Senior Clinical Pharmacology Scientist

Position Summary:

The Senior Clinical Pharmacology Scientist will be the lead scientist providing scientific and regulatory oversight on projects from initial proposal to study design and protocol development, data analysis and clinical study report writing and review for human abuse potential and phase I - IV clinical trials. The Senior Clinical Pharmacology scientist will mentor and oversee junior members of the Clinical Pharmacology team. The Senior Clinical Pharmacology Scientist will work closely and efficiently with different internal departments during study development, conduct and study analysis and report writing. The Senior Clinical Pharmacology Scientist will be involved effectively in the scientific discussion with client. The Senior Clinical Pharmacology Scientist will assist Business Development with client interactions.

Duties and Responsibilities:

• Perform literature search and data evaluation to provide scientific support for assigned projects, including complex scientific projects
• Develop clinical study designs for Clinical Pharmacology studies including human abuse liability, and phase I - IV clinical trials
• The Senior Clinical Pharmacology scientist will mentor and oversee junior members of the Clinical Pharmacology team.
• Support Business Development (BD)/ Project Manager (PM) team and attend scientific discussion/meeting with clients and internal departments to develop study protocols for Clinical Pharmacology studies including human abuse liability, and phase I - IV clinical trial
• Develop expertise in areas of scientific and clinical priorities of the company
• Drive scientific and operational innovation at the site
• Write or oversee the writing of protocols and informed consent forms for Clinical Pharmacology studies including human abuse liability, and phase I - IV clinical trial
• Work closely and efficiently with PK, statistical, scientific, clinic personnel, the principal investigator to ensure the clinical study is conducted in-line with the protocol, regulatory guidance, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and other applicable guidance
• Work closely with Clinic/Pharmacokinetic personnel and the Principal Investigator, ensure that safety related issues are addressed in the timely manner to facilitate the clinical study protocol development and follow the standard required by GCP
• Provide scientific support to other departments throughout the whole clinical studies conduct from the beginning to the end
• Work closely with Pharmacokinetic/Stat/Data management team to evaluate the study data and results
• Work closely or contribute with report writers to write or review the relevant sections of the study report with regards to the study results
• Participate in developing/adjusting study strategies and ensuring compliance with project timelines
• Assist in the development of SOPs and guidelines linked with the department activities
• Assist with the preparation for Regulatory agencies and participate in any discussion with the inspectors, if it is needed
• Establish optimal timelines with external departments in order to meet study projects timelines
• Perform other activities within the Clinical Pharmacology department as needed
• Present at international scientific meetings, as appropriate
• Prepare abstracts, papers and manuscripts for publication or presentation

Qualifications:

• PhD in Pharmacology/Pharmacy or related field;
• Experience in the pharmaceutical industry or in a CRO is an asset;
• Strong scientific and regulatory knowledge background and working experience on the clinical development process including, but not limited, to phase I - IV clinical trial;
• Experience related to the abuse potential clinical trials is an asset;
• Proven abilities in literature evaluation, study design, scientific and medical writing and scientific support;
• Extensive experience writing all types of clinical documents and within the regulated environment, not limited to FDA, TPD, and EMA;
• Experience with current regulatory/ICH requirements on clinical study protocols and reports;
• Demonstrate analytical thinking with strong attention to details, good initiative, ability to work with changing priorities and effective time management;
• Excellent communication and interpersonal skills and ability for multitasking.