Executive Director, Early-Stage Clinical Development, Oncology
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Job Details: Executive Director, Early-Stage Clinical Development, Oncology Full details of the job.
Vacancy Name: Executive Director, Early-Stage Clinical Development, Oncology
Vacancy No: VN616
Employment Type: Full Time
Location of role: Gaithersburg, MD, US,
Find out if this opportunity is a good fit by reading all of the information that follows below.
Conshohocken, PA, US
Oxford, UK
Department: Clinical Development
Key Responsibilities The Executive Director, Early-Stage Clinical Development, Oncology will drive assigned oncology programs from pre-clinical stages to proof of concept. They will also contribute to the development of infrastructure within Immunocore’s Clinical Sciences department by leading designated projects and workstreams.
The successful candidate will spearhead Clinical Development strategic planning and be responsible for the design and medical oversight of assigned clinical studies. This includes protocol development, medical monitoring, medical data review, results interpretation, reporting, and regulatory submissions. Additionally, they will lead innovation in trial design, including the development of biomarker strategies.
The incumbent is expected to think strategically at both the program and enterprise levels, with the ability to analyze data, troubleshoot programs, and develop risk mitigation plans.
As a key in-house oncology disease expert for R&D, this role requires strong strategic leadership, advisory skills, and close collaboration with cross-functional teams whilst providing oversight, guidance, and mentorship to junior physicians leading early-stage clinical trials.
The Executive Director will interact with all levels of management, peers, and leaders from academic centers involved in key collaborations, as well as external stakeholders in the medical and scientific community and global regulatory authorities. The incumbent will work with outstanding people who together pioneer the research, development, and commercialization of bi-specific TCR therapies.
Experience and Knowledge The ideal candidate is an MD or MD/PhD scientist with a clinical perspective, a track record of exceptional achievements in oncology therapy development and expertise in multiple disease areas. They have:
Thorough understanding of the early drug development process including experience contributing to key clinical documents (e.g., protocols, ICF, IB, DSUR, CRF), reviewing and interpreting clinical data.
A strategic and critical mindset with strong problem-solving and analytical skills, as well as a proven ability in designing innovative clinical trials that have supported successful regulatory filings.
Expertise in presenting key headline data with professional authority, anticipating and addressing questions/concerns from senior leadership in a governance setting.
Established links with the medical community globally and locally, with proven ability to develop close working relationships with opinion leaders.
Working knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA, EMA, and CHMP regulations and guidelines and other international regulatory requirements is a plus.
Solid working knowledge of Microsoft applications such as Excel, Access, Word, and Outlook.
Leadership and Stakeholder Management Demonstrated ability to build mutually respectful relationships with colleagues, troubleshoot challenges and provide direction, guidance, and support to the team to achieve near-term goals.
Ability to facilitate discussions and collaboration among groups with diverse technical expertise, gain alignment and progress decisions on moderate to high complexity issues.
Capable of providing clear direction and holding teams accountable to deliver timely execution of objectives. Motivate and energize cross-functional team members to achieve aggressive goals.
Strong oral and written communication skills, professional presence, and demonstrated ability to engage effectively with stakeholders at all levels including senior leaders.
Foundational people management skills with the ability to oversee and manage the activities of junior physicians and clinical scientists, mentor colleagues, and bring the Immunocore vision and strategy to life for others at all levels.
Education and Qualifications The ideal candidate is an MD or MD/PhD, ideally with oncology training.
5-8 years of relevant experience in clinical drug development OR 2-5 years of relevant clinical development experience with 5-10 years in clinical practice in a related field.
At least two years of experience as a medical monitor in a biopharmaceutical company, and/or CRO.
Strong understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements and demonstrated experience integrating these disciplines in the context of drug development.
A broad understanding of oncology disease area; experience in immuno-oncology is highly desirable.
Behavioral Attributes Role Specific:
Diagnostic Information Gathering: Effectively identifies the information required to clarify a situation and asks pertinent questions when necessary.
Results Oriented: Focuses on achieving desired outcomes and proactively seeks support to overcome obstacles in a timely manner.
Thoroughness: Ensures completeness and accuracy of all work, carefully checks and seeks support when necessary.
Managing Self Performance: Works to specific and measurable goals, seeking support and advice with unfamiliar or new issues.
Analytical Thinking: Uses a logical, systematic approach to tackle day-to-day problems and identify discrepancies or inconsistencies.
Corporate Behavioral Attributes:
Openness and Honesty – Readily offers information pertaining to work, whether positive or negative.
Taking Responsibility – Accepts full responsibility for tasks entrusted to them, sees them through to completion and deals with the consequences of failure or success.
Flexibility – Demonstrates flexibility to new ideas and approaches, changes in plans, objectives and priorities; handles disjointed tasks effectively.
Team Spirit – Works productively with others, considering their needs and feelings.
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.
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.
Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
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- Location:
- PA
- Salary:
- $125
- Job Type:
- FullTime
- Category:
- Healthcare And Medical