Recent project include:• Project Manager for an Innovate UK funded project (iMATCH) intended to increase patient access to Advanced Therapy Medicinal Products in the Manchester regions. Based at the Christie Hospital, this role involved project set-up and reporting and co-ordination of 12 academic, clinical and commercial partners as well as liaison with other Advanced Therapy Treatment Centres (ATTC) in the UK (Jan18-Jul18).• Clinical Delivery Director for a UK biotech with an innovative portfolio of first-in-class treatments that target multiple mechanisms of the most aggressive forms of cancer. This role involved the design and set-up of a ‘modular-design’ first-time in man clinical study with an oral CDK7 inhibitor (Jan17-Dec17).• Clinical Project Director for Aptus Clinical, a full service CRO specialising on early phase oncology, advanced therapies and rare diseases. This role has involved consultancy, business development, key-account and project management activities (Jan 16-current).

Currently leading the global clinical transfer of an oncology divestment project and leading the Clinical Submission Team for a regulatory submission of cediranib in advanced ovarian cancer.In my role as a Clinical Delivery Director I have been accountable for operational input into the global clinical development plans and the operational delivery of all clinical studies (Phase I-IV). I have gained experience across all phases of development from study design, delivery mechanism selection, feasibility and study set up through to final study study reporting. I have led the delivery of Phase III oncology programmes to submission and regulatory approval (in-house and outsourced delivery models) ensuring cost effectiveness, quality and delivery of business critical data to plan. I also have experience of leading led Phase IV and life-cycle magement (LCM) components of approved medicines in oncology.

Led global early phase (Phase I-IIa) multi-disciplinary teams (including CROs) to develop and deliver early Clinical Development Plans and biomarker strategies in oncology patients and healthy volunteers. Delivered global Regulatory Clinical Pharmacology packages e.g. single / multiple ascending dose studies, mass-balance studies, bioequivalence, DDI pharmacology studies for labeling purposes including special patient populations (e.g. renal and hepatic impairment). Accountable for the resource and budget requirements, risk management and defining go/no go criteria to deliver the projects to time cost and quality. Gained experience of clinical pharmacology requirements to suport NDA, sNDA and life cycle management in a range of indications(cardiovascular, oncology and infection).

Leadership of cross functional teams to deliver programmes of studies within a drug project to cost, quality and time. Experience in oncology, CV, CNS and infection indications working globally across Asia, EU and Americas.

Responsible for global cross functional leadership of an individual studies to cost, quality and budget. Accountability for the set up, monitoring and closure of global clinical trial investigator sites to ensure quality of clinical trial data and study conduct to GCP requirements.

Responsible for Investigator site, CRO compliance and document audits. Gained experience of GCP requirements via Regulatory Inspections.

Utilised a variety of molecular biological techniques to investigate the relationship between genetically acquired antibiotic resistance and expression in hospital acquired infections.