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Director, Scientific and Government Affairs

3 months ago


Abingdon, Oxfordshire, United Kingdom BioLegend, Inc. Full time

This is a fixed term maternity cover of circa 12-13 months.

Job Summary

The Scientific and Government Affairs role is responsible for driving the scientific narrative of the Revvity Infectious Diseases Diagnostics (IDx) business unit and the Revvity IDx range of products, and for ensuring scientific integrity throughout product development and commercialisation. The role will also be responsible for developing and implementing strategic medical/scientific plans for engagement, insight gathering and communications. This candidate will ultimately inform Revvity IDx's strategic decisions, by ensuring that decisions made are medically accurate, clinically relevant, procedurally safe and patient-focused. This requires scientific expertise, as well as knowledge of critical unmet patient needs, and key challenges that exist within global healthcare systems.

The Scientific and Government Affairs role is responsible for three key areas:

Developing, implementing and executing the scientific strategy globally for Revvity IDx

A key role is to create scientific strategies and narratives for Revvity IDx's range of products, both pre and post commercialisation, and promote the scientific rationale of all Revvity IDx's products and pipelines. In addition the role will contribute to the development of new products by providing scientific and clinical insights into the validity and use cases of suggested workstreams, as such helping to drive business outcomes.

Driving Government Affairs and engagement activities

This involves developing a strategic plan to enhance the position of Revvity IDx products in global and country-specific guidelines, and drive policy change. The role will be responsible for developing and maintaining relationships with guideline creators, government officials and policy influencers, including but not limited to the WHO, FIND, the Global Fund, Stop TB, the CDC, NICE and country specific ministries of health.

Compliance Oversight and implementation

This role will also participate as a core member of the Investigator Led Study Committee and the Grants and Compliance Committee. The role is critical to the review of marketing and external facing materials for Revvity IDx, and acts to mitigate any potential compliance risks as part of it's daily responsibilities. A comprehensive understanding of the regulatory and compliance space is required to ensure that this role maintains a consistent, transparent and appropriate relationship with key opinion leaders and organisations.

Key Responsibilities:

Scientific strategic planning

  • Defining global scientific strategy plans for existing and novel products, ensuring alignment with commercial strategy (product Life Cycle and other key strategic plans)
  • Perform regular data gap analyses to identify where Revvity IDx needs to strengthen their clinical evidence to support commercialization
  • Develop and execute clinical and scientific plans to acquire data – e.g. study collaborations, peer-reviewed publications, internal data searches etc.
  • Implement scientific/clinical messaging and educational plans aligned to the Revvity IDx strategy, and advocate for the companies products internally, and to external healthcare professionals, scientific leaders, and key decision-makers
  • Direct all scientific and medical product communications appropriately, driving the generation and dissemination of scientifically accurate data through publication plans, webinars and congress symposia
  • Contribute to the development of new products by providing scientific and clinical insights into the validity of use cases of suggested workstreams
  • Synthesise complex market and/or product information and distill key learnings and insights into meaningful, actionable and strategic recommendations

Scientific business development

  • Consult with leading medical and scientific experts in the field to understand product positioning and growth, and the critical unmet patient needs
  • Guide commercial teams with scientific knowledge and strategy to advance Revvity IDx business and build company credibility
  • Work cross-functionally to contribute to the development of novel, proof-of-concept diagnostic tests
  • Provide independent scientific support, opinions, and initiatives to development, regulatory, marketing and clinical projects in order to meet company strategic goals

Government affairs and TB community engagement

  • Collaborate with wider Revvity group Government Affairs to develop cross-functional strategic plans for enhancing the position of Revvity IDx products in guidelines and policies
  • Develop understanding of how to influence guidelines and government-driven tender processes
  • Provide educational materials and support governments in implementing the use of Revvity IDx products
  • Develop relationships, share knowledge and gather insights from guideline creators, government officials and policy influencers e.g. the WHO, the Global Fund, FIND, Stop TB.
  • Plan and execute Scientific Advisory Boards with key stakeholders and thought leaders to direct to development of Revvity IDx product lines
  • Develop public relations materials for communicating key milestones, scientific information and events through close collaboration with Revvity IDx products, and wider relevant scientific developments

Scientific education strategy

  • Develop and execute and external scientific communications strategy with relevant content to support commercial communications strategy and execute in partnership with Mar Comms
  • Manage and provide content for the Revvity IDx scientific blog
  • Develop and implement a strategic internal educational plan including scientific/clinical onboarding, upskilling and modular training
  • Develop and implement a strategic external educational plan including webinars, symposiums and educational events
  • Act as expert speaker at internal and external events to represent Revvity IDx scientific and clinical opinions globally
  • Manage and provide content for coaching briefs and associated training to keep commercial teams up to date with recent updates
  • Champion the needs of patients and clinicians within the company and educate staff on the impact of the companies products on human life e.g. patient advocacy and amplifying patient stories

Compliance oversight and implementation

  • Participate as critical member of the Investigator Led Study committee, reviewing and evaluating requests for study support and funding from the perspective of scientific merit and global and regional compliance
  • Act as final reviewer on all marketing and external facing materials produced by Revvity IDx, and intervene to identify and mitigate any potential compliance risks regarding scientific claims or content
  • Participate in the Grant and Compliance Committee to evaluate requests for funding for educational grants and evaluation of scientific congress sponsorship for scientific merit
  • Ensure ethical and compliant conduct with organisations, individuals and collaborating groups whilst supporting the needs of the company

Qualifications

Required:

  • Requires a Ph.D. in Cell Biology, Immunology or similar
  • Significant experience in a scientific or medical affairs role in a diagnostic or pharmaceutical company
  • A minimum of 2+ years of relevant research and laboratory experience in medical science in the academic sector
  • Experience with clinical study design and implementation
  • Strong working knowledge of regulations in the medical device and pharmaceutical industry
  • Experience with project management

Preferred:

  • Proficient in statistical software tools: GraphPad Prism etc.
  • Line management experience

Skills and abilities:

  • Strong business acumen
  • Excellent communication skills
  • Excellent management and organisational skills
  • Proven project management, time management, organisation and prioritisation skills
  • Ability to travel locally and internationally, approximately 20% of the time
  • Ability to work in a fast-paced environment and simultaneously manage multiple competing tasks
  • Ability to work independently, take initiative and complete tasks to deadlines
  • Ability to function as a team player with strong interpersonal skills

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