Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Mar 3 2020
The position of Senior Director Quantitative Clinical Pharmacology represents a key opportunity for professionals with PhD, MD, PharmD or equivalent background, who have a strong track record in oncology drug development, are strongly motivated and have good understanding of the scientific, clinical, operational and regulatory aspects of oncology drug development. GSK Oncology R&D is expanding rapidly, and GSK oncology is committed to the discovery and development of new oncology therapies that leverage patient-driven science to deliver improved outcomes for more patients.
Clinical Pharmacology Modelling and Simulation (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.
In this role you assume responsibility for a team of CPMS colleagues aligned to the Oncology therapeutic area 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 development. In addition, you will be accountable to define, coordinate and defend Clinical Pharmacology Modelling & Simulation (CPMS) development strategies at senior level meetings, and provide expert input into the clinical pharmacology evidence generation and integrated evidence plans in the Oncology therapeutic area.
Main responsibilities and accountabilities also include:
Highly influential, define and execute a co-ordinated scientific and/or technical strategy (18-24 months planning horizon) with demonstrated ability to co-ordinate outputs from several expertise areas to determine strategy.
Thorough understanding and ability to apply appropriate FDA, EMA and ICH guidelines in the design of clinical studies and drug development strategy.
Review and write clinical pharmacology components of all regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology contents).
Approval of design, analysis, interpretation, reporting and corresponding regulatory documents across a portfolio of programs that relate to clinical pharmacology and pharmacometric aspects.
Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology contribution 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
We are looking for professionals with these required skills to achieve our goals:
PhD or MD with > 10 year experience in quantitative clinical pharmacology
Experience with managing teams and developing staff
Significant experience in oncology clinical pharmacology and pharmacometrics gained within the pharmaceutical industry
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.
If you have the following characteristics, it would be a plus:
Prior experience with regulatory submissions and regulatory interaction in oncology novel therapeutics such as cell-therapy and novel modalities
Working knowledge and good understanding of quantitative methods using in oncology drug development
Excellent (written and oral) communication skills
Project experience working in a matrix environment
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.
Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.Managing P&L and capital allocation.
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