Designs and conducts PK studies for drug candidates in preclinical models. Analyses plasma, tissue, and urine samples for drug and metabolite concentration. Calculates PK parameters including Cmax, AUC, t1/2, and clearance values. Develops PBPK and PK/PD models to support dosing and development decisions. Coordinates with in-vivo pharmacology team for PK study conduct. Prepares PK reports and contributes to regulatory IND, ANDA, and NDA submissions. Supports clinical pharmacology study design and clinical PK data interpretation. Manages bioanalytical method development and validation for PK studies. Reviews bioequivalence study data and prepares regulatory assessments. Contributes to population PK and exposure-response analysis for drug programs. Evaluates drug-drug interaction potential using in-vitro CYP and transporter data. Provides PK expertise during FDA and regulatory agency scientific discussions. Stays updated with FDA guidance on PK, PBPK, and bioequivalence studies.

Monitors clinical trial sites to ensure compliance with ICH-GCP guidelines. Conducts site initiation visits, routine monitoring visits, and close-out visits. Reviews source documents and case report forms for accuracy and completeness. Identifies and resolves protocol deviations and data discrepancies at sites. Maintains accurate monitoring visit reports and site communication logs. Ensures informed consent process is properly conducted at all study sites. Manages investigational product accountability and temperature records. Coordinates with principal investigators and site staff for study conduct. Tracks patient enrollment and ensures recruitment targets are met on time. Manages trial master file (TMF) and ensures inspection readiness at all times. Supports serious adverse event (SAE) reporting and safety data management. Prepares escalation reports for protocol violations and major deviations. Stays updated with ICH E6 R2, CDSCO CT rules, and regulatory requirements.

Manages a team of medical representatives across an assigned region. Achieves regional sales targets and market share objectives. Conducts field work with MRs for coaching and performance improvement. Monitors doctor coverage, call frequency, and prescription trends. Identifies and develops key accounts and high prescriber relationships. Analyzes regional sales data and prepares performance dashboards. Manages distribution network including stockists and C&F agents. Coordinates CME programs and product promotional activities. Hires, trains, and appraises medical representative team members. Implements company strategies and campaigns at regional level. Manages regional budget including expenses and promotional spend. Reports market insights and competitor intelligence to management. Ensures ethical promotion aligned with company standards and regulations.

Position: Clinical Research Manager-Breast Medicine Our firm seeks a competent and professional Clinical Research Manager-Breast Medicine for a critical role in a high-performance environment. This position offers the opportunity to work with a diverse, cross-functional team in a results-oriented culture. Role Responsibilities: Develop SOPs, work instructions, and training materials for clinical operations teams. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Education and Experience Requirements: Minimum 35 years of progressive professional experience in a comparable role. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Experience collaborating within cross-functional teams and matrix organisational structures. Excellent verbal and written communication skills; fluency in English is essential. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. High degree of professionalism, integrity, and alignment with organisational values. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Candidates who meet the above requirements are encouraged to submit their detailed CV at the earliest opportunity.

Position: Clinical Data Manager Our organisation is looking for an ambitious Clinical Data Manager committed to quality outcomes and sustained growth. This is an opportunity to be part of a purpose-driven team reshaping industry standards and best practices. Primary Duties and Responsibilities: Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Provide clinical site training on data collection standards and regulatory requirements. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Develop SOPs, work instructions, and training materials for clinical operations teams. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Review source data and ensure completeness, accuracy, and regulatory compliance. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Required Qualifications: Strong interpersonal and stakeholder management skills with a client-service orientation. Commitment to ongoing professional learning and industry knowledge enhancement. Proficiency in relevant software and digital tools specific to the functional area. Ability to work both independently and in a team-oriented, collaborative environment. Detail-oriented mindset with the ability to synthesise and present complex information clearly. Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We value talent and invest in our people this role offers both professional challenge and meaningful rewards.