Clinical Project Director
Our client is a cutting edge Canadian organization in the pharmaceutical industry. They have partnered with Bryan Forrest of Lock Search Group to assist them in their search for a Clinical Project Director to join their team in Burlington.
The Clinical Project Director will primarily be responsible for overseeing clinical trials and project initiatives where the company may participate as a drug supplier.
- Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Teams (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
- Determine company’s Clinical Operations FTEs required to efficiently support clinical trials run by CROs or Publicly Funded third parties and provide regular updates and recommendations to the CSQO.
- Support the CSQO in the development of the annual Clinical Operations budget.
- Responsible for the negotiations of agreements and oversight of critical suppliers, sub-contractors related to the activities of the department in compliance with approved budgets.
- Ensure potential study risks are escalated to the attention of the CSQO when appropriate.
- Develop clearly defined strategies with the CSQO and selected CRO and lead or contribute to assigned global, cross-functional interdisciplinary, high priority initiatives and process improvements.
- Directs the preparation of progress reports and presentations and ensures that CSQO is kept informed in a timely manner of current status, progress, and future prospects of the programs.
- Monitor compliance to legal guidelines, internal policies and quality standards.
- Prioritizes strategic activities according to corporate objectives.
- Thorough understanding of biopharmaceutics, Pharmacokinetics/Pharmacodynamics and Clinical Study Design
- Oversee clinical projects and related activities including but not limited to trial timelines, budgets, resources and vendors.
- Develop effective working relationships with experts to support clinical trials as needed.
- Coaches, mentors and develops roles and responsibilities of managers under supervision.
- Create a culture of courageous leadership, creativity and collaboration by cooperating across all relevant business units and maintaining effective working relationships with interfacing groups.
- Oversees and approves study essential documents and plans provided by CROs.
- M.Sc. or Ph.D degree in life sciences
- A minimum of 10 years of experience in clinical operations including the conduct of late-stage clinical studies
- In depth knowledge of clinical trial processes, data management, electronic data capture systems, database programming, clinical operations, biometrics, quality management, and systems applications to support operations
- Working knowledge of the relationship and regulatory obligation of CROs in relation with pharmaceutical / biotechnological companies
- Extensive knowledge of FDA, ICH and GCPs regulations
- Proven track of incremental management responsibilities
- High attention to detail, and excellent proofreading and editing skills
- Excellent knowledge of the overall drug development process
- Demonstrated ability in project management, with overlapping priorities and aggressive timelines
- Ability to lead, influence, create and work within cross-functional team environment
- Strong personal presence with ability to command respect through exercise of sound business judgment and clear decision-making
- Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing
- High level competence in pertinent software (e.g., Word, PowerPoint, EndNote)
- Fluent English, French is an asset
- The candidate may be required to travel on a periodic basis
To apply, please submit a copy of your resume in confidence to Bryan Forrest via the “apply now” button.