Legal and Regulatory Associate – Legal Counsel - GeneVault Lifesciences Inc. - USA
(2025-09)
Consultant providing executive-level legal counsel across global clinical data, research, and technology operations.
- Provide executive-level legal counsel across global clinical data, research, and technology operations, ensuring compliance with multi-jurisdictional regulatory frameworks (including GDPR, HIPAA, and international clinical research standards).
- Lead the development and execution of global legal and regulatory strategy, advising senior leadership on complex compliance issues, market entry considerations, and emerging regulatory risks.
- Oversee enterprise-wide legal risk management, including identification, assessment, prioritisation, and mitigation of legal and regulatory risks across data governance, clinical partnerships, commercial agreements, and product development.
- Direct the negotiation, drafting, and management of high-value and high-risk contracts, including strategic partnerships, data licensing arrangements, clinical research agreements, and global vendor contracts.
- Define and govern internal legal and regulatory policies, SOPs, and compliance frameworks; lead targeted training programs to strengthen organisational compliance culture and operational resilience.
- Serve as a senior liaison with regulators, external counsel, and key global stakeholders, representing the organisation in discussions and industry forums.
- Collaborate closely with executive, scientific, data, security, and commercial teams to integrate legal considerations into corporate strategy, innovation planning, and operational execution.
Interim Contracts Manager - The Institute of Cancer Research - London
(2024-05 - 2024-12)
Consultant providing senior legal risk advice and contract management.
- Senior legal risk advisor for contracts (incl. vendor, clinical and regulatory agreements)
- Contractual and financial reviewer and approver.
- Legal risk mitigation advisor specifically addressing IP, governance, GDPR data protection, indemnities and insurance.
- Lead high profiled, high budgeted projects.
- Support Head of Contracts and Head of Legal on all matters concerning ICR and it's obligations/liabilities.
SENIOR ANALYST, Global Business Strategy and Operations - Jazz Pharmaceuticals - London
(2023-02 - 2024-02)
Consultant managing procurement and contracting operations.
- Manage Procurement and Contracting management within EU and US.
- Provide procedural and contractual advice to improve process and deliverables.
- End to end vendor management
- SAP management – Creation of budget, purchase orders (change orders as required).
- Ensure Contracts are held at the highest standard, mitigating legal and financial risk.
- Analyse data and ensure projections meet companywide objectives.
- Provide support to Senior Director.
- Act as leadership with S2P project transition.
- Point of contact for complex and escalated matters concerning contracts and finance.
- Review SOPs, processes and systems and provide analytical advice to Senior Director.
RESEARCH CONTRACT MANAGEMENT - University of Birmingham - London
(2022-09 - 2023-02)
Consultant managing research contracts.
- Draft, negotiate and manage contracts including SLAs, Vendor Agreements, NDAs, Site Agreements, Collaboration Agreements etc.
- Fee for services agreement creation, vendor agreements and clinical contracts creation and negotiation.
- Legal review, drafting and negating with various stakeholders.
- Project review in line with contractual requirements – advisory support to leads, department and senior management.
MANAGER, SITE CONTRACT MANAGEMENT - Precision for Medicine LLC - London
(2021-10 - 2022-04)
Consultant managing site contract operations.
- Supports process and procedures development/improvement for EU site contract management in the organization in alignment with global processes etc.
- Project manage CTA kick off meeting with input from legal for CTA language negotiation and PM/CTM for site budget negotiation.
- Vendor contract and account management including contract and budget creation.
- SAP management – Creating purchase orders in-line with master budgets.
- Review, draft and negotiate a variety of agreements including site contract agreements including confidentiality agreements, investigator and institution agreements, ancillary agreements, equipment loan agreement, National Coordinator agreements, and other site contracts following provision of templates from legal.
- Resolve CTA language issues according to agreed site contracting plan and escalate complex issues with legal team.
- End to end clinical contracts management.
- Negotiate site budget (directly with site of via CRA) escalating out of range parameters to CTM/PM/Sponsor.
- Initiate negotiated CTA QC with review from legal and CRA (if required).
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant leadership and business teams regarding the status of contract negotiations and execution.
- Establish, track, report and manage contract metrics.
- Coordinate execution of site agreements and track agreement expirations and other obligations.
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Other tasks, as assigned.
Interim Research Contract's Manager - St. George's - London
(2021-03 - 2021-08)
Consultant providing legal advice and contract management for clinical research.
- Provide legal advice in relation to clinical research projects including global Covid-19 studies.
- Draft, negotiate and manage contracts including SLAs, Vendor Agreements, NDAs, Site Agreements, Collaboration Agreements etc.
- Support JRES department across three divisions for their respective contracts and legal documents.
Ass. Secretary General - COEJ - London
(2021-10 - 2024-10)
- Be responsible for supervising and managing CoEJ office staff.
- Prepare an annual report on the activities of CoEJ and present at the annual Conference. He shall also present any reports that are required for discharging any responsibilities CoEJ may have and in compliance with any legal obligations.
- Be responsible for giving notices of all meetings and Conferences (which shall also be placed on the CoEJ website).
- Prepare the agenda of all meetings and Conferences in consultation with the President (which shall also be placed on the CoEJ website).
- Record, maintain and distribute full and proper minutes of all meetings and Conferences. After the minutes of the Executive Council have been approved by the Executive Council, the Executive Council shall authorise the publication of those minutes subject to any redaction that it considers necessary. The minutes of Conference shall be approved at the next Conference.
- Deal with all correspondence in accordance with the direction of the Executive Council, Conference or President, whichever is applicable.
- Maintain and regularly update a register of Members and their voting rights.
Sr. Contract Lead - Bristol Myers Squibb - London
(2019-08 - 2021-02)
- Manage contracts across northern Europe including U.K., Ireland, Belgium & Netherlands.
- Lead on contracts for Investigator Sponsored Research (ISRs) across countries.
- Provide Legal and financial advice in relation to clinical research.
- Advise on GCO and ISR contractual language and best practices.
- Protocol review and budget analysis in line with global funds
- Creation of funds and vendors.
- Use of Eclipse, Ariba, Viva, Gateway and SharePoint systems.
- First global site and first global patient recruited for a global cardiovascular study.
- Mentoring and guidance for DACH hub for ISR (FMV Assessments).
Contract Specialist III - Medpace LLC - Mansion House, London
(2019-03 - 2019-08)
- Manage the Contract process for Clinical Trials in the U.K. and Ireland. Ensuring the financial and legal provisions are maintained.
- Budget analysis and review for projects with multisite set-up (13 sites +). Lead on all contractual matters with specific focus on Sponsor's requirements.
- Advise Sponsors on U.K. specific requirements considering timelines and contract execution projections for all sites.
- Provide this institution insight on NHS legal frameworks, governance and financial set ups. Advise on best approaches to reduce time and increase adherence to projected timelines.
- Attend and contribute to Sponsor/Site meetings and advise on all contractual matters arising from Study formation.
Legal Specialist (Research/Contracts) - Imperial College Healthcare NHS Trust - London
(2018-01 - 2019-03)
- Manage, Draft, review and negotiate various types of research and research-related contracts such as: Model agreements, Bespoke Clinical Trial Agreements, Confidentiality Agreements, Novation Agreements, Master CDAs/CTAs, Compassionate Use Agreements. I.P. Agreements.
- Providing Excellent working knowledge of legal matters and issuing legal advice
