Director, Clinical Operations
Immunocore

Conshohocken, Pennsylvania

Posted in IT


This job has expired.

Job Info


About the CompanyImmunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners. Key ResponsibilitiesCoordinate 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 analyze 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


This job has expired.

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