Job Description General 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
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. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.