DMPK Project Specialist
Site Name: UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware RD, USA - Pennsylvania - Upper Providence Posted Date: Mar 2 2021 The role of the DMPK project specialist is both critical and visible within and outside the DMPK organization being the face of DMPK on multifunctional project teams. In addition to providing scientific leadership to project teams, DMPK project specialists are essential for shaping the direction of DMPK science to ensure that innovation is aligned with portfolio deliverables. They are also critical in the mentoring and development of DMPK staff as part of succession planning as well as strengthening the links between groups outside DMPK with subject matter experts (SMEs) within the department. Job purpose and key responsibilities: Establish and implement innovative DMPK strategy to projects as an active and engaged member in integrated multifunctional project teams and/or project sponsored sub teams responsible for the development of new therapeutics across modalities from early discovery to market. Represent project DMPK science at R&D governance, review boards and externally with regulatory authorities. Provide single point of accountability for DMPK including delivery, integration and interpretation of ADME/PK and PK/PD data for small molecules, protein and antibodies. Design and implement innovative DMPK project strategy; guidance on optimal DMPK properties and screening approaches in relation to the desired product profile/target population/disease indication with a focus on risk identification, iterative lead optimization, candidate quality and reduction of late stage attrition. Integrate DMPK data and knowledge into quality narratives to support robust, evidence based internal decision-making across broad and often incomplete data sets. Work with modelling experts to build and apply PBPK models, communicate the assumptions, limitations, meaning and impact of mechanistic PK models to project teams and use routine modelling as a tool to generate hypotheses, design better studies, and inform projects through sensitivity analyses. Apply and interpret QSAR and in vitro models and work closely with Medicinal Chemistry and Biopharm Discovery to deliver optimal tool and quality candidate molecules. Work closely with modelling experts, biology and QSP experts to deliver PKPD and dose prediction packages. Review and provide DMPK contributions to regulatory documents. In collaboration with global DMPK, ensure that technologies and science are relevant for project team and portfolio deliverables. Provide mentorship to facilitate succession planning and development of staff in functional lines across DMPK. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors degree or equivalent. Any general science degree e.g. life science, medicine, clinical research, pharmacy etc. At least 5 years' experience of the application of DMPK science and strategy in drug discovery and development environment for NCEs and/or biopharm is necessary for deep expertise in a specific area of DMPK science together with the broader application of DMPK knowledge and strategic awareness to provide the level of scientific leadership and mentoring required. Has broad knowledge of related scientific disciplines with demostrated ability to influence drug Discovery or Development efforts inside of DMPK. Proven track record of providing mentoring and coaching to develop staff A strong understanding of protein therapeutics, pharmacokinetics and PK/PD modeling Stakeholder management skills required as the role includes interactions with senior stakeholders at a central or LOC level. Strong written and verbal communications skills are required in English and local language. Preferred Qualifications: If you have the following characteristics, it would be a plus: PhD degree in a science related field or equivalent 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: Confidence in working in an environment that is constantly evolving with new processes, tools and systems, internally and externally. Contributes to creating solutions to manage study/program challenges and opportunities; suggests new ways to apply existing knowledge. Recognizes and reacts to changes that impact a study and/or program or practices. Demonstrates track record in quality decision-making and problem resolution that impacts study/program direction. Understands and effectively utilizes change management tools and approaches. Role requires working in a highly matrixed environment with internal and external customers both regionally and globally based. Utilize negotiation skills internally and externally to ensure maximum value from vendors across studies and/or programs. 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