- Assure clinical development plans are comprehensive, include key decision points, timely readouts, and risk mitigation for both near and long-term goals
- Design high quality & innovative clinical trial protocols (including all supporting documents such as Investigator's Brochure, informed consent, etc.) for lead Oncology target programs that are aligned with the Clinical Development Plan and overall product strategy
- Provide medical oversight of clinical studies, implementation, medical/safety monitoring, medical data review, results interpretation, and reporting for assigned studies
- Provide strategic clinical leadership to development teams, including generation of integrated product development plans that incorporate scientific rationale, regulatory input, and advice from medical, patient advocacy groups and payors appropriate for assigned studies
- Help build and manage the relationships with relevant CROs, facilitate thorough understanding of clinical studies, assist in patient recruitment, and help assure trials are executed on time and within budget
- Contribute to the regulatory strategy, preparation, and review of regulatory submissions, response to IRB/EC questions, and participate in global health agency meetings
- Contribute to the development of publication plans, present clinical data at key meetings and publish in high-impact journals
- Contribute to Business Development activities as requested
- Strategic and critical thinker, with proven success in designing innovative clinical trials that have supported successful regulatory filings
- Established links with the medical community globally and locally, with proven ability to develop close working relationships with opinion leaders
- 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 contributing to the development of key clinical documents (e.g., protocols, ICF, IB, DSUR, CRF) and ability to review and interpret clinical data
- Broad understanding of oncology disease area; experience in immuno-oncology highly desirable
- At least 3 years of relevant experience in clinical drug development across academia or pharmaceutical industry (must include experience conducting early phase trials)
- At least 2 years of experience as a medical monitor in a biotechnology/ pharmaceutical company, and/or CRO.
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Physician Director - United Kingdom - Immunocore
Description
Director, Physician - Clinical Development, Early OncologyVacancy Name Director, Physician - Clinical Development, Early Oncology
Employment Type Full Time
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 Responsibilities This role will contribute to advancing both the oncology programs in various stages of development and the fabric of Immunocore's clinical sciences.
The successful candidate will lead and facilitate Clinical Development strategic planning and be accountable for the design and medical oversight of clinical studies, including protocol development, medical monitoring, medical data review, results interpretation, reporting and regulatory submissions.
In addition, they will lead innovation in trial design, including development of biomarker strategies.This role will be a key in-house oncology disease area expert for R&D and requires leadership, advising, and close collaboration with members of cross-functional teams.
The position will interact with all levels of management, peers and leaders from academic centers involved in key collaborations, external stakeholders in the medical and scientific community, along with global regulatory authorities.
This position can be located at any of our US & UK office locations (Rockville MD, Conshohocken PA, Abingdon UK).
Lead and shape future clinical development strategy and clinical development plans, working closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Non-clinical and Discovery Research for assigned studiesThe ideal candidate is an MD or MD/PhD scientist with a clinical perspective, coupled with a track record of exceptional achievement in oncology therapy development.
Strong understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements and demonstrated experience integrating these disciplines in the context of drug development.
This position is eligible for standard Company benefits, including medical, dental, vision, time off and 401k, as well as participating in Immunocore's annual incentive plans.
Incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level.US remote
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