Vice President

Urgent Requirement for a reputed Pharma group Manufacturing Formulations -OSD unit (MHRA ,TGA& other Regulatory approved facility) with established R&D

Location : Bangalore

Vice President - Clinical Strategy (Discovery)

Qualification : MD /Pharmacology / General Medicine Or M.Pharma PhD with Pharmacology

POSITION SUMMARY:

Our organization seeks an MD in Pharmacology to lead global clinical strategy and development for its pipeline of novel biopharmaceuticals and complex biosimilars, including a Phase 3 NDA for pediatric myopia, a Phase 2 candidate for MASH (metabolic dysfunction-associated steatohepatitis), and a Phase 3 asset for preterm birth prevention. This role requires designing end-to-end clinical development plans, coordinating with global regulatory agencies (FDA, EMA, MHRA), and driving cross-functional alignment with CROs, drug discovery teams, and internal stakeholders to achieve successful approvals.

KEY RESPONSIBILITIES:

Clinical Strategy & Development Planning

- Design global clinical development strategies for 14+ preclinical/clinical assets, including Phase 3 NDAs and biosimilars, aligning with regulatory and commercial objectives.

- Lead protocol development for pivotal trials, ensuring robust study designs (endpoints, patient populations, adaptive methodologies) to meet US FDA, EMA, and ICH guidelines.

- Collaborate with executive leadership (e.g., R&D, medical affairs, regulation, formaltion) to ensure integrated planning.

- Identify opportunities for innovation in trial design, biomarkers, or patient recruitment strategies.

- Coordinate with external stakeholders such as CROs, KOLs (Key Opinion Leaders), and clinical investigators.

- Develop go/no-go decision frameworks for clinical programs based on data-driven insights.

Regulatory Coordination

- Serve as primary liaison with global health authorities, preparing INDs, NDAs, and MAAs. Lead pre-submission meetings, address queries.

- Oversee responses to regulatory inspections and audits, ensuring compliance with GCP, 21 CFR part 11, and ICH E6(R3).

Data management and Biostatistics

- Collaborate with data science and biostatistics teams to define endpoints, statistical analysis plans, and data strategy.

- Guide the use of predictive analytics and machine learning in trial optimization.

- Monitor and interpret data readouts to adjust strategy and inform key decisions.

- Align on endpoint selection, statistical analysis plans, and interim analyses.

Cross-Functional Leadership

- Collaborate with Drug Discovery and CROs to translate preclinical data into clinical trial frameworks.

- Partner with Biostatistics, Medical Affairs, and Safety teams to analyze trial data, mitigate risks, and support DSMB Focus

- Pediatric Myopia (Phase 3): Finalize NDA strategy, including long-term safety studies and pediatric investigation plans (PIPs).

- MASH (Phase 2): Optimize trial designs for biomarkers, histopathology endpoints, and dose-ranging studies.

- Preterm Birth Prevention (Phase 3): Lead multinational trials, addressing regional recruitment challenges and regulatory variances.

Team & Budget Management

- Oversee clinical budgets and timelines.

- Oversee vendor contracts, and resource allocation across programs.

- Ensure timely execution of projects within budget Education: MD in Pharmacology/Medicine or related field; board certification preferred.

Experience:

15+ years in clinical development, including 5+ years in leadership roles at biopharmaceutical companies.

Proven success in global NDA/MAA submissions (FDA/EMA) for biologics/biosimilars.

Expertise in ophthalmology, metabolic disorders, or maternal-fetal therapeutics.

Skills:

Mastery of adaptive trial designs, real-world evidence integration, and digital endpoints.

Fluency in clinical trial software (Medidata Rave, Veeva) and regulatory platforms (eCTD).