Job Details : Associate Director - Clinical Ops Infectious Disease and Autoimmune Asset Lead
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Vacancy Name : Associate Director - Clinical Ops Infectious Disease and Autoimmune Asset Lead
Vacancy No : VN345
Employment Type : Full Time
Location of role :
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 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.
Key Responsibilities :
- Accountable for the operational delivery of Clinical Program Managers (CPMs) and their programs, ensuring all program deliverables and milestones are met with quality and within budget.
- Collaborate with cross-functional counterparts to oversee the performance for all activities to deliver programs on time and with quality.
- Participate in program strategy meetings, contributing the operational strategy of program / studies.
- Provide direction and support to CPMs for the development of study strategy operational plans including enrolment models and risk management strategy.
- Review and provide expert clinical operations input into clinical documents related to the drug development process.
- Support efforts for the selection and oversight of external service providers, including Contract Research Organizations (CROs).
- Oversight of team’s study execution and procedures as required to ensure regulatory compliance of protocol activities.
- Support Clinical Program budget negotiations and management of Clinical Operations spend related to clinical program execution.
- Play an active part in CRO selection and review of RFP’s when required.
- Identify and communicate study issues that will impact budget, resources and timelines.
- Ensure documentation is completed in accordance with GCP regulatory requirements.
- Participate and / or lead governance committee with Vendors.
- Ensure program meets all GCP / ICH Guidelines and is Inspection Ready.
Other Duties :
- Leads and / or contributes to department initiatives and assists in the design and implementation of standardized work processes.
- Provide expert and collegiate support to other members of the drug development team.
Experience & Knowledge :
Essential :
- Worked to fully understand and apply the principles of effective clinical project practices.
- Provided a strong clinical operational focus whilst being able to identify program needs.
- Vendor Oversight experience.
- Expertise in global regulatory and compliance requirements for clinical research.
- Demonstrated excellence in project / program management and matrix leadership.
- Creating and maintaining healthy relationships with study sites and principal investigators.
- Experience presenting high-level presentations.
- Ability to work independently.
- Ensure an enthusiastic and open attitude towards continuous professional development.
Desirable :
Experience in infectious disease and autoimmune disease would be an advantage.
Education & Qualifications :
- BA / BS. or higher in science related field.
- At least 10 years relevant experience in a biotechnology / pharmaceutical industry.
Work authorization and a valid passport is required for this role.
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