Programme Manager - Metabolism - Rushden, Northamptonshire
Programme Manager - Metabolism
Based at Rushden, Northants
Pharmaron is a premier R&D service provider supporting the life science industry. Founded in 2003, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development, including applications of 14C microtracer AMS technology. With operations in China, US and UK staffed by over 4,500 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.
The Rushden site is the a centre of excellence for Radiolabelled Sciences incorporating both Metabolism (which includes Clinical Metabolism, Pre-clinical ADME, In vitro and DDI services, Large Molecule Metabolism, Environmental Fate and Plant Metabolism and Metabolite Identification) and Chemistry (which includes API and IMP manufacture).
Due to recent expansion Pharmaron are currently looking to recruit a Programme Manager at their Rushden facility within Metabolism.
- To design, conduct and report on clinical metabolite profiling and identification studies.
- Manage programmes of studies for a client which extend across different Metabolism areas e.g. ADME, Clinical QRA, Metabolite ID & profiling, In Vitro & DDI and involve external organisations e.g. Clinics and Subcontractors.
- Work closely with operations for the scheduling of programmes and making sure they stay on track
- Ensure Sponsors are kept informed of study progress and there is good communication between different areas of Metabolism and external Organisations
- Act as Analytical Project Manager on clinical metabolite profiling and identification studies.
- Prepare analytical work plans, study reports and SOPs as required.
- Take full responsibility for the conduct of experimental work required to successfully fulfil all the requirements of a study to the timelines stated in the Study Plan.
- Work closely with clinical site and client to ensure requirements in terms of timelines are understood and can be met.
- Plan work to ensure revenue recognition milestones on assigned studies are hit in the month, flagging up any issues early. Ensure resource allocated to their studies is effectively utilised.
- Review data obtained and prepare study updates and study data for discussion internally and for communication to the client/inclusion into reports.
- Address findings arising from QA audits and process inspections.
- Act as a link person between Business Development and Operations at the proposal stage for packages that will require Programme Management support.
- Liaise with Business Development to raise supplementary proposals for scope changes/additional studies.
- Work with SDs/ the Metabolism management team to ensure all necessary pre-study information is obtained from the client and distributed.
- Maintain an overview of the "big picture" of assigned programmes of work to ensure client's overall objectives are being met, while also keeping sight of the detail of the individual projects.
- Mentor Associate Programme Managers as required
- Monitor and manage individual project timelines, liaising with Clients and with Operations/QA, as required.
- Discuss any significant changes to agreed timelines with Operations and if necessary raise any issues with the Senior Programme Manager and escalate to the Director of Metabolism (particularly if they impact dosing or have financial implications).
- Communicate regularly with clients to ensure their expectations are understood, managed and met as appropriate.
- Actively participate in and where necessary lead client facility.
- PHD/Bsc in Chemistry, Biochemistry or related discipline.
- Experience of performing the role of SD/APM on Clinical and Pre-Clinical Metabolism studies.
- Deep knowledge of Metabolism and the drug development process
- Experience of Programme management/delivering projects to deadline
- Full clean UK driving license
- Must be able to work on own initiative
- Highly motivated and ability to multi task
- Diplomatic with strong interpersonal skills
- Good communicative skills (both written and verbal)
- Excellent attention to detail
- Flexible - able to work outside of normal hours when required
The position is full time and permanent. Hours of work are 37.5 per week Monday - Friday. Annual holiday entitlement is 23 days a year plus Bank Holidays. The company operates a contributory pension scheme, life assurance and a flexible benefits package.
To apply please send a CV and a covering letter by clicking on the 'Apply' button quoting: Programme Manager-MET