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Trial Clinical Pharmacologist
3 months ago
The Company
BioPharma Services Inc. is a subsidiary of Think Research.
BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients.
Through each success, and even some failures, the perpetual drive to make BioPharma great has been determined by the will and dedication of our people.
The will to empower their colleagues, friends and teammates to excel in all facets of clinical research and inspire performance to achieve greatness.
It is with this same culture and brand of excellence that we welcome our clients.To experience the team community that has propelled us into a global leader in medical research, to be a client-focused partner, where people and patients matter.
Again, we invite you to come and meet our people. Our people who have learned that success is better achieved and celebrated as a team than as an individual.Why Us?
- It's not every day that you have the chance to change the way your friends and family are cared for
- Make an impact
- Everything we do and we do it with passion is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.
- We're growing, and so will you with leaders who will support your development through mentorship and other opportunities
- Collaborative, creative, dynamic and flexible work environment, with a startup spirit
The Role
This position is a full-time, contracted position.
It required TCP to work and report directly to a large international pharmaceutical company on Phase I, II, and III studies.
You Will Have The Opportunity To:
- Support clinical study execution by performing necessary tasks such as contribution to documents (e.g., Trial Statistical Analysis Plan, Case Report Form and Analysis Dataset Specification document) and participation in trial team meetings (Trial Oversight Meeting, Blinded Report Planning Meeting, Medical Quality Review Meeting and Results Alignment Meetings, etc).
- Support the manager/supervisor in the generation of submission summary documents (e.g. Summary of Biopharmaceutic Studies and Associated Analytical Methods or Summary of Clinical Pharmacology) or pooled analysis reports as per the project needs.
- Steer exploratory and final noncompartmental analysis of PK/PD data and overview the generation of graphs and tables from the results and present/communicate the results to the trial team and/or project teams as appropriate.
- Develop processes and scientific knowledge as regards clinical pharmacology aspects of clinical trials. Contribute to national and global harmonization within the Clinical Pharmacology (CP) and Data Science groups (e.g. descriptive analysis team).
- Present study protocols and results in meetings of Clinical Pharmacology group, Translational Medicine, and Clinical Pharmacology (TMCP) department as well as trial/project specific meetings such as trial team meetings, project teams meetings, medical sub team and Drug & Device team meetings, etc.
- Present at panel and/or committee meetings (e.g., Clinical Expert Committe, Development Committee), external meetings (e.g., investigator meeting). Represent other TMCP functions like descriptive analysis team or Data concepts and services team for CP aspects in the trial team.
- Interact closely with other groups in the department of TMCP (e.g. Biomarker Integrators, Translational or TMCP Leads, Biomarker Platform, Data Science Leads). Depending on the study, TCPs also interacts with other groups and departments (e.g. Biostatistics and Data Sciences, Clinical Operations, Pharmaceutical Development, DMPK etc.) and with CROs (outsourcing).
- Contribute to scientific posters and publications.
What You Will Bring:
- M.Sc (or equivalent) in Medicine, Pharmaceutics, Clinical Pharmacology or equivalent area.
- Expertise in the fields of Clinical PK/PD with a minimum of 26 years relevant in the pharmaceutical industry, regulatory agencies, or academia.
- Knowledgeable in clinical PK/PD, biopharmaceutics, and relevant regulatory guidelines.
- Proficiency in graphic software packages.
- Proven abilities in understanding and interpretation of statistical output.
- Good presentation and teamwork skills.
- Strongly independent and diligent.
- Think Research and all subsidiaries are proud to be an equal opportunity employer and is committed to creating a diverse and inclusive workplace, free of discrimination and harassment._
- We provide equal employment opportunities (EEO) to all employees and applicants regardless of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status._
- We are committed to providing accommodations for people with disabilities. Should you require an accommodation, we would like to work wi
