Primary Responsibilities:
- Provide clinical expertise for identification/validation of novel targets; design preclinical/clinical experiments to validate targets/pathways; leverage for novel therapeutics development.
- Work with cross-functional teams (discovery scientists, pharmacologists, toxicologists, specialists) to advance therapeutics from preclinical to clinical development.
- Lead early development team; collaborate with internal/external staff (biostatistics, drug metabolism, modeling/simulation, regulatory affairs, global clinical trials operations) to design and execute early clinical development strategy.
- Develop and execute clinical pharmacology studies across phases IβIV, including formulation/device changes, drugβdrug interaction studies, and special populations.
- Provide early phase/clinical pharmacology support through regulatory filing (supportive documents and presentations).
- Validate clinical biomarkers (blood/tissue sampling, imaging, electrophysiology, wearable devices, behavioral responses) to assess biological activity in humans.
- Provide clinical/scientific expertise to assess partnership opportunities.
- Engage with scientific community (consultations, posters/publications, conferences).
- Work with company functions at global research sites.
Translational Medicine Responsibilities:
- Identify novel targets via partnership with Discovery Sciences; execute clinical studies to evaluate relevance to human disease.
- Lead early clinical development strategy from preclinical to Phase 1 (safety, tolerability, PK/PD) and Phase 2 (Proof-of-Concept) through enabling Phase 3 trials.
- Develop biomarker strategies and experimental medicine studies to establish/validate biomarker platforms.
- Develop/execute clinical pharmacology strategies supporting later stages and worldwide regulatory applications.
Education:
- MD or MD/PhD (or international equivalent) required.
Required:
- Biomedical research experience with demonstrated scientific scholarship and publications.
- Strong interpersonal, writing, and presentation skills; collaborative team environment.
- Clinical medicine experience: completion or anticipated completion of residency and fellowship.
- Pulmonology fellowship training and clinical board certification (or related respiratory discipline such as Allergy) required.
Preferred:
- Academic faculty experience.
- Prior pharmaceutical industry experience (helpful, not required).