GSK

Scientific Investigator, Safety Pharmacology

Employer
GSK
Location
Collegeville, PA
Salary
Competitive
Posted
April 29 2021
Ref
281500
Organization Type
Pharma
Are you looking for a role where you will provide specialized scientific and translational expertise for drug discovery and development? If so, this, Scientific Investigator role could be an ideal opportunity to explore.

The Safety Pharmacology group in Non-Clinical Safety, In Vitro/In Vivo Translation is a multi-site resource focused on the proactive management of safety pharmacology issues and their translation to man. Safety Pharmacology supports all therapeutic areas from idea to loss of exclusivity including experimental approaches to aid target and compound selection, regulatory pre-FIH safety studies and post-FIH investigative studies to address clinical findings and manage risk. The broad remit of the department requires strong discipline expertise and a clear and strong interface with the portfolio.

This position is an exciting opportunity to make a difference in the lives of patients by applying human physiology and pharmacology expertise coupled with translational knowledge and industry experience to drive drug discovery and development.

As a Scientific Investigator, you will be responsible for conducting and summarizing safety studies on new drug substances, including regulatory input. You will also help manage non-clinical safety strategies and programs across the function.

Key Responsibilities:
  • This individual will be based in Upper Providence, PA, USA and will work within the general safety pharmacology discipline.
  • Overall responsibility for the technical conduct of the Safety Pharmacology study, as well as for, the interpretation, analysis, documentation and reporting of results (including SP endpoints in General Toxicology studies) and represents the single point of study control (study monitor/study director).
  • The role is for a subject matter expert in human physiology, pharmacology or toxicology with an emphasis on safety pharmacology.
  • The role will be part lab based and will require the design, conduct and interpretation of in vitro and in-vivo studies to support the safety pharmacology assessment of projects across the portfolio.
  • Provide strategic advice, implementing de-risking strategies and influencing partners.
  • Use the scientific literature and available in-house data to design and interpret studies.
  • Engage in the discussion and interpretation of data beyond their own discipline. This will include working with subject matter experts in other disciplines including those in safety pharmacology i.e. CV, CNS, Respiratory, ion channels and in vitro pharmacology as well as other specialties.
  • Prepare study protocols, reports, amendments, and deviations in accordance with all applicable laws and regulations including, but not limited to, Good Laboratory Practices (GLPs; 21 CFR Part 58), Institutional Animal Care and Use Committee (IACUC) guidelines, Regulatory Agency guidelines and regulations, and departmental Standard Operating Procedures.
  • Serve as Study Monitor for studies conducted at Contract Research Organizations, including those to support the FTIH milestone, ensure studies meet GSK guidelines and keep to specified timelines.
  • Additional duties may include project team membership, contributions to development of capabilities, and interacting with strategically aligned public private partnerships.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • A PhD, preferably in pharmacology, physiology or a related biological discipline
  • Experience in pharmacology or physiology research with applications in drug discovery
  • Experience working in a matrix environment, working across functions/disciplines
  • Experience in the integration of large data sets from multiple sources, to develop and communicate an understanding of the issue and associated risk
  • Experience of mentoring/coaching junior colleagues
  • Experience interacting with external partners (e.g. CROs, academic groups)


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Two years of post-doctoral or industrial experience
  • Expertise and experience in the CNS or neuroscience area
  • Experience inthe design, conduct and interpretation of in vitro neurophysiological assays and in vivo CNS behavioral and Neurophysiology models
  • Evidence of broad knowledge of drug delivery, ADME, pharmacology, toxicology and translational sciences.
  • Experience building and using Quantitative Systems Pharmacology/Toxicology (QSP/QST) models.
  • Experience in numerical analysis and applying mechanism based mathematical modeling techniques.
  • Experience in influencing decisions and experimental design by using appropriate modeling approaches that integrate all available data.
  • Evidence of identifying, developing, and applying innovative solutions to scientific and technological problems including, Automated Neurobehavioral Systems, Complex In Vitro Models and Microphysiological Systems.
  • Experience of working as part of discovery project teams, and experience of incorporating a drug safety strategy into a project strategy.


Why GSK?

Our values and expectationsare 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
  • 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.
  • Budgeting and forecasting, commercial and financial acumen.


*LI-GSK

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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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