We are building out a best-in-class Regulatory Science team to support R&D as well as digital solutions including digital therapeutics, which will be part of the future of measurement science and analytics to support novel endpoints/interventions.

Evinova is a health-tech business, accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, from the inside. Through our application of science-based expertise, evidence-led rigour, and human experience-driven insight, our digital solutions are deliberately designed so that everyone can reach better health outcomes together. Evinova is a health-tech business within the AstraZeneca Group.

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, 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.

Digital health, the point at which healthcare, technology, data and analytics converge, is the subject of great promise, with the World Health Organisation believing it has the potential to improve health for everyone. At AstraZeneca, we've been working hard to make this a reality, with the years of experience we have accumulated enabling us to now embed digital health at scale across R&D. To achieve our goal of improving patient experience and outcomes AstraZeneca has Digital Health as one of the top 4 strategic priorities for the company, details on digital health strategy can be found here. Oncology is the largest therapeutic area within AstraZeneca and second highest cause of death globally, with AstraZeneca's ambition to eliminate cancer as a cause of death.

Senior Director Regulatory Science, Strategy, and Policy will provide strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned product(s). The successful candidate will be responsible for developing and implementing regulatory strategies for digital health technologies, clinical outcome assessments (COAs), and novel endpoints in drug development. The Senior Director will be expected to build a regulatory framework that accelerates generation and use of data/multi-modal evidence for medical product development and will involve working closely with cross-functional teams to ensure that regulatory requirements are met throughout the development process. As regulatory policy is essential to enable innovation, the Senior Director will be responsible to identify and prioritize business needs to inform policy solutions, monitor the policy environment to communicate trends internally and assess implications to business and build relationships and communicate priorities to key stakeholders. The Senior Director should be published as an expert within this area of specialization.

What you'll do

As the Senior Director, you will play a pivotal role in leading our scientific capabilities to make a positive impact on changing patients' lives through the following:

Develop and implement regulatory plans, strategies and approaches for integrating digital health technologies into research.

Collaborate and communicate closely with cross-functional teams to ensure that regulatory requirements are met throughout the drug development process.

Own the relevant regulatory activities and provide strategic input on key development and regulatory documents. Ensure global regulatory plans supporting digital approaches, including regulatory submission plans, health authorities (HA) engagement plans and mitigation strategies.

Stay up-to-date with relevant regulatory guidelines and developments in the field of digital health technologies and drug development.

Ensure high quality collaboration with global regulatory leads and provides guidance to the regional strategists in strategic meetings with health authorities.

Represent the company in regulatory interactions with health authorities.

Advise teams on payer standards for reimbursement of digital health technologies including evidence generation and real world evidence expectations.

Drive external engagement opportunities and contribute to relevant publications and external speaking events.

Influence improvement to the external environment through advocacy initiatives representing Evinova interests to health authorities and standards organizations directly and via industry coalitions

Minimum Qualifications:

Combination of academic training and practical experience in regulatory affairs experience or related knowledge/experience. This may consist of:

Masters degree in a related discipline, plus 10 years practical experience OR

Bachelors degree in a related discipline, plus 12 years practical experience

Extensive knowledge of digital health technologies in drug development.

Maintain an established network of policy experts at peer companies and industry groups

Previous demonstrated experience of regulatory drug development or equivalent, and experience with major Health Authority interactions (US or Ex-US)

A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.

Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.

Strong communication, negotiation, and problem-solving skills.

Ability to work effectively in cross-functional teams and manage multiple priorities.

Excellent organizational and project management skills.

Strong attention to detail and ability to work independently.

Creative, innovative, and solution-focused

Curious, embraces new ways of problem solving, new ideas, and new ways of working

Desirable Qualifications:

Advanced degree is preferred.

Prior experience with phase 3 design including end of phase 2 health authority interactions is preferred.

A good understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.

Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.

Ability to work strategically within a complex, business critical and high-profile development program.

Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components.

Understanding of strategic and tactical roles and deliverables of Global Regulatory Strategy in digital health technologies for drug development and investigation

Diligence - attention to detail and ability to manage a program of concurrent activities

Resilience - ability to overcome and motivate others in the face of a changing environment

Why Evinova (AstraZeneca)?

Evinova draws on AstraZeneca's deep experience developing novel therapeutics, informed by insights from thousands of patients and clinical researchers. Together, we can accelerate the delivery of life-changing medicines, improve the design and delivery of clinical trials for better patient experiences and outcomes, and think more holistically about patient care before, during, and after treatment. We know that regulators, healthcare professionals, and care teams at clinical trial sites do not want a fragmented approach. They do not want a future where every pharmaceutical company provides its own, different digital solutions. They want solutions that work across the sector, simplify their workload, and benefit patients broadly. By bringing our solutions to the wider healthcare community, we can help build more unified approaches to how we all develop and deploy digital technologies, better serving our teams, physicians, and ultimately patients. Evinova represents a unique opportunity to deliver meaningful outcomes with digital and AI to serve the wider healthcare community and create new standards for the sector. Join us on our journey of building a new kind of health-tech business to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting-edge methods, and bringing unexpected teams together.

So, what's next!

Are you already envisioning yourself joining our team? Good, because we can't wait to hear from you.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Learn more about Evinova www.evinova.com

The annual base pay for this position ranges from $225,068 to $337,603. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

01-Oct-2024

Closing Date

31-Oct-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.