Clinical Operations Director
The Clinical Operations Director is a Medical Doctor with functions as a Clinical Research Lead: he has overall responsibilities for the optimal execution of clinical trials placed at the research unit, with emphasis on the oversight of medical aspects of all trials. He may act as Principal Investigator on a clinical trial as well as Manager of Clinical Research staff.
The Clinical Operations Director may also act as Site Head whenever appropriate (Associate Medical Director).
* Leads Clinical Project Managers and Principal Investigators in the Unit.
* Manages research and operational issues arising from ongoing clinical studies with timely identification and assessment, appropriate action and communication.
* Assures superior level of quality in study execution and povides input to protocol development and review; participates in committees/governance, as appropriate.
* Ensures that all studies are performed in compliance with existing SOPs, Good Clinical Practices, and all work instructions or guidances to guarantee the efficient and compliant medical operations of the PCRU.
* Exercises sound judgement on utilizing breadth of knowledge and prior work experience, so as to constitute a competent resource for colleagues in relevant areas.
* Ensures close collaboration with other functional groups within the unit, i.e. study planning; volunteer/patient recruitment; study conduct and study close out.
* Liaises with other Pfizer sites regarding the design, conduct and progression of Pfizer Phase 1 Clinical studies. Provides scientific/clinical support to early projects.
* Coaches and develops Clinical Project Managers and Principal Investigators, and gives inputs in the coaching and development of other clinical research staff.
* Represents the PCRU on company-wide initiatives in the area(s) of expertise, as assigned.
* May represent Pfizer in external environments (e.g., scientific meetings, advisory meetings, etc.) in the area(s) of expertise, as assigned.
* Develops, maintains and shares subject matter expertise on Clinical Research Unit SOPs, Clinical Pharmacology and/or Biomarker Methodology topics and studies.
* Ensures an appropriate knowledge/understanding of translational medicine and early clinical development of the clinical research staff.
* If serves as principal investigator, being accountable for medico-legal, human safety and medical governance aspects of assigned studies within the PCRU.
* Participates as instructor in different training courses for the clinical research staff as appropriate, with emphasis on the onboarding of newly hired staff or those with less experience and expertise in early clinical development.
* Oversees and supports the ongoing compliance of the PCRU with Pfizer Standards, ethical standards, ICH, regulatory and legal requirements, national and European laws on health and safety at work, fire prevention and any other appropriate legislation
* Reports to PCRU Medical Director
* Member of the PCRU Leadership team.
* Networks and collaborates with other Pfizer CRUs to ensure organizational consistency of standard operating procedures.
* Functional relationship to Clinical Services Director, Business Operations Director, Pharmacy and Regulatory Director, Medical and Scientific Advisor, and Safety Laboratory Head in areas of safety, ethical and regulatory oversight for study participants.
* Matrixed relationship to study teams and other peers in the PCRU for guidance in study management activities; to varied scientists and clinicians in CDO for optimal protocol design; and to multiple WRD departments as appropriate (Dev. Ops., Assay Laboratory, Pharm. Sciences) to implement and report outcome.
* Acts as PCRU Representative towards other Pfizer and non-Pfizer departments and customers.
* Collaborates across several Clinical Development and Operations department
QUALIFICATIONS / SKILLS
* Minimum Medical Doctor Degree post-graduate education/training is preferred, particularly in pharmaceutical medicine.
* Leadership/Management formal education and/or work specific training/experience (e.g. supervisory skills development; interview and selection).
* Evidence of appropriate education/training relative to early drug development/clinical study conduct.
* Minimum of 7 years of clinical experience of which 3 years in pharmaceutical or medical research (Prior experience in Phase 1 or exploratory research advantageous).
* Minimum of 3 years experience in a management position (including: conflict resolution, allocation of limited resources, staff development, and change facilitation).
* Experience in the preparation and delivery of scientific/management educational presentations.
* Participation in multifunctional, interdepartmental management teams.
* Exposure to exploratory development strategies and full development activities.
* Scientific and medical knowledge
+ Must have excellent working knowledge of medical conditions, research techniques and their respective application in clinical research.
+ Ability to review and understand emerging safety and efficacy profile of a drug candidate and recognize potential serious adverse effects. Ability to align clinical skill sets with protocol requirements to assure appropriate staffing for studies and optimal safety of the clinical trial participants.
+ Demonstrated understanding of the complexities and recent developments in exploratory research. Understanding of clinical pharmacology issues, and clear overview of the legal and regulatory aspects of early stage drug development.
+ Exposure to exploratory development strategies and full development activities.
* Managerial skills
+ Able to lead multi-disciplinary groups; ability to coach, manage and motivate staff.
* Team work
+ Participation in multifunctional, interdepartmental management teams.
+ Ability to lead diverse workgroups to accomplish business objectives within the allocated timeline.
+ Strong Interpersonal Skills.
* Business Oriented
+ Detail oriented, with ability to work in a fast-paced environment and to adapt ressources in order to accomplish business objectives.
+ Capacity to challenge existing paradigms in clinical research and to encourage novel study designs and research approaches.
+ Ability to support the improvement of study conduct, data capture and retrieval and submission processes, and to contribute to achieve departmental and WRD goals.
+ Ability to communicate in easily understandable language the complicated research principles and practices. Must be able to instruct and assist less skilled or inexperienced personnel in the performance of study activities.
* Finance awareness
+ Ability to develop budget estimates, justify costs and manage performance against budget.
* Language skills
+ Good written and verbal skills in English, French and Dutch.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Belgium - Brussels