![GlaxoSmithKline](https://www.energyjobline.com/sites/default/files/styles/squared_logo/public/job-logo/get-logo.php__367086.png?itok=C3I6tB4D)
Director of Clinical Pharmacology Modeling and Simulation
1 month ago
Posted Date: Jul
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 GlaxoSmithKline (GSK) for a highly innovative Quantitative Clinical Pharmacologist to join our team supporting infectious disease area as part of the global department of Clinical Pharmacology Modelling & Simulation. 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.
As a 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 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.
- 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
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Advanced Degree in Lifesciences 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
- Experience of pharmacokinetic and pharmacodynamic principles and commonly applied models through previous projects in pharmaceutical industry roles or equivalent
- Experience working with common tools for quantitative clinical pharmacology such as NONMEM, R, WINNONLIN, SIMCYP, SAS and MATLAB through previous hands-on projects
- Experience with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs through direct involvement in regulatory submission activities in previous roles
- Experience through previous roles in applying appropriate FDA and ICH guidelines in the design of clinical development plans and studies
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Demonstrated expertise in specific technical areas related to modelling and simulation, and/or the vaccines and infectious disease therapeutic area
- 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
#LI-GSK*
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or 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.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
-
Senior Director, Vaccine Clinical Research
2 months ago
Collegeville, Pennsylvania, United States Pfizer Full timeROLE SUMMARYThe clinician medical monitor should be able to function independently and have direct experience with all the steps in designing and delivering results of clinical trials by applying extensive expertise and in-depth knowledge of clinical research to lead global clinical research programs and registration activities across one or more clinical...
-
Clinical Development Director Respiratory
1 month ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - Upper Providence, UK - London - New Oxford StreetPosted Date: Aug 1 2024We're combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this...
-
Director, Clinical Research
3 months ago
Collegeville, Pennsylvania, United States Pfizer Full timeROLE SUMMARYThe clinician medical monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety.The clinician medical monitor may be required to design...
-
Clinical Operations Manager
5 days ago
Collegeville, Pennsylvania, United States Columbia Cottage Full timeJob OverviewColumbia Cottage is seeking a dedicated full-time Resident Services Director to manage the clinical operations at our assisted living facility. Are you a registered nurse (RN) or a licensed practical nurse (LPN) with leadership experience? Do you aspire to work for a respected and growing assisted living organization that appreciates your...
-
Clinical Operations Manager
5 days ago
Collegeville, Pennsylvania, United States Columbia Cottage Full timeJob OverviewColumbia Cottage is seeking a dedicated full-time Resident Services Director to lead the clinical operations at our assisted living facility. Are you a registered nurse (RN) or a licensed practical nurse (LPN) with experience in management? Do you aspire to work for a respected and flourishing assisted living organization that appreciates your...
-
Clinical Operations Manager
6 days ago
Collegeville, Pennsylvania, United States Columbia Cottage Full timeJob OverviewColumbia Cottage is seeking a dedicated full-time Resident Services Director to lead the clinical operations at our assisted living facility. Are you a registered nurse (RN) or a licensed practical nurse (LPN) with experience in management? Do you aspire to be part of a respected and flourishing assisted living organization that appreciates your...
-
Precision Medicine Operations
3 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - StevenagePosted Date: Aug Are you energized by the challenge of supporting clinical trial operations and getting ahead of disease together for the benefit of patients? If so, we have a great opportunity for you on the Precision Medicine Project Management and Operations (PMedPMO) team at...
-
Expressions of Interest
1 month ago
Collegeville, Pennsylvania, United States GlaxoSmithKline LLC Full timeReference #: 392414Site Name: USA - Pennsylvania - Upper ProvidencePosted Date: Apr 2 2024Are you an ambitious Oncology Clinical Development professional looking to advance your career in the pharmaceutical industry? Take a look at this position and engage with us to explore broader opportunities in GSK's Oncology Clinical Development division today.The...
-
Sr. Director/TL
2 months ago
Collegeville, Pennsylvania, United States Pfizer Full timeROLE SUMMARYThe Data Science & AI team within Commercial Analytics & AI (CAAI) is focused on turning data into actionable intelligence, helping Pfizer to remain competitive and innovative in today's data-driven environment. We are crucial in extracting insights from large datasets to drive strategic decisions. Collaborating closely with experts from various...
-
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeSite Name: UK - London - New Oxford Street, Mississauga, Stevenage, USA - Pennsylvania - Upper Providence, Waltham, Warsaw, WavrePosted Date: Jul At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and...
-
Director, Application Security
2 weeks ago
Collegeville, Pennsylvania, United States Pfizer Full timeROLE SUMMARYPfizer's Global Information Security (GIS) organization delivers proactive cyber defense for the global enterprise. Our mission is to secure all of Pfizer's digital information assets, from scientific breakthroughs to manufacturing, and out to the patients we serve. We achieve this through world-class talent, top-tier technologies, best...
-
Executive Administrative Assistant
2 months ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - Upper ProvidencePosted Date: Jul At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are...
-
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, USA - Massachusetts - WalthamPosted Date: Aug Are you energized by a highly-visible scientific leadership role that allows you to drive and shape scientific innovation? If so, the Executive Director, Diagnostics Precision Medicine role could be an exciting opportunity to...
-
PAXLOVID Customer Marketing Director
1 month ago
Collegeville, Pennsylvania, United States Pfizer Full timeROLE SUMMARYAt Pfizer (NYSE: PFE), we apply science and global resources to bring therapies to people that extend and significantly improve their lives. Every day, Pfizer colleagues work to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier...
-
Director Epidemiology
2 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeSite Name: Upper Providence, Belgium-Wavre, Mississauga, USA - Massachusetts - WalthamPosted Date: Aug Would you like to be part of GSK's Global Epidemiology, Vaccines team, with an opportunity to drive Epidemiology strategy and studies across the spectrum of vaccine development? If so, this is an excellent opportunity to explore.Job PurposeThe Director in...
-
Collegeville, Pennsylvania, United States Pfizer Full timeROLE SUMMARYThe Medical Director will provide leadership and expertise in Sickle Cell Disease (SCD) contributing to the planning and execution of medical strategies, technical expertise and an in-depth understanding of medicine development and lifecycle to bear on all US Medical SCD-related activities. This individual will be an integral member of the US...
-
Director, R&D Digital
3 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeSite Name: UK - London - New Oxford Street, USA - Pennsylvania - Upper ProvidencePosted Date: Aug Director, R&D Digital & Tech Portfolio - Financial Management, Analytics & InsightsGSK R&D and Digital & Tech's (RDDT) collective goal is to deliver GSK impact, including the acceleration the discovery and development of medicines and vaccines to patients. R&D...
-
Scientific Leader/Associate Director
4 weeks ago
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - Upper ProvidencePosted Date: Aug 8 2024Are you a scientist in sterile product formulation and injectables eager to lead the development of life-changing drug products? Are you eager to unite science, talent, and technology to get ahead of disease together? This may be the right opportunity for youAs a Scientific...
-
Director GU Account Marketing
1 month ago
Collegeville, Pennsylvania, United States Pfizer Full timeROLE SUMMARYThe GU Account Marketing Role will be responsible for developing and executing on account strategies for the entire GU (Bladder and prosteate) portfolio as well support late stage pipeline assets.The Director, US GU Account marketing position will lead marketing strategy specifically focused on organized providers and key accounts (i.e. IDNs,...
-
Collegeville, Pennsylvania, United States GlaxoSmithKline Full timeSite Name: Collegeville TSA, Belgium-Wavre, Canada - Ontario - Mississauga, USA - Massachusetts - Cambridge, USA - Massachusetts - WalthamPosted Date: Aug Would you like to be part of GSK's Global Epidemiology, Vaccines team, with an opportunity to drive Epidemiology strategy and studies across the spectrum of vaccine development? If so, this is an excellent...