Senior Director, Regulatory, Quality and Pharmacovigilance

Senior Director - RWE Innovation & External Partnerships page is loaded Senior Director - RWE Innovation & External Partnerships
Bewerben locations United Kingdom - Uxbridge posted on Vor mehr als 30 Tagen ausgeschrieben job requisition id R0039774 For Current Gilead Employees and Contractors:
For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.
Senior Director - RWE Innovation and external partnerships
With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development.
This position is office based at our Stockley Park or Cambridge sites in the UK
The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the Clinical Development organization and aims to unlock the power of Real-World Data (RWD) to help transform innovations to life-changing medicines for patients. The Senior Director, RWE innovation methods and external partnerships reports to the Executive Director, RWE Generation and is accountable for the development of expert enterprise capabilities in RWE analytics and study delivery in direct support of the execution of RWE strategies across all Gilead Therapeutic Areas (TA) throughout the development lifecycle.
The role will be responsible for ensuring that the company remains at the forefront of data driven drug development to ensure Gilead continues to deliver maximal impact for patients.
We are looking for an innovative, dynamic, entrepreneurial, strategic leader with a wide array of technical expertise including data science, epidemiology, drug development, AI and machine learning as well as an in depth understanding of the pharmaceutical industry, regulatory strategy and evidence generation.
Develop and articulate a comprehensive RWE innovation and external partnership strategy for RWE function aligned with company goals and industry trends.
Create and communicate a vision for RWE innovation and external partnerships within the organization.
Oversee the successful execution of RWD innovation methods projects, ensuring they are delivered on time, within budget, and meet quality standards and in addition the work being adopted for execution by relevant functions.
Serve on the RWE Generation Leadership Team and promote alignment of innovation initiatives across therapeutic areas. Develop and execute a cross-functional communication plan for RWE Generation Innovation initiatives. 
Contribute to RWE Generation budget planning, resource allocation, and reporting.
Provide strategic leadership to build and cement the RWE innovation methods and external partnerships as a core strategic partner for RWE generation across the organization.
RWE Innovation and Research:
Promote a culture of innovation, encouraging creative thinking and exploring novel ways to harness RWD for scientific advancement.
Collaborate with academic and industry partners to stay at the forefront of RWD innovation.
Lead a team of scientists to leverage RWD for development of innovative approaches to support data-driven decision support and evidence.
Drive the development of advanced methods such as machine learning and AI algorithms to extract meaningful insights from complex healthcare data.
Develop strong relationships with internal and external RWE ecosystem partners to allow evolution of data sources, methodological and technological interests.
Evaluate membership and ensure Gilead's involvement in national and international organizations working at the intersections of pharmacoepidemiology, data science, and regulatory science.
Collaborate closely with internal stakeholders (e.g. medical affairs, commercial, RWE, clinical operations, clinical development, corporate strategy, portfolio strategy) to identify and execute on opportunities for the innovative and high-impact use of RWD and analytic technology throughout drug development stages.
Regulatory Compliance:
Stay informed about evolving regulatory requirements with regard to use of observational research in the life sciences sector, ensuring that conduct of RWE practices comply with regulatory and scientific expectations and guidelines.
Manage the development of Gilead's position on the use of RWD/E for decision-making (including use for Regulatory decisions), coordinate Gilead's commentary to regulatory agencies and/or industry groups and represent the RWE function in pertinent interactions.
Oversee the recruitment, expansion, and retention of an expert RWE innovation and methods teams by providing clarity of purpose, commitment to professional development, and focus on methodological rigor and execution excellence.
Mentor Innovation Unit staff and build a culture of accountable and high-impact leadership.
PhD, MD, ScD, PharmD) and/or Master’s degree (e.g. MSc) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution with significant relevant experience in the biopharmaceutical industry, with direct involvement in the analysis of RWD and generation of RWE.
Demonstrated leadership in driving innovation and strategic thinking.
Exceptional communication and stakeholder management skills.
Demonstrable experience of innovative uses of data including RWE, commercial and clinical trial data to deliver real business impact across the organisation.
Experience of leading impactful innovations in drug development, life cycle management, integrated evidence planning and HTA negotiations.
Experience in influencing key stakeholders within the organisation & conceptualising and leading a successful change management program.
Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. Inclusion (encouraging diversity)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). For Current Gilead Employees and Contractors:
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locations United Kingdom - Uxbridge time type Full time posted on Vor 18 Tagen ausgeschrieben Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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