# Director, AI/ML MIDD Oncology Clinical Pharmacology, Modeling and Simulation

**Company**: GSK
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Salary**: $188,100 to $313,500
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Massachusetts---Waltham/Director--AI-ML-MIDD-Oncology-Clinical-Pharmacology--Modeling-and-Simulation_446353?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
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## Description

We have an exciting opportunity at GSK for a highly motivated and experienced Director to join our team supporting the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) department within Oncology Translational Medicine.

This role focuses on delivering CPMS quantitative excellence to development programs, helping to inform and accelerate the development of innovative oncology therapies by ensuring they reach the right patients, at the right dose, and at the right time.

Responsibilities:

- Defining and executing model-based development strategies for oncology projects

- Planning, conducting and reporting exposure-response analysis, simulation-based trial design and dose selection, and population PK modelling

- Applying innovative methods such as drug-disease modeling, longitudinal exposure-response analysis, model-based meta-analysis, quantitative systems pharmacology and AI/ML informed analyses to enhance data use and trial efficiency

- Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies

- Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions

- Write or review clinical pharmacology components of regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling

- Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline

- Ability to interact with line and middle management, staff and external contacts on a functional, strategic and tactical level

- Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation

- Work across matrix teams to innovate in methodologies, design efficiencies and create value

Requirements:

- A PhD in Quantitative Clinical Pharmacology and Pharmacometrics or relevant Life Sciences discipline, and experience in using modelling/simulation to solve practical problems in industry or academia

- 5+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling; and verifiable proficiency in pharmacometric tools NONMEM or R

- 3+ years of experience in planning, performing, and reporting analysis of clinical data per industry and regulatory standards

- Expertise in applications of AI/ML in Clinical Pharmacology and Pharmacometric analyses with innovative methodologies and efficiency applications

Benefits:

- Health care and other insurance benefits (for employee and family)

- Retirement benefits

- Paid holidays

- Vacation

- Paid caregiver/parental and medical leave

- Annual bonus and eligibility to participate in share-based long-term incentive program

## Skills

### Required
- Drug Design
- Drug Development
- Drug Discovery Process
- Medication Safety
- Molecular Modeling
- Pharmaceutical Regulatory Compliance
- Pharmaceutical Sciences
- Pharmacodynamics
- Pharmacokinetics
- Pharmacology
- Pharmacometrics
- Pharmacovigilance
- Study Design
- Target Validation

### Nice to have
- Strong drive and learning agility to build knowledge on a drug-disease system
- Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of cancers
- Ability to keep up-to-date with and propose the implementation of new modeling approaches to inform drug development
- Demonstrated aptitude for productive collaboration in a multi-discipline team
- Clear evidence of ability to make sound judgement in complex situations and adapt to changing business needs
- Experience in the design, analysis, interpretation and reporting of Clinical Pharmacology studies per industry and regulatory standards
- Passion for quantitative clinical pharmacology and desire to innovate for better outcome
- Prior experience in Oncology Research and Development
- Experience working with senior stakeholders in a cross functional environment
- Excellent interpersonal skills with strong oral/written communication and presentation skills
- Strong track record of implementation of Model-Informed Drug Development (MIDD) approaches

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