- 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, Medical Affairs, Commercial, Non-clinical and Discovery Research for assigned studies
- 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
- Establish and maintain strong relationships with key opinion leaders and partners, to facilitate and support external collaborations
- 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
- Demonstrated ability to build mutually respectful relationships with colleagues. Trouble shoot challenges and provide direction, guidance, and support to the team to deliver on near term goals
- The 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.
- 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
- Strong communication skills, professional presence, and ability to engage effectively with stakeholders at all levels
- Collaborative and able to motivate and energize cross functional team members to achieve aggressive goals
- Strong problem-solving, and analytical skills, able to facilitate discussions among groups with diverse technical expertise, and progress decisions on low to moderate complexity issues
- 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 contributing to the development of key clinical documents (e.g., protocols, ICF, IB, DSUR, CRF) and ability to review and interpret clinical data
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Senior Director, Physician - Rockville, United States - Immunocore Limited
Description
Job Details:
Senior Director, Physician - Clinical Development, Late-Stage Oncology
Full details of the job.
Vacancy Name
Vacancy Name
Senior Director, Physician - Clinical Development, Late-Stage Oncology
Vacancy No
Vacancy No
VN376
Employment Type
Employment Type
Full Time
Location of role
About the Company
About the Company
Immunocore (
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.
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 ResponsibilitiesKey Responsibilities
The Senior Director, Physician - Clinical Development, Late-Stage Oncology will contribute to advancing both the oncology programs in predominantly in mid to late 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 centres involved in key collaborations, external stakeholders in the medical and scientific community, along with global regulatory authorities.
KEY RESPONSIBILITIES
IMMUNOCORE VALUES
Annual salary range:
US remote
$300,000 - $320,000
#LI - remote
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