Associate Director, Clinical Operations

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details
Location of role Rockville, Conshohocken
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. 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 The Associate Director, Clinical Operations will be accountable to oversee a complex oncology study or program of studies and cross functional teams ensuring the program/study is delivered to time, cost, and quality.
Key Responsibilities
  • Accountable for the operational delivery of one or more complex programs or studies, ensuring the program/study deliverables and milestones are met with quality and within budget
  • Be the key point of contact for assigned program/studies in the operational team for portfolio leaders
  • May participate in program strategy meetings, contributing the operational strategy of program/studies.
  • Lead and collaborate with cross-functional team to oversee the performance for all activities to deliver the program/study on time.
  • Create strong strategic partnerships with colleagues in cross functional team members to ensure consistent approaches to program/study delivery, data collection and reporting across a program.
  • Provide direction and support to Clinical Operations team members. Develop the program/study strategy operational plans including model scenarios for optimal program/study delivery linked to value drivers and implications on time, quality, risk and budget.
  • Review and provide expert Clinical Operations input into clinical documents related to the drug development process including study synopsis & protocols, clinical study reports, and all project plans.
  • Provides regular executive updates to senior management.
  • Oversee delivery quality, ensure inspection readiness at all times and interact regularly with Program/Study team members around issues / risks / successes with study delivery as they occur.
  • Support study budget negotiations and management of Clinical Operations spend related to study execution. Works closely with Outsourcing Management, Finance, and Clinical Operations Leadership to ensure budgets are accurate.
  • Play an active part in external service provider selections, including Contract Research Organizations (CROs) and other vendors as necessary. Ensure the appropriate CRO is identified and vetted and managed through the life of the study.
  • 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.
  • Proactively identifies and communicates program/study issues that will impact budget, resources and timelines. Escalates as appropriate.
  • May participates in governance committee with Vendors.
Other Duties
  • May lead 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
Experience & knowledge
Essential
  • 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
Desirable
  • Experience with immunotherapies in Oncology would be an advantage
Education & Qualifications
  • 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.
  • Experience must include early phase clinical studies/Phase I-III studies and global/international studies or programs
  • Experience in oncology is highly desired.
  • 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
Work authorization and a valid passport is required for this role.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

Experience:

  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 11, 2024
Company Overview
Immunocore
Immunocore

Current Openings: 0

Immunocore is a leading T cell receptor (TCR) biotechnology company working to create first-in-class biological therapies to address unmet patient needs in oncology as well as infectious and autoimmune diseases. See our community guidelines: http://bit.ly/2kFA8hr
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