*Title:* *TA Evidence Strategy Lead*
*Location:* *Cambridge, UK | Gothenburg, Sweden | Gaithersburg, US | Wilmington, US *
*Salary:* *Competitive salary offered **Posting Date:* *Open 1st April 2021 Close 15th April 2021*
Role Description:At AstraZeneca, we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being ambitious, thinking big, and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person!
*Job Description*The Evidence Strategy Lead, Infection is a new strategic, scientific position within the Global Biopharmaceuticals Medical organisation, accountable for the strategy and execution of evidence generation plans that support Medical, Pricing and Market Access and Policy standards strategies for AstraZeneca medicines within our growing infection portfolio.
The role requires interaction with diverse range of scientific, technical and business specialists to ensure scientific quality and timely delivery of real world data that addresses critical business needs. The role necessitates close working with partners in Brand-aligned Medical Affairs, Market Access, commercial teams as well as the clinical development team to identify critical evidence gaps and develop real world evidence generation plans that will enable enhanced access to AstraZeneca medicines, define national quality standards and policy, and and ensure support for appropriate target claims and messages. This role also collaborates with safety/pharmacovigilance epidemiology lead responsible for strategic planning and execution of postmarketing safety studies in collaboration with Patient Safety.
The Infection Evidence Strategy Lead will manage and develop a team of epidemiologists, optimizing individual and team performance, ensuring appropriate deployment to drug projects and other functional activities according to business priorities to build and maintain excellence in epidemiology capabilities. This position has management responsibilities for a wide range of activities, including competence development, training, optimal use of resource and skill, and systematic implementation of new methodologies in epidemiological and observational research. The incumbent will drive recruitment, retention, resource planning, development, and people management of Epidemiologists to deliver the agreed project objectives.
The Director of Clinical Development (DCD) sits within Clinical Operations of Late Stage Oncology R&D and is accountable for leading the Clinical Program Team (CPT), a strategic and operational leadership team. You will be responsible for program leadership of all Late Stage clinical development deliverables (scope, quality, budget, time, resource and risk). The role involves integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs that align with AstraZeneca priorities and strategy. The DCD brings product knowledge and critical thinking to support governance interactions, lead the delivery of a program of studies and co-ordinate the delivery of the clinical components of Health Authority submissions and documents. You will:
These responsibilities require an extensive experience within the pharmaceutical industry, with broad and deep knowledge of medical evidence generation methodologies and how they relate to product development and commercialization processes at all life-cycle stages as well as the ability to influence internal partners and external stakeholders. The successful candidate will have significant experience of generating impactful real world evidence utilised by payers and regulators and be able to demonstrate strong leadership capabilities.
*Typical Accountabilities *Through leadership of the Epidemiology Pharmacovigilance team as well as individual contribution:
* Ensure the development and delivery of high quality, scientifically robust evidence strategy and deliverables on time and on budget.
* Ensures effective resourcing of projects across disease area
* Lead the recruitment and allocation of appropriately skilled Epidemiologists to projects to ensure delivery of value evidence to clinical programs to time, budget and quality in accordance with performance targets
* Work closely with different leadership team across the organisation
* Drive forward innovative ways to deliver evidence, including methodologies, partnerships, delivery modalities.
* Develop and maintain an Epidemiology skills development strategy, proactively identifying and delivering against gaps (e.g., define training needs and capabilities improvement/maintenance activities)
* Work with Capacity Management to achieve accurate resource forecasting, analysis and solution building to resource projects efficiently and flexibly, considering people development and succession planning
* Ensure individuals are motivated, skilled and developed, providing expertise and guidance to support creation and implementation of relevant Individual Development Plans
* Act as an ambassador for GMA functions, providing clarity on the roles and delivering appropriate advocacy whenever possible to ensure company-wide understanding and best usage of the function
* Ensure compliance with policy and SOPs
* Provide technical and strategic input to projects via coaching of direct reports and through leadership review of deliverables (e.g., ERT, MARC)
* Supports the TA Evidence Head in establishing a close collaboration and interaction with relevant functions in TA (Evidence Leads, BPM, BBU, R&D, and MCs to develop AstraZeneca’s approach to plan for and meet the needs of regulator, payers, physicians and patients
* Provides expert line management and mentor of Epidemiologists to continuously raise level of competence for AstraZeneca
* Ensure close collaboration with regions and MCs to guarantee strategic alignment and improve resources.
* Advances AstraZeneca’s reputation and expertise in Epidemiology policy, planning and evidence generation by participating in appropriate external forums e.g., special interest groups of relevant organizations
* Line management of the members of the Epidemiology team
* Promote and encourage communication within and across departments
* Recruit, retain and develop personnel through skills development and creation of opportunities for related staff
* Provide performance management, performance assessment and reward proposals for direct reports
* Ensure policy administration and implementation within the organization
* Maintain an environment that attracts, develops and retains highly qualified employees
* Ensure that SHE standards are adhered to for direct reports including appropriate work-life balance.
* Carry out effective succession planning
* The TA Evidence Strategy Lead will manage a team of epidemiologists as well as contract resources as needed. The Evidence Strategy Lead will also work on individual studies.
*Education, Qualifications, Skills and Experience*
* Master’s degree OR Ph.D.
* University degree in Epidemiology or Public Health, or related subject area such as Health Outcomes Research.
* Therapeutic and disease area knowledge and knowledge of drug development and life cycle management
* Extensive experience working with primary and secondary data, both US and global. Preferred experience with pragmatic trials.
* In-depth specialist knowledge of epidemiology and its application to support pharmaceutical development, regulatory approval and patient access at an international level
* Experience in utilizing real world and other data to support value-based outcomes collaborations with health care providers and reimbursement authorities
* Experience in supporting Global Reimbursement Dossiers and Global Value Packs and utilizing Real World Data to support Payer needs
* Relevant experience, including a experience in the pharmaceutical/biotechnology.
* Comprehensive knowledge of clinical and commercial drug development processes
* Ability to interact externally with key customers, including congress presentations.
* Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment
* Experience, leading, promoting, motivating and empowering others to accomplish individual, team and organisational objectives
* Ability to influence strategically and persuade thoughtfully, to obtain desired outcomes while maintaining effective, positive organisational relationships
* Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment
* Dedicated teammate
* Able to influence others at a senior level across the business in order gain commitment to strategy
* Proven teamwork and collaboration skills
* Well-developed cultural sensitivity
* Effectively represents the company externally to key stakeholders
* Experience of infectious disease epidemiology particularly in relation to vaccines
* Experience leading and managing in a global, matrix environment, including direct personnel management.
* Effective project and budget management experience
* Experience of managing change – manages change with a positive approach to the challenges of change for self, team and the business
* Experience in digital health
* Experience in social media research
* Knowledge of conducting patient experience studies