Director, Global Patient Safety Sciences Delivery - Rare Disease

Director, Global Patient Safety Sciences Delivery - Rare Disease

Full-Time 63000 - 77000 £ / year (est.) Home office (partial)
B

At a Glance

  • Tasks: Lead a team in ensuring safety data accuracy and compliance for rare disease operations.
  • Company: Join Regeneron, a science-driven company making a real difference in patients' lives.
  • Benefits: Enjoy competitive pay, health benefits, and opportunities for professional growth.
  • Other info: Collaborative environment with strong focus on leadership development and team building.
  • Why this job: Make an impact in global patient safety while working with innovative technologies.
  • Qualifications: Advanced degree in life sciences and 12+ years of experience in patient safety required.

The predicted salary is between 63000 - 77000 £ per year.

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director to join our Global Patient Safety Sciences Delivery team. The Director, Global Patient Safety Sciences Delivery, Rare Disease, serves as the first point of contact for all Rare Disease operations including safety data processing, submission creation, and documentation to ensure completeness, accuracy, and timeliness. This role is responsible for high quality, compliant execution of safety surveillance, signal management, and aggregate reporting activities across the portfolio.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Work Location: Uxbridge, UK - 3 days per week on site - 25% Travel may be required

Discover Your Role:

  • The Director is responsible for the development of their team, which is comprised of Safety Scientists.
  • The Director will also be expected to work closely with other Directors on driving standardization and consistency in execution of signal detection activities in partnership.
  • This role will report to the ED, Global Patient Safety Sciences Delivery.
  • Develop common practices, processes and templates to drive standardization and consistency in execution of core activities (e.g., signal detection, authoring sections for safety documents) across all products and TAs.
  • Ensure compliance and quality management of Safety Sciences Delivery activities, including compliance with all regulations and establishment of SOPs and associated monitoring tools.
  • Lead all aspects of signal detection coordination and signal management process across Rare Disease, including Safety Monitoring Team (SMT), Safety Surveillance Plan (SSP) and Signal Evaluation Report (SER).
  • Develop innovative approaches to delivering on core activities that integrate in new technologies.
  • Analyze aggregate safety data to identify emerging safety issues and patterns, in partnership with Safety Sciences Strategy.
  • Support cross-functional coordination to support high quality, timely, and compliant delivery of benefit-risk assessment for periodic safety reports (e.g., DSURs, PSURs) and support Safety Sciences Strategy in contributing Medical and Safety perspective to the GPS portfolio of documents (e.g., ARM, RMP, SMP) where required.
  • Drive development and implementation of relevant training programs for GPS staff, including maintenance of a standardized Safety Sciences training curriculum, proficiency matrix, and knowledge management repository across both Strategy and Delivery.
  • Serve as main point of contact to liaise with Safety Sciences Strategy Rare Disease GPS Leads.
  • Collaborate with key Regeneron interfaces (e.g., Clinical, Regulatory, Med Affairs, Biostats & Data Management).
  • Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines.
  • Implement talent strategy and leadership development initiatives that raise capabilities across the organization.

This Role Requires:

  • Advanced Degree required in life sciences or healthcare with 12+ years of PV experience, preferably with a focus on Safety Sciences and Rare Disease experience.
  • Strong attention to detail with the ability to assess and optimize Safety operations processes, drive consistency, and ensure high-quality, compliant execution across activities.
  • Strong leadership capabilities and presence, interpersonal, verbal and written communication skills, organizational and workload planning skills along with the ability to manage multiple different projects simultaneously.
  • Preferred experience with oversight of operations within a global patient safety organization.
  • Preferred experience with AI technologies.
  • Preferred experience leading a matrixed role working across multiple areas of an organization and people management.

Director, Global Patient Safety Sciences Delivery - Rare Disease employer: BioSpace

At Regeneron, we pride ourselves on fostering a collaborative and innovative work environment that empowers our employees to make a meaningful impact in the field of biostatistics and beyond. Located in Tarrytown, NY, Cambridge, MA, or Warren, NJ, our culture promotes professional growth through mentorship and continuous learning, while offering a competitive benefits package that includes health and wellness programs, retirement plans, and generous paid time off. Join us in our mission to develop life-changing medicines and be part of a team that values diversity, creativity, and excellence.

B

Contact Details:

BioSpace Recruitment Team

StudySmarter Expert Advice🤫

We think this is how you could land Director, Global Patient Safety Sciences Delivery - Rare Disease

Unlock Networking Opportunities

Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like BioSpace. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.

Join Relevant Professional Bodies

Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like BioSpace.

Leverage Internships for Full-time Roles

If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like BioSpace. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.

Tailor Your Approach

When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what BioSpace is looking for. A tailored application can really make you stand out!

We think you need these skills to ace Director, Global Patient Safety Sciences Delivery - Rare Disease

Safety Data Processing
Submission Creation
Documentation Accuracy
Safety Surveillance
Signal Management
Aggregate Reporting
Compliance Management

Some tips for your application 🫡

Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at BioSpace!

Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show BioSpace that you're not just a fit for the job but also a safety-conscious candidate!

Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at BioSpace!

Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At BioSpace, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.

How to prepare for a job interview at BioSpace

Understand the Science

Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at BioSpace that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.

Showcase Relevant Experience

If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.

Know Their Products

Take some time to familiarise yourself with BioSpace’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.

Be Ready for Regulatory Scenarios

In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.