Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients' lives.

Summary of the Position:

We are looking for a Pharmacologist to join our Pharmacologist department. This role can be either hybrid working or fully remote in the UK/EU.

You will provide support for the Clinical Pharmacology aspects for clinical and consultancy projects at Simbec-Orion to ensure they are designed, executed and delivered to meet clients' development needs.

You will work closely with Medical and Project Management departments to provide design aspects of Clinical Pharmacology studies during protocol development including review of all available non-clinical and clinical data to ensure the study design meets applicable regulatory guidelines. Also you will also provide scientific oversight during the conduct of the study, will lead on any non-compartmental pharmacokinetic analysis associated with the study, will lead on the interpretation of the results and the writing of pharmacokinetic reports.

Key Accountabilities:

• Support in the assessment and/or development of study protocols, advising on the Clinical Pharmacology aspects of projects Across the Clinical Pharmacology Unit.
• Perform pharmacokinetic analysis for Simbec-Orion clients on both clinical trials performed by Simbec-Orion and analyses provided as a stand-alone service.
• Interpret pharmacokinetic data and write stand-alone pharmacokinetic reports/the pharmacokinetic section of clinical study reports.
• Support engagement of hospital specialists, GPs, consultants, and other healthcare/academic professionals to grow the NHS and academic collaborators' network and increase the Clinical Pharmacology Unit's capacity to recruit suitable volunteers and patients for clinical trials.
• Support in Commercial Development activities for early phase development opportunities, including attending prospective client meetings, responses to RFIs/RFPs, bid defence meetings.

Minimum Requirements:

Essential:

• MSc Life Sciences
• Previous direct operational involvement in design, conduct and management of a significant number and variety of commercial trials
• Experience in reviewing non-clinical data
• Excellent decision-making skills
• Well organised and able to cope with a significant workload and changing priorities
• Excellent verbal and written skills, with the ability to tailor communication to a variety of internal and external stakeholders
• Proficient with MS Office suite
• Experience in non-compartmental pharmacokinetic modelling using WinNonLin software (or similar)

Desirable:

• PhD in Life Sciences
• Post-graduate Certificate in Human Pharmacology or equivalent
• Experience in supporting commercial development activities, including attending initial client meetings responding to RFIs/RFPs, attendance at bid defence meetings
• Experience in providing drug development consultancy (focussed on pharmacology and/or strategic regulatory aspects) to the biotech/pharma sector
• Experience of collaborative interactions with the NHS/academic clinical research community
• Experience in Pharmacokinetic simulation and/or compartmental pharmacokinetic modelling using WinNonLin software (or similar) for a range of routes of administration and study designs
• Experience in interpreting pharmacokinetic data and writing stand-alone pharmacokinetic reports/pharmacokinetic sections of clinical study reports

Simbec-Orion Job Profile - Pharmacologist.docx


Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.