Site Name: USA - North Carolina - Research Triangle Park, USA - Massachusetts - Waltham, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence
Posted Date: Apr 28 2021
We have an exciting opportunity at GlaxoSmithKline (GSK) for a highly innovative Quantitative Clinical Pharmacologist to join our team supporting infectious disease, rare disease and specialty therapeutic areas as part of our Clinical Pharmacology Modelling & Simulation team.
As the Director of Clinical Pharmacology Modelling and Simulation (CPMS) 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 and 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.
This position can be based at GSK US at the Collegeville, PA or Raleigh-Durham, NC or Waltham, MA locations and can be remote based within the east coast time zone.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- 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
We are looking for professionals with these required skills to achieve our goals:
- Advanced training with a degree such as PhD, PharmD or MD to enable a successful career in quantitative clinical pharmacology in pharmaceutical research and development
- 7 or more years of industry experience in clinical pharmacology, modeling, simulation with track record of publications.
- Must have experience in population PK analysis, PK/PD, Dose-response analysis including use of NONMEM
- Experience in clinical pharmacology and its utility in drug development, including pharmacokinetics, pharmacometrics approaches, and model-informed drug discovery & development
- Experience in designing, analysing and reporting clinical studies, with a simulation- or modelling-based approach where appropriate
- Experience with the mechanism, endpoints, progression and treatments of diseases in infectious disease and other relevant therapy areas
If you have the following characteristics, it would be a plus:
- Ability to articulate and advocate for the use of modeling and simulation approaches to address drug development issues and questions.
- Drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design.
- Ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks.
- Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of infectious/rare diseases
- Familiarity with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs
- Understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical development plans and studies
- Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaborating
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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