Description:
Candidate with strong expertise in clinical pharmacology and pharmacokinetics (PK) to identify and evaluate drug candidates suitable for development via the 505(b)(2) regulatory pathway. The role focuses on leveraging existing clinical, safety, and efficacy data of approved products to propose differentiated formulations addressing unmet clinical needs.
Essential Functions:
- Identify potential drug molecules suitable for 505(b)(2) development based on scientific, clinical, and commercial rationale.
- Critically review published and regulatory data (PK, safety, efficacy, bioavailability) from approved products, literature, and databases.
- Assess clinical unmet needs and define opportunities for improved formulations (e.g., long-acting injectables, depot systems, novel delivery platforms).
- Propose formulation strategies aligned with pharmacokinetic and therapeutic objectives.
- Support development of clinical and regulatory strategies for 505(b)(2) submissions.
- Collaborate with formulation R&D, regulatory, and business teams to prioritize development candidates.
Prepare scientific justifications, gap analyses, and development proposals for internal decision-making.
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Additional Responsibilities:
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
