Job DescriptionGeneral Summary: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.
Key Duties & Responsibilities- 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
Required Education LevelBachelor's Degree
Required ExperienceTypically requires 10 years of work experience or the
equivalent combination of education and experience
Required Knowledge/Skills- 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
Preferred Skills:
- Knowledge of or experience working in an outsourced preclinical model
- Preclinical Regulatory experience in both IND/CTA and global marketing submissions
Pay Range:$155,700 - $233,500
Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
Flex Designation:Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:In this Hybrid-Eligible role, you can choose to be designated as:
1.
Hybrid: work remotely up to two days per week;
or select2.
On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
