Clinical Pharmacologist
13 hours ago
Design, plan, and oversee clinical pharmacology studies (Phase I–IV).
Develop protocols for PK/PD, dose-ranging, bioavailability, and drug interaction studies.
Contribute to modeling and simulation strategies to optimize dosage regimens.
Perform and interpret PK/PD analyses using population modeling software (e.g., NONMEM, Phoenix WinNonlin).
Evaluate drug exposure, safety, and efficacy relationships.
Prepare reports, manuscripts, and scientific presentations based on study results.
Support preparation of regulatory submissions (IND, NDA, BLA, CTD modules).
Provide responses to regulatory agencies and participate in meetings (FDA, EMA, MHRA, etc.).
Ensure studies comply with GCP, ICH guidelines, and institutional policies.
Work closely with clinical development, biostatistics, toxicology, medical affairs, and regulatory teams.
Provide clinical pharmacology expertise during trial planning and execution.
Contribute to benefit-risk assessments and labeling recommendations.
Evaluate pharmacological properties of investigational and marketed drugs.
Provide scientific insight on drug mechanism, metabolism, interactions, and safety profile.
Assess emerging literature and technologies relevant to clinical pharmacology.
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Clinical Pharmacologist
18 hours ago
Pune, India Bitwise Solutions Full timedesigning and carrying out experiments, including tests on cells, animals and human volunteers - making recommendations based on findings from research and experiments - laboratory and staff management - keeping up to date with research - carrying out research and writing papers for publication in specialist journals - collaborating with and sharing...
