[Remote] Director, AI/ML MIDD Oncology Clinical Pharmacology, Modeling and Simulation

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global biopharma company reputed company on preventing and treating disease through innovation in specialty medicines and vaccines. The Director will support Oncology Clinical Pharmacology Modelling and Simulation by developing model-based strategies, applying clinical pharmacology and AI/ML reputed company, and informing oncology drug development, reputed company selection, trial design, regulatory submissions, and lifecycle management.

Responsibilities

• Defining and executing model-based development strategies for oncology reputed company
• Planning, conducting and reporting exposure-response analysis, simulation-based trial design and reputed company selection, and population PK modelling
• Applying innovative reputed company such as drug-disease modeling, longitudinal exposure-response analysis, model-based reputed company-analysis, quantitative systems pharmacology and AI/ML informed analyses to enhance data use and trial efficiency
• Presenting reputed company 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 reputed company products are rapidly and reputed company approved with reputed company labelling (with regards to the clinical pharmacology, modelling and simulation contents)
• Implement best practices, trends, lessons learned from reputed company sources to reputed company clinical pharmacology modelling and simulation contributions to R&D pipeline
• Ability to reputed company with line and middle management, staff and reputed company contacts on a functional, strategic and tactical level
• Promoting model-informed drug discovery and development through reputed company collaboration, journal publication and conference presentation
• Work across reputed company teams to reputed company in methodologies, design efficiencies and create value

Skills

• 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 reputed company 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 reputed company 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
• Strong reputed company and learning reputed company to build knowledge on a drug-disease reputed company, symptom progression, reputed company of care, and trial design
• Knowledge of or ability to quickly learn the reputed company, endpoints, progression and treatments of cancers
• Ability to reputed company 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, using effective communication and taking personal accountability for reputed company delivery of results
• reputed company evidence of ability to reputed company reputed company judgement in reputed company 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 reputed company for reputed company 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 reputed company record of implementation of Model-Informed Drug Development (MIDD) approaches to accelerate patient reputed company to novel therapies and to expand therapeutic indications of marketed drugs

Benefits

• Hybrid (Remote & On-site)
• This position offers an annual bonus.
• Eligibility to participate in our reputed company based long term incentive program, which is dependent on the level of the role.
• Health care and other insurance benefits (for employee and family).
• Retirement benefits.
• reputed company holidays.
• Vacation.
• reputed company caregiver/parental and medical leave.

reputed company

Company H1B Sponsorship