- Accountable for the operational delivery of 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. Ensure consistent approach and process across the portfolio.
- Review and provide expert clinical operations input into clinical documents related to the drug development process including study synopsis & protocols, clinical study reports, monitoring plans, Communication plans and p project plans.
- Support efforts for the selection and oversight of external service providers, including Contract Research Organizations (CROs) and other vendors as necessary
- Review of study protocols and related study documents, as required, for operational execution.
- 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. Works closely with Global Project Managers, Outsourcing Management, and Finance to ensure on a regular basis that budgets are accurate.
- Play an active part in CRO selection and review of RFP's when required, ensuring the appropriate CRO is identified and properly vetted. Work with internal and external teams as required, ensuring the programs are initiated and managed in line with company strategy and key clinical and regulatory milestones
- Supports and participate in request and review of scope of works, budgets, vendor performance and issue resolution
- Identifies and communicates study issues that will impact budget, resources and timelines. Provides support/escalation point for study team leads as needed
- Ensures documentation prepared internally or by CRO(s) is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies/programs and consistently across the portfolio.
- Participates and or Leads governance committee with Vendors
- Ensure program meets all GCP/ICH Guidelines and is Inspection Ready
- 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 to ensure full success of the company's portfolio and regulatory milestones
- Assist in SOP and working instruction development, review and approval
- Worked to fully understand and apply the principles of effective clinical project practices, achieving agreed outcomes. Supporting and influencing key stakeholders where required for the successful delivery of projects
- Provided a strong clinical operational focus whilst being able to identify program needs and deliver practical, straight-forward, solutions which work first time
- Vendor Oversight experience
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP. Awareness of local country requirements is also required.
- Demonstrated excellence in project/program management and matrix leadership
- Understands and applies the principles of GCP, ICH, GDP and relevant CFRs is required
- Creating and maintaining healthy, creative, relationships with study sites and principle investigators; helping to support and influence where required
- Experience presenting high level presentations, both orally and in writing using organizational skills to complement this
- Ability to work independently
- Ensure an enthusiastic and open attitude towards continuous professional development
- Experience in infectious disease and auto immune disease would be an advantage
- BA / BS. or higher in science related field (biological science, pharmacy or other health related discipline)
- At least 10 years relevant experience in a biotechnology/pharmaceutical industry and/or clinical research organization, including majority of time in clinical study/project management.
- Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint) and ability to develop proficiency in relevant Immunocore IRT and EDC systems and programs
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Associate Director - Rockville, United States - Immunocore Limited
Description
Job Details:
Associate Director - Clinical Ops Infectious Disease and Autoimmune Asset Lead
Full details of the job.
Vacancy Name
Vacancy Name
Associate Director - Clinical Ops Infectious Disease and Autoimmune Asset Lead
Vacancy No
Vacancy No
VN345
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 Associate Director will be accountable to oversee a team of Clinical Program Managers (CPM) across an Asset or Assets ensuring their clinical programs are delivered to time, cost and quality.
They will provide operational expertise and strategic input to the development of the clinical development plans supporting the overall clinical strategy Phase I-III.
KEY RESPONSIBILITIES
OTHER DUTIES
Essential
o Experience in infectious disease and auto immune disease would be an advantage
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