Director, Oncology Clinical Pharmacology MIDD AI/ML

About the role

This position requires an on-site office presence for 2-3 days per week. 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.

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
• Writing or reviewing clinical pharmacology components of regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology, modelling and simulation contents)
• Implementing best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline
• Interacting 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
• Working across matrix teams to innovate in methodologies, design efficiencies and create value

Qualifications

• A PhD in Quantitative Clinical Pharmacology and Pharmacometrics (e.g., pharmacology, engineering or statistics) or relevant Life Sciences discipline, and experience in using modelling/simulation to solve practical problems in industry or academia.
• A PharmD or Master degree in the same disciplines with an additional 4 years of relevant experience may be considered.
• 5+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling; and verifiable proficiency in pharmacometric tools
• 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.

Skills

• Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design
• Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of cancers
• Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results
• Clear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks
• Passion for quantitative clinical pharmacology and desire to innovate for better outcome
• Prior experience in Oncology Research and Development is a plus
• Excellent interpersonal skills with strong oral/written communication and presentation skills
• Strong track record of implementation of Model-Informed Drug Development (MIDD) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs

Benefits

The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.