Director, Preclinical Program Management Job at Vertex Pharmaceuticals
Job Description
General Summary:
Vertex Pharmaceuticals is working to discover and develop innovative cell and gene therapies with the potential to provide transformative benefit to patients. Vertex is currently advancing multiple stem cell-based and gene therapies targeting Type 1 Diabetes, muscular dystrophies and hemoglobinopathies. Vertex is seeking a creative, self-motivated Director-level Program Management and/or Operations individual responsible for management and coordination of all nonclinical activities within the Preclinical Development team across all Cell and Gene Therapy programs, study operations and regulatory filings, and budgeting and forecasting of the overall nonclinical program plan. This is a fantastic opportunity to work on cutting edge science, apply state-of-the-art technologies, and take part in discovering and developing next-generation cell and gene therapies for these diseases.
Key Duties and Responsibilities:
- Responsible for providing oversight and management of programs and groups focusing on multiple Vertex Cell and Gene Therapies. Direct the conduct and quality of all aspects of program management, study operations, and activities across these disease areas.
- Coordinate and drive planning activities, including milestone setting, resource planning, scenario planning, and developing an integrated program plan based off of cross-functional input and assumptions.
- Contribute to the preclinical pharmacology strategy and plans, including defining key milestones, decision points and timelines, identifying risks and mitigation strategies, and study planning and execution.
- Supports the project leaders and the project team in the development of the program strategy by planning and tracking activities in late lead optimization through preclinical development.
- Reviews and compiles the developed plans, forecasts and maintains program budgets, and logistics for projects and assists in scenario planning to provide alternate development plans, along with the associated assumptions and risks.
- Oversee CRO management for outsourced preclinical activities across multiple programs
- 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 technologies.
- Establish and foster effective communication and collaborative relationships with key internal and external stakeholders across Vertex sites and departments, including preclinical research and safety teams, clinical biomarkers, and clinical development to ensure team-based approach with efficient workflow.
- Ensure all preclinical pharmacology studies are conducted in compliance with the appropriate regulatory guidance documents and are aligned with regulatory agency requirements (e.g. Good Laboratory Practices) and in accordance with departmental policies, practices and procedures (SOPs, good documentation, data integrity best practices and safety procedures).
Knowledge and Skills:
- Hands on experience in leading program management and operational activities in early and late preclinical development is required.
- Pharmaceutical drug discovery and development comprehensive knowledge.
- Expertise in CRO management and oversight for in vivo studies to ensure timely progression of preclinical studies with the goal of advancing high-quality drug candidates to the clinic.
- Act as the primary contact for CRO partners to track key activities, trouble shoot issues, ensure compliance with contract terms and monitor performance metrics.
- Support protocol development in collaboration with study lead for external preclinical studies.
- Broad and comprehensive knowledge of GLP regulations. Familiarity with the preclinical regulatory requirements for gene therapy/editing and cell therapy programs is strongly preferred.
- Excellent communication skills with the proven ability to work effectively as a member of a multidisciplinary team.
- Attention to detail and careful record-keeping, ability to think critically, excellent organizational skills and ability to manage multiple projects, excellent oral and written communication skills.
- Ensures high-performing project teams by monitoring and assessing team effectiveness at both team and individual levels.
- Knowledge of project management tools and software (for example: MS Project Online, Smart Sheet, and Think Cell, etc.).
Education and Experience:
- A PhD in Biological sciences, Biochemistry and/or other biological discipline and 7+ years of relevant biotech or pharmaceutical industry experience, or MS with 10+ years of experience is preferred. Candidates with other degrees and significant experience are considered.
- 3+ years in a program management and/or operations role. Hands on experience in leading program management and operations activities for programs in preclinical development is required.
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.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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.
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