Manager Clinical Pharmacology Modelling and Simulation (CPMS)

Collegeville, Pennsylvania; Waltham, Massachusetts; Research Triangle Park, North Carolina
August 27 2021
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Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Massachusetts - Waltham, USA - North Carolina - Research Triangle Park Posted Date: Aug 27 2021 Are you energized by leveraging your advanced quantitative modeling skills to accelerate the development of medicines? 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. We also value the diversity of skills and experiences that each of us bring and thus are flexible with respect to the degree of focus. We are now looking for candidates with advanced M&S (pharmacometric) skills who have an appetite to apply these skills, drive M&S innovation and, if desired, develop into the clinical pharmacology role. 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. 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 locations. 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 quantitative clinical development program, robust registration package and support life cycle management of assets 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 later studies and 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 the CPMS strategy and discuss outcome of model-based approaches via interactions with project teams, 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 Advocate for the use of model-informed drug discovery and development (MID3) in teams and 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 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: development team leaders, 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 training with a degree such as PhD, PharmD and MD in Pharmaceutical Sciences, (Bio)Engineering, Mathematics, Statistics, Medicine or related field Minimum of 2 years post-graduation experience in a fellowship or industry environment Two or more years experience applying pharmacokinetic and pharmacodynamic principles and commonly applied pharmacometric models Two or more years experience utilizing tools for quantitative clinical pharmacology such as NONMEM, R, Monolix, SAS and/or MATLAB Preferred Qualifications: 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 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 Demonstrated expertise in a specific technical area, and/or oncology disease area Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results Why GSK? 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, rigor 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 collaboration, managing trusted stakeholder relationships internally and externally. *LI-GSK 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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