the translational medicine plans so they are complementary to the clinical development plans.
  • Work with the Global Product team in developing a publication plan and support the drafting of content for abstracts and posters based on trial data from sponsored clinical trials ensuring a scientifically rigorous, coherent, and consistent approach to publications that is aligned with the LCM strategy.
  • Lead and oversee the drafting of protocol synopses, protocols, protocol amendments, and clinical study reports.
  • Provide clinical development input on relevant sections of 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 as well as Contributing to the development of patient recruitment and retention strategies.
  • Identify and communicate study issues that will impact budget, resources, and timelines.
  • Provide support/serve as the single point of escalation for Clinical Development team(s).
  • 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, clinical queries from study sites, scientific engagement, and investigator relationships.
  • Cultivate relationships with global thought leaders, investigators, and cooperative groups with a primary focus on melanoma, while gathering input on data gaps and potential future LCM and ESR opportunities; also needs to determine appropriate prioritization and determination whether proposals should be sponsored, ESR, or collaborations with cooperative groups.
  • Work with Medical Affairs to develop an advisory board plan and work with Clinical and Medical to optimally utilize standing advisory councils (including participation in meetings and development of agendas) in support of the LCM strategy as well as the ESR strategy.
  • Provide leadership and guide decision making within relevant Clinical Study Team(s).
  • In collaboration with the cross-functional team members, take accountability for generating appropriate responses to study-related questions from Institutional Review Board/Ethic Committee and Health Authority.
  • Provides clinical support to medical affairs and commercial colleagues by providing relevant information about ongoing clinical programs (including emerging safety and efficacy signals) and top-line study results.
  • Executes and/or deliver trial specific and/or therapeutic training as required.
  • Maintain knowledge of trends and changes of importance in the medical management of indications relevant to company projects.

 

Qualifications: 

Essential

  • Working knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus.
  • 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 with specific emphasis on the following:
    • Strong understanding of clinical medicine, disease processes, and patient management relevant to the therapeutic areas of interest to Immunocore and in the context of clinical trial management.
    • Ability to 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.
    • Experience incorporating a diagnostic into late phase programs is a plus.
  • Experience creating and maintaining healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required.
  • Ability to work effectively in a matrixed environment with relevant teams such as clinical operations, statistics, regulatory, pharmacovigilance and translational medicine.
  • Excellent written and oral communication including presentation skills and experience delivering effective presentations on both technical and nontechnical subjects.
  • Ability to coordinate clinical study team meetings with other internal cross-functional team members, clinical investigators and vendors, as required.
  • 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 (required) and in support of BLA/NDA/MAA (highly desirable).
  • 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.

Education:

  • Medical Degree (M.D., DO or equivalent) with experience prescribing medicines in a patient care setting.
  • Possesses the ability to critically evaluate medical/scientific information.
  • At least 5 years of relevant experience in clinical development with at least some late-stage experience in pharmaceutical industry and/or academia.
  • At least 3 years of experience as a medical monitor in a biotechnology/ pharmaceutical company, and/or CRO.
  • Understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements.

Desirable

  • Training and experience working in Immunotherapy, Oncology and/or Infectious Diseases is preferred.
  • Documented work experience/knowledge of statistics.
  • Demonstrated computer skills; proven functional knowledge of Microsoft packages and ability to develop proficiency in relevant Immunocore software systems and programs.

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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