(Senior) Director, EU & UK Compliance Counsel

About Autolus

Autolus is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defence mechanisms, and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases.

Why Autolus?

Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and autoimmune diseases to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership and teamwork. In addition to this Autolus is proud to offer a competitive salary, performance related bonus as well as a comprehensive benefits package.

Our Promise

Autolus is developing complex, breakthrough therapies for a globally diverse market and equally recognises that diversity amongst our people is critical to our mission. As we draw on our differences, what we’ve experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees.

Role Summary

The (Senior )Director, UK & EU Compliance Counsel is responsible for developing, implementing, and managing the organization’s EU and UK compliance and privacy programs and providing legal advice to support compliance with applicable laws, regulations, industry codes, and company policies. This role oversees matters relevant to the biopharmaceutical industry, including GDPR, UK GDPR, EMA and MHRA requirements, and the ABPI, EFPIA, and IFPMA codes, and serves as a key point of contact for UK and EU personnel on compliance and privacy matters.

The ( Senior )Director will support the Vice President, Compliance and the wider legal team by providing practical legal and compliance advice. The role partners with senior leaders and cross-functional stakeholders to develop policies, deliver training, review and approval of promotional and medical materials, and will provide legal support for contract drafting, review, and negotiation, as well as other legal matters that arise from time to time.

Key Responsibilities

• Support internal reviews and investigations relating to compliance incidents, concerns, or potential breaches.
• Develop and implement corrective action plans to address compliance issues.
• Maintain documentation of all compliance activities and investigations.
• Collaborate with department heads to promote a culture of compliance.
• Provide guidance and support to senior stakeholders on compliance-related matters.
• Develop, implement, and maintain comprehensive UK and EU compliance programs and policies.
• Monitor and advise on applicable EU and UK laws, regulations, and industry codes, and support implementation of controls to maintain compliance.
• Advise on EU and UK data privacy requirements and develop policies and procedures to support compliance, including DPIAs and DSARs.
• Conduct regular compliance risk assessments and audits to identify potential areas of vulnerability in line with cell therapy development and commercialization.
• Support review of promotional and medical materials through Veeva PromoMats to ensure compliance with applicable legal, regulatory, and company requirements.
• Prepare and submit required compliance reporting, including transparency reporting, in accordance with applicable legal and regulatory requirements.
• Support the team to develop and conduct compliance training programs for employees at all levels.
• Ensure all staff are informed of their responsibilities under the compliance program.
• Provide ongoing education and resources to keep the organization current on compliance best practices.
• Provide legal support in the form of drafting, reviewing, and negotiating agreements with Healthcare Providers, Healthcare Organizations, and other external parties as needed.
• Ensure that all contracts contain required compliance and privacy terms (e.g., terms related to transparency reporting and/or Data Processing Addendums).
• Provide practical legal support on commercial and operational matters within the scope of the role.

Demonstrated skills and competencies

E – Essential P – Preferred

Experience

• Significant progressive experience in compliance and ethics within the life sciences industry, typically gained over 5–10 years (P)
• Legal qualifications in the UK or the EU (E)
• Experience implementing GDPR requirements (E)
• Experience negotiating DPAs (E)
• Experience with cell or gene therapy compliance issues (P)

Qualifications

• Bachelor’s degree or equivalent (E)
• Legal experience or qualifications in the UK or the EU(P).

Skills/Specialist knowledge

• Experience developing and implementing effective compliance programs in the life sciences industry (E)
• Knowledge of compliance regulations in one or more European jurisdictions where the Company operates (currently the UK, Germany & Switzerland) (P)
• Understanding of the pharmaceutical industry with expertise in applicable laws and regulations (E)
• Experience drafting, reviewing, and negotiating contracts (E)
• Ability to work effectively with a variety of stakeholders, both internal and external (E)
• Excellent interpersonal, oral & written communication skills; experience writing and presenting to diverse audiences(E)
• Ability to influence behaviour, and proactively identify potential problems (E)
• Be business oriented and solution-driven (E)
• Willingness to move at a fast pace and drive efficiencies (E)
• Proficiency with Veeva Promomats, MS Office and with common remote work tools, including videoconferencing, Sharepoint, and other cloud-based services (E)

Autolus is committed to the protection of the personal information that we collect & process and we are fully compliant with General Data Protection Regulations (GDPR).

Autolus is committed to providing an inclusive and fair workplace for all. We are an equal opportunity employer and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We also provide reasonable accommodations throughout the recruitment process.

Autolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard. Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.