Clinical Research Physician

ProStrakan Pharmaceuticals is one of Europe’s fastest growing speciality pharmaceutical companies with operations across the globe. Our strong ambition is evident with recent successes including our impressive European growth rate of 21% and advances in the U.S with new product approvals.

Couple these recent successes with our acquisition by Kyowa Hakko Kirin and it guarantees a prosperous future. KHK is a Japanese Speciality Pharmaceutical company with a turnover in excess of $5 billion. KHK have an exciting pipeline of products in all stages of development.

ProStrakan is positively set to achieve our goal of becoming a globally recognised player.

The Clinical Research Physician is responsible for providing clinical input into the design, conduct and reporting of PSK/KHK clinical studies, and provides medical support for global drug safety and risk management activities. Other responsibilities include:

Clinical Development Programme Management

·         Working within Product Development teams to agree clinical programmes and study designs to meet safety and efficacy endpoints.

·         Develop product attributes, awareness of competitor landscape, regulatory needs and constraints.

·         Liase with Key Opinion Leaders for exert input.

·         Participate and present at advisory board meetings. .

Key Member of Clinical Study Team

·     Responsible and accountable for providing day-to-day medical oversight of PSK clinical studies. This includes optimal site/patient selection, patient safety, and scientific integrity.

·      Training and support for the CRO and Clinical Study Teams to ensure good  understanding of the disease, treatment pathways, complications and delivery systems.

·       Engage with the CRO and study staff to assist with patient recruitment tactics and work with the team to keep recruitment on-track.

·       Monitor and review study data on an ongoing basis.

Clinical data review, interpretation and presentation

·         Review and interpret study data, as part of quality control, and as part of clinical evaluation.

·         Provide medical opinion and insight on data.

·         Contribute to medical writing of study reports and aggregate reviews.

·         Take part in presenting data and conclusions to internal and external stakeholders.

Provide Medical Support to Global Drug Safety and Risk Management

·         Be the primary contact for medical review of safety reports in PV.

·         Provide medical interpretation of safety data.

·         Contribute to development of safety planning for studies, including Post Marketing authorisation studies and investigator sponsored studies.

·         Contribute to the design of Risk Management plans.

 Maintain Compliance

·         Within Clinical Development and Drug Safety teams ensure that relevant SOPs and external guidelines and practices are followed. 

The ideal candidate will have experience in a similar clinical research position. Educated with a medical degree and eligible to practice in the UK with knowledge of the pharmaceutical industry and regulatory processes is essential. Within this role there will be some travel so flexibility is required.

You will be rewarded with an excellent package. The position will be based at our head office in the beautiful Scottish Borders.