Manager / Senior Manager - Clinical Pharmacology

Bioplus Life Sciences; India; On-site; INR 1,600,000 - 2,100,000; Full time

Job summary

Bioplus Life Sciences is seeking a Manager/Senior Manager for Clinical Pharmacology to lead design of clinical pharmacology strategies and protocols across ophthalmology, hepatology, and autoimmune programs. The role focuses on translating preclinical findings into human trials and optimizing dosing for diverse patient populations.

You will collaborate with cross-functional teams to drive programs from Phase I through Phase IV and draft pharmacology sections for global regulatory submissions,

Qualifications

• Ph.D., Pharm.D., or M.D. in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline.
• 5–10 years of experience in a pharmaceutical company/global biotech with clinical protocol design.
• Lead clinical pharmacology strategy and protocol design across diverse therapeutic areas (ophthalmology, hepatology, autoimmune diseases).
• Translate preclinical findings into robust human clinical protocols and optimize dosing for special populations.
• Collaborate with cross-functional teams to advance the pipeline from Phase I through Phase IV.

Responsibilities

• Design and oversee Phase I–IV clinical pharmacology protocols with robust scientific framing.
• Apply PK/PD principles to dose selection and regimen optimization.
• Draft and review clinical pharmacology sections for regulatory submissions (IB, INDs, CSRs).
• Collaborate with operations, biostatistics, toxicology, and regulatory affairs across global sites.

Skills

Therapeutic familiarity

Regulatory insight

Communication

Education

Ph.D./MD/Pharm.D. in Clinical Pharmacology

Job description

Manager / Senior Manager - Clinical Pharmacology

Ph.D., Pharm.D., or M.D. in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related scientific discipline.

5–10 years of experience in pharmaceutical company/global biotechnology with clinical protocol design.

We are seeking a highly motivated Clinical Pharmacologist to join our global clinical development team based in Bangalore. In this role, you will lead the clinical pharmacology strategy and clinical trial protocol design across our diverse therapeutic pipeline, which spans ophthalmology, hepatology, and autoimmune diseases. You will translate preclinical findings into robust human clinical protocols, optimize dosing strategies for unique patient populations, and collaborate with cross-functional teams to advance our pipeline from Phase I through Phase IV

Key Responsibilities

• Protocol Design & Strategy: Lead the clinical pharmacology design of Phase I–IV clinical trial protocols, ensuring rigorous scientific frameworks for first-in-human, drug-drug interaction, and special population studies
• Therapeutic Application: Apply targeted clinical pharmacology principles unique to our core therapeutic areas, including ocular drug delivery kinetics, liver impairment dosing adjustments, and small molecule dynamics in autoimmune conditions
• PK/PD Input: Collaborate with quantitative modelling teams to interpret pharmacokinetic (PK) and pharmacodynamic (PD) data to establish clear proof-of-concept and justify dose selection
• Regulatory Authoring: Draft and review clinical pharmacology sections of vital global regulatory submissions, including Investigator’s Brochures (IB), Investigational New Drug (IND) applications, and clinical study reports
• Cross-Functional Collaboration: Act as the core clinical pharmacology representative on multidisciplinary project teams, aligning strategies with clinical operations, biostatistics, toxicology, and regulatory affairs across global sites
• Biomarker Integration: Partner with translational medicine to incorporate safety, efficacy, and imaging biomarkers (such as ocular imaging or liver stiffness metrics) into clinical trial designs

Skills and Competencies

• Therapeutic Familiarity: Practical experience or strong foundational knowledge working within ophthalmology (e.g., intravitreal/topical kinetics), hepatology (e.g., MASH/NASH, hepatic impairment), or immunology/autoimmune diseases
• Regulatory Insight: Thorough understanding of global regulatory mandates (FDA, EMA, and ICH regulations), particularly guidelines concerning drug development, safety, and dosing in special populations
• Communication: Exceptional technical writing and Englishcommunication skills, with the ability to clearly articulate clinical pharmacology strategies to both scientific and operational stakeholders globally

Preferred Skills

• Experience managing clinical pharmacology studies for either small molecule or biologics (e.g., monoclonal antibodies)
• Familiarity with the operational challenges of complex clinical trials, including patient recruitment and specialized clinical site requirements