Associate Director Scientific Team

Job content

Summary

The Associate Director, Scientific Team provides leadership to the scientific team by managing, overseeing ongoing projects, planning upcoming projects, and providing scientific oversight as well as guidance. The incumbent will ensure that projects are performed in accordance with clinical protocols, SOPs and GLP/GCLP guidance when applicable. The incumbent is accountable for overall scientific/technical quality and integrity of projects and interacts with clients regarding technical/scientific aspects of the study and overall study conduct.; Acts as a key resource person in the mentoring/training of scientific personnel. Represents CellCarta at scientific meetings and participates in the preparation of scientific or technical materials. The Associate Director will participate in activities of scientific societies outside of CellCarta such as the participation in committee or initiatives.

The Associate Director will take a leadership role in oversight of regulatory compliance and in process improvement initiatives. The Associate Director will have overall accountability for ensuring regulatory compliance and meeting timelines for all projects.

Main Responsibilities

• Manage the Principal Scientist team; responsible of the performance management, the coaching and professional development of the team members
• Implements performance indicators within the scientific team
• Works in close collaboration with the Senior Director of Operations for effective communication and processes between both teams
• Ensures that principal scientists perform all work in accordance with GLP and CellCarta SOPs. Identifies area for improvement and creates new initiatives to correct deficiencies
• Actively participate in the preparation and conduct of audits for clients or regulatory bodies. Communicate audit findings to subordinates. Ensure that all subordinates follow through with completion of audit findings. Create action plans for ensuring findings are not repeated. Take a leadership role in driving process improvements based on audit findings.
• Take a leadership role in the oversight of investigations/CAPAs. Assist and mentor direct reports in troubleshooting activities and CAPAs. Ensures that all "lessons learned" are communicated with all team members.
• Ensure that all study-related data are appropriately maintained and archived.
• Meet the needs of internal clients: Laboratory Operations, DAU, QA, BD, Finance and Senior Management. Ensure that the Scientific Team meets internal client needs. Identify areas for improvement and create new initiatives when the scientific team is unable to meet internal client needs.
• Perform work within specified timelines, proactively communicate any failure to meet timelines
• Oversee the planning and progress of projects assigned to direct reports. Accountability to ensure that direct reports deliver within established timelines and that delays are communicated in a proactive manner to clients with action plan to minimize the delays. Take corrective measures as needed to ensure timelines are met. Hold subordinates accountable. Inform Vice President of Immunology of delays in timelines and plans for corrections. Put corrective action plans in place as necessary.
• Identify resource constraints and inefficiencies and work with management to resolve. Deliver solutions to alleviate constraints and inefficiencies.
• Review and approve the reports prepared by subordinates.
• Take a leadership role in setting the standards for data interpretation based on validation results and current best practices in the industry. Assist and mentor direct reports in data interpretation activities.
• Present work internally and external as required. Ensure that subordinates are creating content for presentations via communication with clients and external committees. Bring concepts to the department regarding presentation content.
• Actively participates in assay plan design and scientific writing for client proposal.
• Interact with Assay Development Team in the development of new assays as per client needs, including the assay validation phase. Coach and guide direct reports on their interactions.
• Coach and guide direct reports on their interactions with laboratory personnel (e.g., research assistants and technicians) assigned to their projects.
• Interact regularly with clients, and CellCarta management to address project issues in a timely manner and to the satisfaction of the client. Coach and guide direct reports on client interactions.
• Regularly attend Assay Life Cycle meetings.
• Regularly attend Review Team meetings and makes sound recommendations regarding Principal Scientist assignments to the Assay Plan Team.
• Keeps abreast of advances in flow cytometry instrumentation, reagents, standardization, validation.
• Make recommendations for new platforms and processes.
• Identifies and implements performance indicators within the scientific team
• Works in close collaboration with the Senior Director of Operations for effective communication and processes between both teams

Education

• PhD in immunology

Main Requirements

• Minimum of 5 years of experience in people management in addition to a minimum of 5 years in the industry (CRO or biopharma)
• Minimum of three years of experience in project management
• Expert in Immunology, immune monitoring methodologies, clinical trial design, regulations. Good understanding of drug development (discovery, pre-clinical and clinical phases). Good understanding of biomarkers assays in support of drug development
• Experience with flow cytometry techniques and applications in the field of immune monitoring including assay design as well as handling complex data set of multi-color panels.
• Knowledge of newest advances in instrumentation, standardization, and validation. Knowledge of non-flow cell-based assays to monitor adaptive and innate immune responses
• Expert level proficiency in working with third party flow cytometry data analysis packages and Microsoft Office products
• Strong knowledge and understanding of GLP/CAP/CLIA regulations and other regulatory guidelines sufficient to carry out GLP studies.
• Strong knowledge of current validation requirements for cell-based analysis.
• Advanced level of understanding and analytical skills to interpret data and draw conclusions. Seeks creative solutions for complex dataset based on novel technologies and software. Ability to see patterns and challenges across projects and studies
• Communicate clearly and confidently and has excellent interpersonal and teaching skills. Has ability to confront constructively and maintain good relationship with internal/external clients. Has ability to present high-level summaries to senior management. Has ability to defend ideas in a professional manner when challenged.
• Excellent time management and organizational skills to meet deadlines in a fast-paced, changing environment. Commitment to maintain quality under all situations and all challenges. Accountable for ensuring that subordinates meeting all assigned deliverables. Accountable for ensuring that the Scientific Team meeting all assigned deliverables.
• Excellent record keeping, attention to details and commitment to achieve good quality work. Ability to perform quality review of various documents (workplan, reports, SOP/CSP, deviations). Ability to prepare/review and critique high-quality reports. Contributes to new processes and templates for higher quality reports. Contributes solutions to existing issues with reports (content, quality, timeliness)
• Has ability to oversee and guide troubleshooting projects. Has the ability to apply lessons learned from troubleshooting activities into Process Improvements. Drive innovation and process improvements.
• English proficiency (written and spoken) is required; French is an asset