Chief of Biotherapeutics and Advanced Treatment Solutions

3 weeks ago

London, Greater London, United Kingdom Medicines and Healthcare Products Regulatory Agency Full time

Position Overview

The Medicines and Healthcare Products Regulatory Agency is seeking a Director of Biotherapeutics & Advanced Therapeutic Strategies to become a vital part of our Research & Development division within the Science, Research & Innovation sector.

This role is a full-time position, available on a fixed-term contract/internal transition or temporary elevation basis. The successful candidate will be expected to operate within the UK, as this role is not available for remote work from overseas.

Government initiatives are currently promoting a minimum of 60% in-office attendance.

We are adopting a flexible, hybrid working model, requiring a minimum of 8 days per month on-site to foster collaboration and engagement with partners and stakeholders essential for fulfilling our regulatory responsibilities. Depending on business requirements, this on-site commitment may increase to 12 days monthly, with the remaining time being allocated for remote or office work. Certain positions may necessitate more frequent on-site presence.

About Us

The Medicines and Healthcare Products Regulatory Agency plays a crucial role in enhancing public health through the effective oversight of medicines and medical devices, driven by scientific principles and research.

The Science, Research and Innovation Group is dedicated to achieving significant public health outcomes through pioneering research and innovation, guided by an ambitious Science Strategy that balances innovation with sustainability and cost-effectiveness. This group is divided into six sub-sections: Innovation Accelerator, Clinical Investigations and Trials, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance, and Health & Safety.

The Research & Development division is focused on creating biological reference materials and assays within regulatory sciences, alongside R&D efforts in key areas of national and international importance for current and future biological medicines, innovative therapies, diagnostics, and vaccines.

Role Responsibilities

The successful candidate will provide strategic scientific leadership and oversee a team of expert scientists dedicated to addressing critical regulatory scientific inquiries in the fields of Biotherapeutics and Advanced Therapies. This encompasses Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies, monoclonal antibodies, and immunotherapies. The role will also manage Research and Development initiatives and influence the creation of new physical standards and reference materials that support these significant products.

Key Duties:

  • Design and lead a globally recognized R&D program that tackles essential regulatory scientific questions related to Biotherapeutics and Advanced Therapies, particularly focusing on Cell and Gene Therapies, immunotherapies, and monoclonal antibodies. This program should yield impactful scientific data that benefits patients, supports the standardization of novel therapies, is suitable for publication in reputable scientific journals, and attracts ongoing external funding.
  • Work collaboratively with colleagues in the Standards Lifecycle and Control Testing Functions of SR&I to provide expert scientific guidance and practical assistance for the timely production of physical standards and optimal control testing for Biotherapeutics and Advanced Therapies, as necessary.
  • Act as an external representative of the Agency, providing expert insights into the regulation and control of Biotherapeutics and Advanced Therapies, offering cutting-edge guidance to senior colleagues and external organizations, including UK healthcare entities, the World Health Organization (WHO), global pharmacopeia, EDQM, industry stakeholders, and academic institutions; leading national and international collaborative initiatives.
  • As a key member of the R&D Senior Leadership Team, collaborate closely with expert colleagues across all groups to deliver specialized scientific advice regarding products in the biotherapeutics and advanced therapies sector.

Candidate Profile

The ideal candidate will possess:

  • A degree in Biomedical Science or a related field, complemented by extensive post-doctoral experience.
  • Internationally recognized expertise and a proven track record in Biotherapeutics and/or Advanced Therapies, with demonstrated success in securing resources and managing scientific projects effectively.
  • In-depth knowledge of practical aspects related to biotherapeutics and/or advanced therapies products, including cell and molecular biology, genetics, genomics, and biological medicines standardization.
  • Familiarity with the UK and European regulatory frameworks as they pertain to biological medicines.
  • The capability to adopt a strategic approach in identifying the organization's capability needs, along with the experience to foster a culture of continuous learning and knowledge sharing.

If you are interested in exploring this exceptional opportunity, we encourage you to review the full job description.

Benefits

In addition to a competitive salary, the Medicines and Healthcare Products Regulatory Agency offers a comprehensive benefits package, including:

  • Annual Leave: 25 days of annual leave upon entry, increasing by one day for each completed year of service, up to a maximum of 30 days, plus 8 bank holidays.
  • Privilege Leave: 1 additional day.
  • Working Hours: 37 hours per week for full-time staff, with pro-rata adjustments for part-time employees.
  • Occupational Sick Pay: One month of full pay and one month of half pay upon entry, increasing by one month for each completed year of service, up to a maximum of five months of full pay and five months of half pay.
  • Mobility: A mobility clause in contracts allows staff to work across the Civil Service.
  • Flexible working arrangements to promote a healthy work-life balance.
  • Interest-free loans for season tickets or bicycles.
  • Access to Employee Assistance Services and the Civil Service Benevolent Fund.
  • Eligibility to join the Civil Service Motoring Association (CSMA).
  • A variety of staff and Civil Service clubs.
  • Ongoing learning and development opportunities.

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