Reporting to and working with the Manager, Pharmacokinetics, the Scientific Leader, Pharmacokinetics is responsible for the management of work and supervising the operation of the Pharmacokinetics department. In this role, the incumbent interacts cross-functionally with other management members within the BioClinical Development Division to ensure that all biostudy projects and related work is properly planned and managed. The incumbent ensures that departmental administration and work is properly assigned and completed, and that all work is conducted in full compliance with established Apotex Inc. Policies, Standard Operating Procedures and relevant Regulatory Guidance(s). In addition, the Scientific Leader, Pharmacokinetics is working together with the Manager, Pharmacokinetics on recruitment, hiring and , coaching of the departmental staff, and is directly responsible for performance management of the relevant employees in the Pharmacokinetics Department.
Key Job Responsibilities
* Participate in the establishment of the strategy and workplan for the Pharmacokinetics department.
* Assign work to the appropriate personnel.
* Supervise the relevant scientific, technical, and administrative aspects of routine departmental work in the Pharmacokinetics department. .
* Reviews all biostudy related work that is completed by Pharmacokinetics staff.
* May review other work completed by departmental staff (protocol synopses, biowaivers).
* Recruit and hire personnel for the Pharmacokinetics department, in collaboration with the manager.
* Work directly with all appropriate staff to ensure the proper operation, maintenance and repair of all relevant departmental equipment.
* Monitors assigned project timelines. Take a leadership role in supporting the staff and ensuring the completion of assignments in conformance with BCD’s deadlines.
* Supervise and guide the development, testing, validation and implementation of computer software/programs necessary for the Pharmacokinetics department.
Relationship with Internal/External Customers/Stakeholders
* Develop and maintain strong relationship with all levels of personnel within BCD.
* Work constructively and proactively with others in the management group of BCD to promote the efficient and effective operations of the Division.
* Interact with other departments on scientific matters related to pharmacology and pharmacokinetics
* Use effective communication and interpersonal skills to support the work of Biostudy Project Teams
* Support and guide the collaboration of all Pharmacokinetics’ employees with Quality Assurance auditors during project audits and ensure the response to the audit observations is completed in a timely manner.
Problem Solving /Analysis
* Utilises advanced problem-solving techniques to identify root causes of operational problems/issues.
* Recommends unconventional problem solving techniques to peers and the next level of management.
* Utilises advanced problem-solving techniques in collaboration with others at BCD in the development of new processes and procedures for the Division.
* Take a lead role in the development and updating and/or otherwise direct the maintenance of departmental and Divisional SOPs and non-SOP procedures.
* Develop and/or recommend the adoption of new policies and procedures for the improvement of efficiency and effectiveness of the Pharmacokinetics Department.
Leadership/Professional Development of Self & Others
* Manage the relevant personnel of the Pharmacokinetics Department in accordance with corporate policies.
* Provides routine/informal performance feedback to the relevant staff, as required, and conducts formal performance appraisals of assigned staff.
* Provide direction / support for the development and management of relevant staff training.
* Coach Pharmacokinetics Department staff in development of their competencies, develop constructive action plans to address staff performance gaps, follow up on progress and provide feedback.
* Identify gaps and improve performance issues of staff, when required. Investigates, brings to the attention of the Manager, Pharmacokinetics and collaborate in reaching the solution in complex problems arising in the department.
* Interact with other divisional management staff as required to support the efficient and effective operation of the Division
Compliance & Due Diligence
* Ensures that all work and procedures are conducted in compliance with SOPs and relevant regulations
* Proven leadership and management skills.
* Advanced problem solving, decision-making and analytical skills.
* Conflict management capability.
* Expert knowledge and understanding of pharmacokinetics and pharmacology
* Good knowledge and understanding of biopharmaceutics.
* Excellent, in-depth understanding of regulatory requirements in conducting bioequivalence studies.
* Good understanding and command of basic statistical principles and procedures
* Strong computer skills.
* A proven independent time management and project management capability
Educational Requirements / Experience:
* M.Sc. or Ph.D. in Pharmacokinetics /pharmacology/ Pharmacy / Pharmaceutical Sciences
* 2 years experience in supervising high-level scientific personnel
* At least 3 years of experience in the area of bioequivalence and pharmacokinetics.
* At least 2 years of industry experience in developing protocols and preparing reports for regulatory submissions.
* Previous experience in design of clinical trials and interpretation of the results is an asset. Apotex - 2 years ago