- As part of the R&D development team, you will provide expertise to the overall pre-clinical and clinical development of novel biologics, in particular the design and oversight over clinical pharmacology.
- Provide input into clinical development plans, clinical study protocols and reports, Investigators Brochures and the pharmacology section of INDs and CTAs
- Interact with regulatory agencies (US and ex-US) as needed.
- You will be accountable for all clinical pharmacology aspects of compounds in the discovery to early development stage.
- You will be responsible for oversight and interaction with consultants and CROs assigned to support clinical pharmacology tasks including preclinical PK, modeling, and clinical assay development.
- PhD or PharmD required.
- >5 years of experience in Clinical Pharmacology supporting early development of biologics in a biotech or pharmaceutical organization.
- clinical pharmacology experience with biologics in oncology is required.
- with regulatory submissions and responses in early development is required.
- with model-informed drug development preferred.
- working on T-cell based therapeutics, particularly multi-specific T-cell engagers is preferred.
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Clinical Pharmacology Leader - Philadelphia, United States - Christine Mathews Consulting, a OneDigital Company
Description
**Remote, Hybrid or onsite Philadelphia, PA**
Company Background:
Stealth, VC-backed, discovery-stage biotech company with significant funding focused on discovery and development of breakthrough biologics in Oncology and Immunology. This small but experienced team is currently expanding headcount to support the next phase of growth through IND submissions and clinical development.
Position Summary:
As Clinical Pharmacology Lead, you work in our early development teams on novel biologics, with a responsibility for the ClinPharm package, connecting the project from discovery and preclinical PK into FIH studies. In this role, you will support IND preparation, work with the clinical team to set first in human dosing strategies, and continue with the teams into early development to support clinical PK/PD and optimal dose selection.
Essential Functions:
Experience:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity/expression, national origin, disability, medical condition, age, marital status, status as a protected veteran, or any other legally protected characteristic.
