Salary
💰 $169,700 - $282,900 per year
About the role
- In this role, you will: Develop and lead/co-lead highly complex projects, creating mid-term plans that impact results and leverage relationships to meet the needs of the Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit.
- Make decisions in complex problems, identify innovative options and solutions, and recommend courses of action impacting the Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit.
- Act independently on self-initiated projects, leveraging knowledge from others and exercising judgment in complex decisions within the Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit.
- Review work for effectiveness of results, with contributions evaluated based on business impact, and review the work of other colleagues.
- Be at the forefront of model-based drug development (MBDD), evaluating risks and facilitating drug development in close collaboration with R&D partners.
- Plan and direct clinical pharmacology components of clinical programs and studies, including protocol preparation, clinical phase oversight, and reporting.
- Provide expertise on clinical programs and studies across various therapeutic areas and portfolio segments, such as biosimilars, sterile injectables, and anti-infectives for established products.
- Collaborate closely with clinicians, statisticians, translational oncology scientists, and clinical operations colleagues to design, conduct, and report clinical trial results.
- Utilize Modeling and Simulation to integrate pharmacokinetics, pharmacodynamics, and patient characteristics for pediatric development, new indications, and product defense.
- Lead the team in adopting clinical pharmacology best practices, represent the discipline at senior organizational levels, and influence the external environment through publications and presentations.
Requirements
- BA/BS with at least 8 years of experience or MBA/MS with at least 7 years of experience or PhD/JD with at least 5 years of experience or MD/DVM with at least 4 years of experience.
- Strong technical proficiency in pharmacokinetic software such as Phoenix, NONMEM, and R.
- Excellent communicator with strong verbal, written, and presentation skills, coupled with strong interpersonal abilities.
- Deep understanding of clinical trial design, principles of clinical development, and related disciplines.
- Proven track record in managing clinical pharmacology activities and Model Informed Drug Development.
- Experience in global regulatory agency interactions.
- Ability to apply pharmacokinetic and pharmacodynamic concepts, including modeling and simulation, to clinical trial design.