Director, Oncology Clinical Pharmacology MIDD AI/ML

Job description

This position requires an on-site office presence for 2-3 days per week. We need a highly motivated and experienced Director to join our Oncology Clinical Pharmacology Modelling and Simulation (CPMS) department within Oncology Translational Medicine. The role focuses on delivering CPMS quantitative excellence to development programs, helping to inform and accelerate the development of innovative oncology therapies to 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, dose selection, and population PK modelling
• Applying innovative methods such as drug disease modelling, 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 to facilitate rapid and efficient product approval with optimum labelling (regarding the clinical pharmacology, modelling and simulation content)
• Implement best practices, trends and lessons learned from internal and external sources to further CPMS contributions to the R&D pipeline
• Interact with line and middle management, staff and external contacts on a functional, strategic and tactical level
• Promote 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

Basic Qualifications

• A PhD in Quantitative Clinical Pharmacology, Pharmacometrics or a related Life Sciences discipline, with experience in using modelling/simulation to solve practical problems in industry or academia. A PharmD or Master's degree with an additional 4 years of relevant experience may be considered.
• 5+ years of experience in mechanistic PK/PD and longitudinal disease modelling; and verifiable proficiency in pharmacometric tools such as NONMEM or R.
• 3+ years of experience 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.

Preferred Qualifications

• 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.
• Ability to keep up to date with and propose the implementation of new modelling approaches to inform drug development.
• 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.
• 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 is a plus.
• 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 approaches to accelerate patient access to novel therapies and expand therapeutic indications of marketed drugs.

Benefits

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $188,100 to $313,500. The US salary ranges take into account factors such as work location, 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. Benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Equal Employment Opportunity

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service, or any basis prohibited under federal, state or local law.

Accommodation

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