Associate Director, Clinical Outsourcing - Clinical Operations
Immunocore

Job Info

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About the CompanyImmunocore (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 ResponsibilitiesAs the Associate Director of Clinical Outsourcing in Clinical Operations, you will ensure that relationships between outsourcing partners and study teams are running smoothly and efficiently. You will also be responsible for administering appropriate governance and oversight programs in order to monitor external provider performance, delivery and relationship health. This role will foster clear, consistent and open collaboration with Immunocore and service provider staff to ensure the most optimal solutions are achieved. This individual will engage and lead service provider relationships to support performance management and will be responsible for participating in and leading continuous improvement initiatives, which quicken or provide efficiencies in achievement of Immunocore's goals.

Responsibilities:

Defines and oversees the execution of complex outsourcing management and implementation strategy.
Directs the development, planning, prioritization, approval, implementation and compliance of on-going and upcoming outsourcing programs.
Work closely with Procurement to coordinate and manage all stages of contract lifecycle including risk management analysis, due diligence, requirements and information gathering, RFP preparations, selection, negotiation, and termination.
Recommends and implements outsourcing parameters regarding production and quality in support of business objectives.
Analyse and manage partner's performance to ensure financial and operational objectives.
Review key performance scorecards and seek feedback from key internal stakeholders. Address areas of concern effectively and provide recommendations to mitigate against poor performance.
Collaborate with management to prioritize prospecting efforts and lead follow-up.
Facilitate the creation and management of a preferred partner environment, enabling streamlined selection and strategic pricing negotiations with partners.
Lead and manage the development of standards for vendor interaction and processes.
Collaborate with Immunocore QA to arrange and manage response to audits.
Collaborate with Procurement to negotiate pricing and contract.
Liaise cross-functionally to troubleshoot and provide resolution to vendor issues.
Liaise with management and internal stakeholders on key projects.
May be responsible for other projects and responsibilities as assigned.
Drives continuous improvement activities and implementations across functional areas.

Qualifications:

Essential:
BA / BS or higher in science related field (biological science, pharmacy or other health related discipline).
7 - 10+ years Bio-Pharma industry experience with extensive knowledge of strategic sourcing and category management.
Strong working knowledge of the ICH and FDA guidelines and of the IRB/IEC regulations is expected.
Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint) and knowledge of CTMS, eTMF and other project management programs.
Exceptional negotiation skills: you are a tenacious problem-solver with a focus on building mutually beneficial relationships.
Excellent communication and ability to influence others.
Experience working with cross functional teams.
Strong computer skills required.
Ability to analyze and review data (in order to build evidence-based trial strategies).
Capable of multi-tasking and working well under pressure to meet deadlines coupled with a good understanding of working in a team environment.
Proven record of working effectively with and across business areas (lab operations, medical affairs, research & development, finance, regulatory, etc.).
Exercises solid and mature judgment to escalate issues in a timely manner.
Keeps management apprised of business-critical risks and proactively develops comprehensive mitigation plans.
Duties are typically performed in an office setting.
Duties may require working outside normal working hours (evenings and weekends).
Expertise and current training in Good Clinical Practice (GCP).
Strong project management, organizational and communication skills.

Desirable:
Previous healthcare experience is preferred.
Requires the ability to change the thinking of or gain acceptance from others in sensitive situations without damage to relationships.
Experience in the management and execution of clinical studies/trials/labs/ including management of vendors, central labs and/or CROs preferred.

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