Senior Director, Project Management - Anti-Infectives
This role will serve as Research Project Lead (RPL) for the clinical development of anti-infectives assets for the RU from pre-clinical development to demonstration of proof of concept. The RPL will have a knowledge of anti-infectives, with a focus on antibacterials and disease mechanisms, and experience in clinical product development and program management. The RPL will be responsible for development of the Medicine Plan and leading execution of the cross-functional plan to agreed quality, timeline and milestones. The RPL will oversee and articulate program objectives, experimental results, work with project teams, supporting lines and team members to execute on medicine plans and logistics. The RPL will have oversight of R&D activities (pre-clinical, clinical pharmacology, clinical Regulatory, Pharm Sci, Patient Safety, etc). An ability to communicate within cross-functional and across multidisciplinary teams is essential. The RPL will be expected to share and present program progress and milestones to leadership and will be accountable for appropriate documents (reports, standard operation procedures, regulatory documents).
Serve as program management lead for cross-functional research and development activities for assigned anti-infectives pipeline assets.
Coordinate and implement medicine plan
Communicate development strategy, priorities, and direction to project representatives and Discipline Leaders and ensure effective partnership amongst team members to meet goals of program.
Maintain development timeline, delivery of milestones, and submission of regulatory documents.
Actively manage project risks, devising and implementing appropriate mitigation activities with multidisciplinary teams. Lead timely and effective communication of project risks and impact to senior leaders.
Communicate development status to senior leaders and act as a champion for the asset to ensure appropriate resources (budget and FTEs) are secured and deployed to facilitate delivery of the medicine plan.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Ph.D. with 10+ years of experience or advanced degree with equivalent experience in microbiology, biological sciences, chemistry, or a related field of research required.
Experience in Pharmaceutical R&D and knowledge of preclinical and clinical drug development and experience in advancing therapeutics into clinical studies.
Experience with regulatory documents and requirements for drug development.
Senior management experience in leading cross-functional drug discovery and/or development teams.
Understanding of clinical study protocol design.
Strong record of scientific achievement, management, and leadership.
Demonstrated ability to meet challenges and effectively manage team.
Excellent verbal and written communication skills are required.
Ability to work under deadlines.
Ability to effectively analyze and communicate complex information cross different disciplines and in a time sensitive manner.
Other Job Details:
Eligible for Relocation Package
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