Scientific Leader
GSK
4 hours ago
Remote friendly (Collegeville, PA)
United States
Clinical Research and Development
Key Accountabilities / Responsibilities:
- Lead design and execution of in vivo strategy for preclinical projects (and potentially clinical programs) for renal and liver diseases.
- Design, execute, analyze, interpret, and present preclinical PK/PD, efficacy, and mechanistic in vivo studies using translational biomarkers and robust study design across R&D phases.
- Provide independent scientific rationale, objectives, implementation, endpoints, and Go/No-Go decisions for in vivo studies.
- Serve as In Vivo Leader (IVL) on portfolio projects; coordinate with Biology Leader, Project Leader, Complex Models Leadership Team, and partners; may guide other in vivo team members.
- Oversee external CRO/academic in vivo studies as study monitor; ensure accurate reporting to stakeholders and leadership.
- Lead in vivo strategy and apply RSD principles; incorporate input from SMEs/matrix partners (e.g., Statistics, PK modeling, Histopathology, Biopharm, Chemistry) prior to ISR/PSB animal-study endorsement.
- Incorporate novel models/technologies and biomarkers; select in vivo models using omics datasets.
- Resolve technical issues in planning, timelines, setup, and execution; identify bottlenecks.
- Execute lab/vivarium studies enabling sample/tissue acquisition and integration of PK/PD with translational biomarker data.
- Act as key contact for animal studies (including out-of-hours procedures as required).
- Maintain expertise in rodent handling, dosing, blood/tissue collection, and physiologic measurements.
- Comply with animal research regulations and governance (IACUC/ISR); adhere to severity/adverse effect constraints and animal care/welfare policies.
- Ensure animal health/welfare assessments, documentation, and corrective actions.
- Collaborate with internal matrix partners and external collaborators; lead study monitoring.
- Communicate in vivo strategy and study results verbally and in writing; maintain compliant electronic lab records (data integrity, SOPs, risk assessments, safety).
- Read scientific literature and apply it to in vivo biology strategy and studies.
Required Qualifications / Skills:
- Master’s in physiology/pharmacology/biology/immunology with 5+ years in vivo experience, or PhD with 3+ years in vivo experience (industry or academic).
- Lab/vivarium experience with animal model systems in renal and/or liver disease.
- Knowledge of renal/liver physiology and pathophysiology; metabolically aligned disease pathways; biomarker strategy.
- Application of pharmacology principles in early drug discovery.
- Independent analysis of complex in vivo/ex vivo/in vitro data.
- Experience with robust study design (RSD) and writing/critiquing protocols.
- Rodent handling, dosing, necropsy, blood sampling; familiarity with IT systems (e.g., Tick@Lab, eLN, PACT).
- Experience with statistical and data visualization software (e.g., GraphPad Prism, Spotfire).
Preferred Qualifications:
- Experience leading biology or preclinical discovery projects.
- Strong problem-solving during planning and in-life study phases.
- Ability to work independently and collaboratively.
- Experience overseeing external animal studies as Study Monitor.
- Ability to write/critique scientific documents and clearly communicate findings (Microsoft Office, Teams, SharePoint).
- Adaptability to manage multiple studies.
- Awareness and application of risk assessments/SOPs and local safety practices.
- Demonstrated learning agility.
- Lead design and execution of in vivo strategy for preclinical projects (and potentially clinical programs) for renal and liver diseases.
- Design, execute, analyze, interpret, and present preclinical PK/PD, efficacy, and mechanistic in vivo studies using translational biomarkers and robust study design across R&D phases.
- Provide independent scientific rationale, objectives, implementation, endpoints, and Go/No-Go decisions for in vivo studies.
- Serve as In Vivo Leader (IVL) on portfolio projects; coordinate with Biology Leader, Project Leader, Complex Models Leadership Team, and partners; may guide other in vivo team members.
- Oversee external CRO/academic in vivo studies as study monitor; ensure accurate reporting to stakeholders and leadership.
- Lead in vivo strategy and apply RSD principles; incorporate input from SMEs/matrix partners (e.g., Statistics, PK modeling, Histopathology, Biopharm, Chemistry) prior to ISR/PSB animal-study endorsement.
- Incorporate novel models/technologies and biomarkers; select in vivo models using omics datasets.
- Resolve technical issues in planning, timelines, setup, and execution; identify bottlenecks.
- Execute lab/vivarium studies enabling sample/tissue acquisition and integration of PK/PD with translational biomarker data.
- Act as key contact for animal studies (including out-of-hours procedures as required).
- Maintain expertise in rodent handling, dosing, blood/tissue collection, and physiologic measurements.
- Comply with animal research regulations and governance (IACUC/ISR); adhere to severity/adverse effect constraints and animal care/welfare policies.
- Ensure animal health/welfare assessments, documentation, and corrective actions.
- Collaborate with internal matrix partners and external collaborators; lead study monitoring.
- Communicate in vivo strategy and study results verbally and in writing; maintain compliant electronic lab records (data integrity, SOPs, risk assessments, safety).
- Read scientific literature and apply it to in vivo biology strategy and studies.
Required Qualifications / Skills:
- Master’s in physiology/pharmacology/biology/immunology with 5+ years in vivo experience, or PhD with 3+ years in vivo experience (industry or academic).
- Lab/vivarium experience with animal model systems in renal and/or liver disease.
- Knowledge of renal/liver physiology and pathophysiology; metabolically aligned disease pathways; biomarker strategy.
- Application of pharmacology principles in early drug discovery.
- Independent analysis of complex in vivo/ex vivo/in vitro data.
- Experience with robust study design (RSD) and writing/critiquing protocols.
- Rodent handling, dosing, necropsy, blood sampling; familiarity with IT systems (e.g., Tick@Lab, eLN, PACT).
- Experience with statistical and data visualization software (e.g., GraphPad Prism, Spotfire).
Preferred Qualifications:
- Experience leading biology or preclinical discovery projects.
- Strong problem-solving during planning and in-life study phases.
- Ability to work independently and collaboratively.
- Experience overseeing external animal studies as Study Monitor.
- Ability to write/critique scientific documents and clearly communicate findings (Microsoft Office, Teams, SharePoint).
- Adaptability to manage multiple studies.
- Awareness and application of risk assessments/SOPs and local safety practices.
- Demonstrated learning agility.