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The Vice President, Quantitative Sciences & Development provides strategic, scientific, and operational leadership for the company's Clinical Pharmacology, Pharmacometrics, Toxicology, DMPK, Biostatistics, Statistical Programming, and Clinical Data Management functions across all phases of drug development.

This executive is responsible for developing and overseeing execution of integrated quantitative strategies that support efficient translation from non-clinical development, clinical development, regulatory submissions, and evidence generation while ensuring delivery of high-quality, inspection-ready clinical data and statistical analyses. The VP serves as a key member of the Clinical Leadership Team and partners closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, Quality Assurance, and external CROs to advance the company's portfolio.

Develop and implement the company's Clinical Pharmacology, Biometrics and Data Sciences strategy aligned with corporate development objectives.

Serve as a key member of the Clinical Leadership Team.

Build organizational capabilities to support a growing clinical pipeline.

Lead organizational planning, budgeting, resource allocation, and vendor strategy.

Represent Clinical Pharmacology, Data Management, and Biometrics in governance committees and executive reviews.

Provide strategic oversight for:

• First-in-human (FIH) study design
• SAD/MAD studies
• Food-effect and drug-drug interaction (DDI) studies
• QT/QTc and organ impairment studies
• Population PK, PBPK modeling, exposure-response analyses, dose optimization, and model-informed drug development (MIDD)
• Nonclinical toxicology strategy, including general, reproductive, developmental, genotoxicity, and carcinogenicity studies, as applicable
• Guide clinical pharmacology and toxicology strategy across all phases of development.
• Review and approve PK/PD and toxicology protocols, analysis plans, study reports, and regulatory submissions.
• Interpret nonclinical safety data to support first-in-human studies, dose selection, and benefit-risk assessments.
• Ensure compliance with FDA, EMA, PMDA, and ICH guidance and represent the function in regulatory interactions and cross-functional governance.

Provide strategic oversight for all biostatistical activities supporting clinical development.

Responsibilities include:

• Develop statistical strategy across the clinical development portfolio.
• Oversee study design and statistical methodology.
• Review and approve:
• Statistical Analysis Plans (SAPs)
• Protocol statistical sections
• Interim analyses
• Adaptive design methodologies
• Integrated summaries
• TLFs (Tables, Listings, and Figures)
• Guide sample size estimation, endpoint selection, multiplicity strategies, estimands, and innovative trial designs.
• Support Data Monitoring Committees (DMCs), Independent Review Committees (IRCs), and interim decision-making.
• Provide statistical leadership for:
• NDA/BLA submissions
• FDA Type B/C meetings
• EMA Scientific Advice
• PMDA interactions
• Ensure statistical integrity and regulatory compliance across all studies.

Provide executive oversight of statistical programming activities including:

• SDTM and ADaM dataset development
• TLF (Tables, Listings, and Figures) generation
• CDISC implementation
• SAS and R programming standards
• Submission-ready datasets
• Define.xml preparation
• Regulatory submission programming
• Automation and programming innovation
• Validation and quality control processes

Establish efficient programming standards that ensure timely database analyses and global submission readiness.

• Provide executive oversight of all Clinical Data Management activities.
• Ensure high-quality, inspection-ready clinical databases.
• Oversee:
• IWRS (Interactive Web Response System)/IRT (Interactive Response Technology) design
• Database design
• CRF/eCRF development
• Data review plans
• Data cleaning
• Medical coding
• Database lock
• Data quality metrics
• Establish enterprise data standards including:
• CDISC SDTM
• CDASH
• Controlled Terminology
• Ensure timely delivery of clean data for interim analyses and regulatory submissions.
• Lead implementation of innovative technologies including:
• Risk-based data review
• Centralized monitoring
• AI-assisted data review
• Electronic Clinical Outcome Assessments (eCOA)
• Wearable device integration
• Decentralized clinical trial data capture

Partner closely with:

• Clinical Development
• Clinical Operations
• Regulatory Affairs
• Medical Affairs
• Safety/Pharmacovigilance
• Medical Writing
• Clinical Supply
• Quality Assurance
• Commercial
• Health Economics & Outcomes Research (HEOR)

• Provide clinical pharmacology leadership for regulatory interactions.
• Lead preparation of:
• Clinical Pharmacology Summary
• Module 2.7 documents
• Module 5 components
• NDA/BLA/MAA submissions
• Support FDA Type A/B/C meetings, End-of-Phase meetings, and Advisory Committees.
• Respond to global regulatory information requests.

• Select, oversee, and evaluate CROs and specialty vendors.
• Establish KPIs and performance metrics.
• Manage budgets and contracts.
• Ensure vendor compliance with GCP and company quality standards.

• Ensure compliance with:
• ICH GCP
• FDA regulations
• EMA guidance
• 21 CFR Part 11
• GCDMP
• Company SOPs
• Maintain inspection readiness.
• Support regulatory inspections and audits.

• Build, mentor, and lead high-performing Clinical Pharmacology, Biometrics and Data Management teams.
• Recruit and retain top scientific and operational talent.
• Foster a culture of innovation, collaboration, accountability, and continuous improvement.
• Develop succession plans and leadership capabilities.

PhD, PharmD, MD, or equivalent advanced degree in:

• Clinical Pharmacology
• Pharmaceutical Sciences
• Pharmacokinetics
• Biomedical Sciences
• Biostatistics
• Medicine
• Related scientific discipline

Work Experience:

• 15+ years of progressive pharmaceutical