If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As an AssociateDirector, Clinical Operations- Cardiovascular & Metabolic Disease (CVMD) in Gaithersburg, US or Granta Park, UK, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.Main Duties and Responsibilities
As the Associate Director, Clinical Operations CVMD, you will represent clinical operations on the Product Development Team (PDT) and/or Global Product Team (GPT) and will be responsible for overseeing all operational aspects of a single or multiple development programs. You will provide the strategic operational input and design into the Clinical Development Plan. You may lead a portfolio of programs across a therapeutic area (TA) including late stage or very close to late stage assets in transition to Global Medicines Group for Phase III execution, as well as serve as the Clinical Operations Head of the TA, depending on the size and scope of the TA or assume responsibilities of Senior Director, COH as needed at senior level governance interactions. This position requires versatility to be an effective facilitator at various levels in the organization to solve problems by addressing root cause issues. You may lead cross Medi/AZ process improvement initiatives. You will work with senior management to establish directives for their groups and assure proper allocation and qualifications of internal and vendor resources for their portfolio. You will serve on vendor governance bodies to establish and track key performance indicators for deliverables significant to the success of the organization.
- Design the clinical operational strategy for the Clinical Development Plan (CDP) with Medical Director
- Provide expert clinical operational input into: Target Product Profile (TPP), Clinical Development Plan (CDP), Protocol Concept Sheet (PCS), Clinical Study Protocol (CSP), and Clinical Study Report (CSR), to ensure seamless delivery of studies through effective collaboration
- Deliver differentiated and robust operational design options for review at Investment Decision Governance interactions (ie. PDT, iMED, Clinical Functional Review, ESPC and others as appropriate)
- Oversee the operational delivery of the Clinical Study Program(s) from CD Nomination to final CSR and through to study closed and archived to agreed budget, time and quality and aligned with Key Performance Indicators (KPIs)
- Plan and lead interactions, including issue escalation and resolution between Clinical Operations, Clinical Trial Teams (CTTs), CST and the PDT/GPT
- Accountable for driving accurate clinical resource forecasting.
- Develop and manage clinical program risk and opportunity mitigation plans to ensure delivery to timelines, budget and quality with efficient resource utilization.
- Review of the CSRs and any regulatory submissions. Co-leads the clinical operational team contribution along with Regulatory
- Responsible for the initial forecasting and management of all Clinical Operations delivery related costs and oversight for individual studies
- Accountable for the quality of study delivery planning information into relevant planning systems (eg:, OPAL, IMPACT) and the direct input of clinical forecasting into OPAL
- Collaborate with Sr. Director, Clinical Operations and/or Sr. Director, Clinical Development or TA VP to drive best practices, ensuring project and functional objectives are aligned and cascaded to team members
- Partner closely with the Medical Director and other members of the CST, to, provide expert clinical operational feasibility input to PCS development.
- Accountable for overall program deliverables, will maintain oversight of compound’s study deliverables by close interaction with the CPMs who are assigned to the individual trials.
- Line management of AD/CPM/Sr CPMs.
- May act as a coach and/or mentor for other more junior staff as needed
- Bachelor of Science/Arts in medical biological science, business or finance or related
- Minimum 10 years of experience in the pharmaceutical/biotech industry
- Extensive and proven experience in driving operational delivery to timelines, cost and quality
- Proven experience leading delivery through collaboration with internal organization and external providers
- Significant experience and expertise in Clinical Trial methodology with a proven ability to deliver differentiated options based on a sound knowledge of operational delivery
- Proven ability in proactive problem solving and risk management that is solution focused
- Proven Global Project Management experience with expertise in program level resource and budget management
- Experience and strength in working and leading in matrix teams
- Requires minimal guidance and oversight from the Sr. Director, Clinical Operations and/or Sr. Director, Clinical Development or TA VP
- Strategic Skills including a high level of creativity, innovation, and problem solving with an ability to manage effectively through ambiguity
- Strong collaborative communications skills including the ability to engage with a diverse client base and manage through conflict
- Manages the Clinical Operations remit within the PDT and/or GPT structure
- Ability/willingness to lead strategic and/or operational management of individual clinical trials should the need arise
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