Are you energized by leveraging your clinical pharmacology and pharmacometrics skills to accelerate the development of oncology therapeutics? If so, this Clinical Pharmacology Manager role could be an exciting opportunity to explore.
We have flexibility to hire at different levels depending on a candidate's experience and skill set.
As a Manager Clinical Pharmacology Modelling and Simulation (CPMS) you will be part of a large science driven team delivering clinical pharmacology and modelling & simulation excellence to research and development programs. You'll have the opportunity to work on a wide diversity of therapeutic modalities including antibody-drug-conjugates and cell therapy approaches primarily in the Oncology Therapeutic area. CPMS responsibilities generally commence post-lead optimization with accountability occurring from approximately 6 months prior to FTIH through to life cycle management.
At GSK we are proud to combine both clinical pharmacology and modeling & simulation (M&S) accountabilities into one role aiming to bring the value of model-informed drug development to our R&D portfolio.
GlaxoSmithKline provides a supportive environment for scientists who are aspiring to learn, to contribute and to make impact on business decisions through innovation, expertise, and influence.
This position can be based at GSK US at the Collegeville, PA; Waltham, MA; or RTP, NC, or remote.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Why you?Basic Qualifications:
- Contribute, as a member of a multi-disciplinary team, to the design of an efficient quantitative clinical development program, robust registration package and support life cycle management of assets
- Play a central role in predicting human dose range, characterizing exposure-response relationship and justifying dose recommendations for later studies and for special populations.
- Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics
- Develop mathematical models to understand disease, its progression, and drug pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performance
- Present the CPMS strategy and discuss outcome of model-based approaches via interactions with project teams, governance boards and regulatory agencies
- Write sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packages
- Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy
- Advocate for the use of model-informed drug discovery and development (MID3) in teams and through external collaboration, journal publication and conference presentation.
- Innovate through working effectively with colleagues in the department and other matrix team members, including: development team leaders, statisticians, biologists, physicians and drug metabolism scientists
- Learn and apply emerging modelling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality; collaborate with external field-leading teams for methodology application
We are looking for professionals with these required skills to achieve our goals:
- Advanced training with a degree such as PhD, PharmD and MD in Pharmaceutical Sciences, (Bio)Engineering, Mathematics, Statistics, Medicine or related field
- One or more years experience applying pharmacokinetic and pharmacodynamic principles and commonly applied pharmacometric models
- One or more years experience utilizing tools for quantitative clinical pharmacology such as NONMEM, R, Monolix, SAS and/or MATLAB
If you have the following characteristics, it would be a plus:
- Solid experience with advanced pharmacometric approaches such as tumor size kinetics and joint models, or model-based meta-analysis, or adaptive dosing simulations, and/or mechanistic PKPD modeling
- At least 2 years post-graduation experience in a fellowship or industry environment
- Experience of model-informed drug development strategies within pharmaceutical industry
- Experience in designing, analyzing and reporting clinical studies, with a simulation- or modelling-based approach where appropriate
- Familiarity with M&S contributions to regulatory submission documents
- Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in oncology.
- Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
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