Associate Director, Clinical Scientist
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 ResponsibilitiesASSOCIATE DIRECTOR, CLINICAL SCIENTIST

The Role:

Execute clinical development activities including analysis, interpretation, and presentation of data for one or more assigned studies.
Provide clinical development expertise and input to clinical study team and ad-hoc support for program team.
Contribute to development of the clinical strategy.
Mentor junior clinical development scientists.

Responsibilities:

Ensure adherence to pertinent regulatory requirements (eg, ICH GCP) and Immunocore policies, practices, and procedures.
Collaborate with Regulatory and Compliance to foster a compliant, high-quality, and inspection ready culture, adapt to changes in regulatory requirements, and improve SOPs and work instructions.
Perform routine data reviews (including safety, efficacy, and biomarkers), write queries, and escalate issues in collaboration with Data Management and Clinical Operations.
Analyse and interpret safety, efficacy, and PK/PD data and identify trends and signals in collaboration with Biometrics, Translational Medicine, and Pharmacovigilance teams.
Present study results to study team, Investigators, and governance bodies.
Draft content for abstracts, presentations, and posters.
Lead authoring of selected clinical documents (eg, Protocol, Investigator's Brochure, Informed Consent) and participate in review of all key study documents.
Provide clinical input on training slides, study plans / manuals, and CRF design.
Support site selection, activation, and engagement activities including outreach to Investigators and performing trainings at site initiation visits.
Foster cross-functional collaboration and develop potential solutions to study issues that may impact budget, resources, and/or timelines.
Provide expert, collegial support and leadership to achieve study and program objectives.
Identify opportunities and lead process development initiatives.
Establish best practices and ensure a consistent approach across studies and teams.

Qualifications:

Essential

Understand and apply the principles of GCP.
Deep understanding and extensive experience in the processes and strategy of drug development, with a focus on first-in-human / early-stage oncology.
Excellent data analysis, data visualization, and communication skills, with proven ability to write clear, accurate, and concise documents, construct informative figures, and present to diverse audiences.
Experience contributing to core study documents.
Able to safeguard patient safety in clinical studies, including identifying trends in AE and lab data, reviewing SAEs and AESIs, developing risk mitigation strategies, and understanding when to escalate to the Medical Monitor.
Self-motivated; demonstrated success in delivering assigned tasks according to timelines.
Demonstrated history of creative problem-solving and learning agility.
Effective collaboration with as well as ability to impact and influence cross-functional teams and, in selected situations, senior leaders.
PhD, PharmD, RN, or MD; relevant BS or MS with extensive professional experience.
5+ years of pharmaceutical industry experience with at least 1-2 years of clinical development 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.

Desirable

Strong publication and presentation record.
Experience supporting interactions with global health authorities.
Background in immunology and experience developing immunotherapeutics.
Experience working with CROs including providing oversight.
Experience incorporating, implementing, and evaluating translational endpoints.
Experience integrating complex clinical and translational data to support dose selection.


This job has expired.

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