Director, Quantitative Clinical Pharmacologist

GSK•Waltham, MA

4d•Hybrid

About The Position

Director, Quantitative Clinical Pharmacologist GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human genetics and advanced technologies, such as functional genomics and AI/ML. Job Purpose: We have an exciting opportunity at GSK for a highly innovative Quantitative Clinical Pharmacologist to join our team supporting infectious disease area. GSK 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. You will be part of a science driven group delivering clinical pharmacology and modelling & simulation excellence to research and development programs. You’ll have the opportunity to work on both small molecules and biologics in the Vaccines and Infectious Disease therapeutic area. Responsibilities generally commence post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management. Key Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.

Requirements

Advanced Degree in Life science such as PhD, PharmD or MD to enable a successful career in quantitative clinical pharmacology in pharmaceutical research and development.
5 years + experience in clinical pharmacokinetics, modelling & simulation and model-informed drug development including designing, analysing and reporting clinical studies.
2 years + experience of pharmacokinetic and pharmacodynamic principles and commonly applied models through previous projects in pharmaceutical industry roles or equivalent.
2 year + experience working with common tools for quantitative clinical pharmacology such as NONMEM, R, WINNONLIN, SIMCYP, SAS and MATLAB through previous hands-on projects.
1 year + experience with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs through direct involvement in regulatory submission activities in previous roles.
1 year + experience through previous roles in applying appropriate FDA and ICH guidelines in the design of clinical development plans and studies.

Nice To Haves

Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in infectious disease and other relevant therapy areas.
Ability to communicate clearly and succinctly with the audience in mind, both orally and in writing.
Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results.
Sound judgement, analytical mindset and problem-solving skills.
Ability to effectively multi-task and deliver results on time.

Responsibilities

Contribute, as a member of a multi-disciplinary team, to the design of an efficient clinical development program, robust registration package and support life cycle management of an asset
Provide optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development, risk management, and registration of compounds
Play a central role in predicting human dose range, characterizing exposure-response relationship and justifying dose recommendations for special populations.
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 strategy and discuss outcome of model-based approaches via interactions with governance boards and regulatory agencies
Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy
Promote model-informed drug discovery and development (MID3) through external collaboration, journal publication and conference presentation.
Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics
Identify opportunities to utilize in silico PBPK approaches to replace in vivo clinical studies to explore the impact of DDI and special populations on PK where appropriate
Write sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packages
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
Innovate through working effectively with colleagues in the department and other matrix team members, including statisticians, biologists, physicians and drug metabolism scientists

Benefits

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.

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