The Associate Director, Preclinical Sciences, Program Management and Strategic Operations, will be responsible for the integration, creation, and execution of multiple complex pharmaceutical development/regulatory plans. By collaborating closely with Project Leaders, cross-functional Project Team members, and contract research partners, the incumbent develops and maintains fully integrated project plans to ensure that deliverables are successfully executed, are in accordance with project and disease area objectives, and are within budget.
The incumbent is also responsible for comprehensive communication, including status reporting, risk management and escalation of issues to cross-functional stakeholders and Senior Management.
- With support, establish project team operating norms and measure performance
- Independently leads teams for critical development projects
- Reviews and compiles the developed plans, budgets, and logistics for projects and assists in scenario planning to provide alternate development plans, along with the associated assumptions and risks
- Works directly with contract research organization (CRO) partners on scheduling and reporting of important preclinical deliverables
- Effectively summarizes key information such as program progress, timelines updates, and
risk/opportunity assessments for periodic presentations to management
- Methodically tracks all high-level program deliverables, and seek out innovative ways to stay abreast of this multi-dimensional task, such as new operational practices or advanced technology
- Leads and supports worldwide regulatory submissions from a nonclinical perspective
- Forecasting and maintaining program budget, including oversight of programs of direct reports
- Mentors staff on professional and ethical development, motivate personnel, and resolves conflicts
- Upon request and in conjunction with supervisor, craft goals for direct reports and ensure linkage to personal goals in support of corporate goals
- Apply subject matter expertise to mentor subordinate managers and high-level professionals
- May serve as study representative on preclinical studies.
- Manage one or more direct reports
- Broad and comprehensive knowledge of GLP regulations
- Comprehensive knowledge of pharmaceutical drug discovery and development (full life-cycle)across multiple preclinical
disciplines (e.g., research, drug metabolism and pharmacokinetics, toxicology, biomarkers, etc.)
- Extensive understanding of preclinical regulatory submissions documentation and process
- Excellent written and oral communication skills
- Exhibits an understanding of disciplines beyond own specialty area
- Effectively influences decision and outcomes across teams
- Knowledge of or experience working in an outsourced preclinical model
- Preclinical Regulatory experience in both IND/CTA and global marketing submissions