Bringing project management expertise to a range of drug development programs and continuous improvement projects.

Contract specialty pharma global project management role, supporting both pre- and post-approval assets.This includes successful project delivery whilst working across a range of outsourced partners and contractors - tying individual project plans into an overall delivery program and reporting progress to c-suite personnel.

A leadership role, responsible for the management and successful completion of scientific and technical R&D projects and programmes within Midatech as well as setting up and driving project management processes within the company.Project manager for Midatech’s phase I glioblastoma therapy. Coordinating clinical, regulatory, CMC, and commercial preparations for a complex orphan drug project, including an innovative clinical pathway.Project director for a number of early-stage oncology therapies. These projects include controlled release local therapies and immediate release infusions. My role requires the ability to rapidly assess new technologies and disease areas in order to build project plans mapping progress from initiation through to phase I.

Syneos (initial employment via Kinapse) is recognised as a leading advisory and operational services provider to the global Life Sciences industry. The company provides its services across the full R&D and commercialization life-cycle, collaborating with its clients to improve the lives of patients, through a unique Advise – Build – Operate delivery model.I had a leadership role within a team of program managers, responsible for embedding world leading project management methodologies into the Kinapse/Syneos organisation.Successes include:Program management and continuous improvement responsibility for a £2M+ full service regulatory program. This program supported the post approval activities for a £2Bn product portfolio, and represented a key account for Kinapse. Over the course of five years, I have delivered significant productivity improvements, whilst also finding efficiency savings and exceeding all service targets.Program director responsibility for pharmacovigilance and medical writing support for a niche portfolio with a top five pharma company. This program consistently met all service measures since kick-off in 2015.Several successful consultancy projects, helping clients roll out new systems & deliver strategic initiatives.Leadership of several company training days, focusing on company-wide team building and skill enhancement.Project management support for RFI/RFP & bid defence activities, resulting in multiple wins of new programs from top five pharma companies. One such bid required my management of a 300 page professionally finished bid document, authoring of bid content, attendance at bid defence meetings, and management of a subsequent ‘bid readiness’ program.

Responsible for the development of a new IXRS to support incoming clinical trials. Including recruitment of new staff and management of a cross-departmental team. A significant proportion of company revenue relied on the success of this project, and I reported directly to the COO.Responsible for leading the integration and ongoing management of multiple software systems across twenty clinical trials; supporting the needs of data management, clinical project management, site management, and regulatory activities.Involved in bid defence and budget preparation for new activities. This involved reviewing approximately 50 protocols per year, and required an understanding of phase II and phase III clinical design and interaction with other company departments, such as regulatory and pharmacovigilance.

Providing freelance project management and project support expertise to Biotech and Pharma companies in the UK. Specialising in project planning, resource forecasting, risk identification and management, clinical supplies management and due diligence preparation.Managed preparations for a MHRA inspection, coordinating the efforts of seven departments, forty people, and teams in both the UK and the USA. Preparations resulted in a successful audit with no critical or major findings.

Provided planning support for pharmaceutical projects. Acknowledged by partner and contractor organisations for giving clarity to complex projects. Project size ranged from £5-25M with cost savings directly attributable to my role of £50-250K per project.Led the development of the project management office (PMO) at Vectura Nottingham, harmonizing project management processes and demonstrating the benefit of PMO support. Site housed 120 staff, with my role being integral to drug development projects, and often leading teams for specific initiatives.Comfortable presenting and discussing data, timelines, costs and scenarios with senior board members. This required a thorough understanding of the individual project activities and the ability to justify contingency planning and highlight acceptable risks.Led the preparation of due diligence packages for the sale of a number of multimillion pound projects. This included management of all project related documentation, generating budget slide decks, and resulted in a licensing deal.Part of a project office team that developed project dashboards, and an Excel based resource forecast sheet for use across three sites and accounting for 150 people and 12 projects. This forecast was used to manage headcount, consider new activities, and if necessary recommend project freeze.

Successful management of a small team, completing specific work packages to fixed deadlines, often in collaboration with partner companies such as Bristol-Myers Squibb.Took a leading role in an inhaled insulin project, including method development and technology transfer to a contract manufacture organisation. Provided expertise resulting in patented technology.

Analytical support for novel molecules and devices. Responsible for activities essential to the release of a new asthma treatment (now a marketed product).Participated in a successful audit by the Food and Drug Administration. Received 3M Achievement Award for consistently meeting project deadlines.

Internal and external client point-of-contact, providing customer technical support across the full range of analyses provided by the Agency. Received a written commendation from the midlands area manager.

Improved all aspects of Loughborough Students rowing club. Including coaching, sponsorship, facilities and long-term planning.