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We will lean on you to lead the development and implementation of pre-clinical and clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial). You will de...
Drive Excellence: Your focus is to provide meaningful guidance and resources to scientific and administrative leaders. You recognize that expert insights will drive the health of the Institute...
Oversee a team of development scientists and execute studies to evaluate and optimize cell therapy manufacturing process.
Develop, implement, and manage onboarding and ongoing training programs for field MSL team and in-house Medical Affairs staff in a manner consistent with best practices and applicable laws, regulation...
Development of RFPs for protocol design, analytic plan, conduct, analyses of observational safety studies such as systematic literature reviews and meta-analyses, indirect treatment comparisons, obser...
Organizational leadership to support a culture that is readily able to identify credible opportunities for new areas of research collaborations, technologies and innovation, which includes educating t...
Proactively identifies project risks before they arise and develops contingency plans; escalates issues related to quality, timelines, and budget and provides recommendations to upper management for r...
Review and approval of submission documents, including clinical study protocols and reports, statistical analysis plans, investigator brochures, aggregated safety reports and other documents as needed...
The most effective, appropriate and timely way. Lead enterprise development of intranet and other channels, measuring effectiveness and evolving for growth...
Responsible for development, planning, and selling to Named Accounts. Collaborate with Marketing and Business Development teams to conceive and execute effective demand generation campaigns...
Line Management for members of the COPL organization. Responsible for performance management and optimization of members of the COPL team to achieve a consistently highly performing effective COPL tea...
Ensure that audit results are formally and consistently tracked, recorded, reported, trended. Ensure that corrective/preventive actions have been identified, documented and are effective...
Works closely with Clinical Development staff and peers to ensure that study plans are aligned and in support of broader goals and objectives and that there is consistency in approach to management of...
Develop, manage, and set the strategic direction of the company’s protein platform, including protein production and QC, assay development, validation, and scale-up...
Uncompromising integrity, character and intellectual honesty; one who strives to do the right thing and deliver quality results; an executive with the courage and conviction to speak their position...