Senior Manager - Clinical Pharmacology & Pharmacokinetics

Opportunity with a leading Global Pharma MNC for a Senior Manager, Clinical Pharmacology & Pharmacokinetics based in Mumbai(Only female candidates)

Primary Job Function:

Responsible for designing and providing oversight of clinical research programs for various compounds in compliance with applicable laws, regulatory guidelines, quality standards and company policies. Build relationships with internal and external stakeholders towards development of an overall clinical strategy. Ensure that all clinical development work assigned is carried out in a timely manner with the required quality.

Core Job Responsibilities:

- Develop state of the art clinical development programs for various compounds in compliance with applicable laws, regulatory guidelines, quality standards and company policies.

- Planning and execution of BE (Bioequivalence) studies & patient-based PK study. Literature search for clinical studies and accordingly provides Pharmacokinetic and clinical inputs in protocol.

- NCA analysis by using Phoenix WinNonlin- software to generate PK & Statistical result table along with Mean & Individual graphs

- Responsible for handling phase I studies for BE, BA, PK, PD, safety, DDI, Food Interaction, Special Populations, Late Phase Clinical Pharmacology, Biowaiver wring etc.

- Provide overall clinical development strategy and requirements for various global studies. Responsible for study protocols, investigator's brochure, study reports, data interpretation and reporting.

- Plan, organize, coordinate and supervise clinical trials in accordance with the applicable regulations, within timing and budget with the help of internal and external partners.

- Product dossier preparation and support for various countries. Contribute in development of new formulations, modification of formulation, compound profiling, due diligence activities for future licensing.

- Support evaluation and selection of contract organizations (CROs) for outsourced studies.

- Provides strategic input to organization for publications, presentations, investigator meetings and other public forums in which clinical data is presented or interpreted.

- Interface with regulatory authorities directly as appropriate (e.g. FDA and EMA scientific advice meetings). Contribute the clinical modules in the product dossier preparation. Provide answers and further explanation to regulatory authorities.

- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

- Performs other related duties and responsibilities, on occasion, as assigned

CTC not a constraint for the right candidate

Only FEMALE CANDIDATES can apply