Senior Director, Head of Regulatory Science, Strategy, and Policy - Evinova

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.

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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.

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.

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

Learn more about Evinova at www.evinova.com.

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