Director/Team Lead, Clinical Pharmacology Modeling and Simulation
Site Name: UK - London - Brentford, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence Posted Date: Aug 19 2021 The Director/Team Lead, Clinical Pharmacology Modeling and Simulation at GlaxoSmithKline (GSK) is recruiting for a Director/Team Leader located in Collegeville, PA or Research Triangle Park, NC. Remote working may be considered for the right candidate. The position of Director/Team Leader, CPMS, represents a key opportunity for professionals with PhD, MD, PharmD or equivalent background, who are experienced and/or aspired to lead a team of clinical pharmacologists and pharmacometricians to advance the vision and mission of GSK's rapidly expanding Infectious Disease portfolio including Vaccines to prevent, treat and cure infectious diseases. In this role, you assume the scientific and managerial responsibility for a team of CPMS colleagues aligned to the Infectious Disease therapeutic area including Vaccines to ensure that projects and the R&D pipeline receive optimal clinical pharmacology and pharmacometric support. In particular, you will be expected to play a critical role in driving integration of end-to-end model-informed drug discovery and development. In addition, you will be accountable to define, coordinate and defend Clinical Pharmacology Modelling & Simulation development strategies at senior level meetings, and provide expert input into the clinical pharmacology evidence generation and integrated evidence plans in the Infectious Disease therapeutic area including Vaccines. CPMS responsibilities and accountabilities generally commence at candidate selection with preparations of first time in human trials, and continue through to filing, registration, and market expansion. Main responsibilities and accountabilities also include: Highly influential, define and execute a co-ordinated scientific and technical strategy (18-24 months planning horizon) with demonstrated ability to co-ordinate outputs from several expertise areas to determine strategy Establish or guide mathematical model development to understand disease, its progression, and drug action to prevent, treat and cure diseases; conduct meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performance Write or review and be accountable for clinical pharmacology components of regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology, modelling and simulation contents) Approval of design, analysis, interpretation, reporting and corresponding regulatory documents across a portfolio of programs that relate to clinical pharmacology modelling and simulation aspects Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline Ability to inspire CPMS staff, identify talent, provide appropriate coaching to ensure future leadership for the CPMS organization Ability to interact with line and middle management, staff and external contacts on a functional, strategic and tactical level Represent CPMS on various internal advisory boards, companywide initiatives and/or leadership teams Promote transparency and communicate R&D achievements through publications in appropriate scientific journals Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD, MD, or PharmD with 8 years + experience in clinical pharmacology, modeling and simulation in academia, regulatory agencies, and/or pharmaceutical research and development Substantial experience in clinical pharmacokinetics, modelling/simulation and drug development to solve practical problems in pharmaceutical industry Proven skills in pharmacokinetic-pharmacodynamic and model based meta-analysis; verifiable proficiency in pharmacometric tools such as NONMEM, Monolix, R or SAS Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results Knowledge of or ability to quickly learn the mechanism, endpoints, progression, prevention and treatments of Infectious Disease Experience managing teams and developing staff Preferred Qualifications: Prior experience in Vaccine Research and Development is a plus Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design Clear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks Experience working with senior stakeholders in a cross functional environment Strong track record of implementation of Model-Informed Drug Discovery and Development (MID3) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs 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, rigour and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritisation, execution, delivering performance. Setting strategic direction and leading on-going organisational transformation. *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). 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