Principal Research Pharmacist

Principal Research Pharmacist

ICON

Paris, France

About the role

You will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognizes merit and has a high focus on quality. This environment encourages innovation, individuality and embraces people that want to be a part of it.

The Pharmacy Investigational Product Specialist will serve as a key contact point between the sponsor and the investigational site for Investigational Product Preparation Instructions (IPPI) training of studies with a complex IP preparation process. This role will focus on IPPI review and training/implementation of IP preparation steps for all compounds deemed requiring training plans. The Pharmacy Investigational Product Specialist will be the key internal and external interface to ensure overall IPPI adherence . He/she will contribute to continuous process improvement, training and mentoring for IPPI.

Your Profile:

The tasks undertaken are varied and can include:

• Play a key role in the safe, efficient and effective Investigational Product preparation and administration in clinical trials.
• Review and provide input on Investigational Product Preparation Instructions Site Investigational Product Procedures Manual, monitoring guidelines and all specific forms related to Investigational Product preparation and dosing before finalization as applicable.
• Process risk assessment review where applicable.
• Close collaboration with the Drug Product Development team and the Drug Preparation Administration Team.
• Collaboration on Investigational Product training material development with key stakeholders.
• Early connection with investigational site pharmacy and IP administration staff to review site IP process and equipment.
• Close collaboration with (Global Trial Lead) GTL, (Study Manager) SM, (Trial Manager) TM, Independent Drug Monitor (IDM) and Site Investigational Product Specialist (SIPS) for all IPPI related topics.
• Evaluate and support process for IP and ancillary supplies/preparation kits are compatible with the pharmacy equipment/practice in the country/investigational site.
• Review of site's preparation and accountability records to ensure key information is captured and documented.
• Observe first Investigational Product preparation on site and/or support SM/IDM/SIPS if allowed according to local guidelines and blinding requirements.
• Point of contact for the internal study team in the country for questions related to the Investigational Product preparation.
• Review any modification of IPPI, SIPPM manual, specific forms related to Investigational Product preparation and dosing during the applicable phases of the trial.
• Establish and maintain good and productive working relationships with internal and external stakeholders (e.g. pharmacists, investigators…).

Your Profile:

• A Pharmacy degree with focus on hospital practice, minimal 3-4 years of recent experience in a hospital or clinic required.
• Experience in antibody treatment (Oncology (hematology and solid tumor) and/or Immunology Therapeutic Area).
• Experience in preparing different drugs depending on the way of administration, especially intravenous, subcutaneous, and intramuscular.
• Experience in the (virtual) clinical trial setting.
• Minimum of 5+ years of recent clinical/hospital experience is required.
• Experience in preparation of novel pharmaceutical therapies such as gene-therapy or radiopharmaceuticals are an asset.