Clinical Director; Principal Scientist), Translational Medicine, Immunology

Overview

Job Description

Translational Medicine leads early clinical development of novel therapeutics, collaborating with Immunology Discovery Sciences and late-stage Immunology Clinical Research. The role focuses on Immunology and requires a strong background in basic and/or clinical translational research with the ability to collaborate across therapeutic areas.

Key responsibilities of Translational Medicine

• Lead the early clinical development strategy for novel therapy programs from Preclinical Candidate approval through Clinical Pharmacology testing (Phase
  1) and clinical Proof-of-Concept (Phase
  2).
• Develop biomarker strategies with cross-functional teams to provide line-of-sight from First-in-Human studies through clinical Proof-of-Concept, including Experimental Medicine studies to establish and/or validate biomarker platforms.
• Contribute to identification of novel targets by partnering with discovery research teams to bring a clinical perspective to early target identification and validation and to execute clinical studies evaluating relevance to human disease to justify investment in clinical development.
• Develop and execute clinical pharmacology strategies to support later development from Proof-of-Concept (Phase
  2) through worldwide marketing applications.

Environment and collaboration

Success depends on integrity, knowledge, imagination, creativity, skill, and teamwork. The team collaborates with Translational Medicine, Discovery Sciences, and late-stage Clinical Research, while developing and expanding individual careers.

• Be a key member of an early development team, providing leadership in designing and executing early clinical development strategy.
• Develop and execute early clinical strategy for novel therapeutics, including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical Candidate molecules, and clinical pharmacology studies for Phases I–IV.
• Design studies to validate clinical platforms using established and novel biomarkers, including imaging, electrophysiological, and behavioral measures to interrogate biological activity in humans.
• Provide clinical expertise for identification and validation of novel targets, including designing preclinical and/or clinical pharmacology experiments to validate targets and/or pathways.
• Ensure safe and timely execution of Phase I studies with collaboration across internal and external study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations).
• Provide clinical pharmacology support for programs through worldwide regulatory filing, including supportive registration documents and presentations.
• Communicate and interpret study results clearly and timely to therapeutic area governance, functional area experts, and development review committees.
• Contribute to assessment of internal and external opportunities identified by Business Development and Licensing.
• Interface broadly with key functions across the organization throughout research sites worldwide, including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research.

• MD or MD/PhD

• Required: Proven track record in clinical medicine or clinical research, with a background in biomedical research.
• Demonstrated record of scientific scholarship and achievement including publications or presentations. The clinical or scientific background is less important than a track record of excellence and collaboration across therapeutic areas.
• Strong interpersonal, writing, and presentation skills; ability to function effectively in a team environment.

• Clinical Board Certification or Eligibility.
• Prior experience in translational research and/or early clinical development preferred but not required.
• Proven track record in clinical care of patient populations or management of clinical problem-solving.

Clinical Development, Clinical Judgment, Clinical Research, Clinical Studies, Clinical Trials, Clinical Trial Support, Cross-Functional Teamwork, Early Clinical Development, Immunology, Intellectual Curiosity, Translational Medicine, Translational Research

Current Employees apply through internal channels. Current Contingent Workers apply through internal channels.

We are an Equal Employment Opportunity Employer. We comply with federal requirements and provide equal opportunities regardless of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or other legally protected characteristics. We offer a comprehensive benefits package including medical, dental, vision, retirement…