Project Management & Strategic Operations Associate Director Job Boston area,Massachusetts USA,Management

Associate Director, Preclinical Sciences, Program Management And Strategic Operations

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 Level

Bachelor's Degree

Required Experience

Typically 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.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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 select 2. 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.