Company Description:

With over 78 years of experience, Bioplus Life Sciences is a pharmaceutical company based in Bengaluru. We focus on advanced Biotechnology and have programs in late-stage clinical phases for global unmet needs. Our pipeline includes pre-clinical programs and blockbuster Novel therapeutics, with a strong emphasis on R&D and Clinical Development.

We are delighted to invite you to explore an opportunity of learning, contributing and discovering science and medicine with us as part of our global research team. Bioplus Life Sciences and its affiliate Theialife Inc, USA & Akeso Biopharma, Singapore have a novel portfolio of first in class and best in class novel therapeutics in discovery stage to Phase 3 clinical stage.

Theialife is currently building a global leadership team in Boston, as a prerequisite to list on NASDAQ.

Our lead molecule ND 10 for early onset paediatric myopia control will be applying for EU Marketing Authorization in Q1-2025 and US FDA pre submission meeting NDA meeting also in Q1-2025.

As you are probably familiar with the drug discovery journey you will appreciate that is the culmination of 18 years of effort, perseverance, and devotion to a single-minded goal of creating a global biopharmaceutical company. The myopia drug opportunity is itself over USD 20 billion and there is no other therapeutic in clinical development except Atropine which has had efficacy endpoint issues. We are adding new large manufacturing capability including a 2-million-liter microbial fermentation bio foundry and significant dosage form capacity.

By 2030 we intend to be amongst the World’s top 5 Ophthalmology innovation led global companies.

To support, build and develop our pipeline we are looking to add Scientists, Doctors and Engineers and Technical People to our team of likeminded dedicated science warriors who have devoted their lives to pursue excellence and contribute to finding medical solutions for significant global unmet medical needs.

POSITION SUMMARY:

Bioplus 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 interactions

Portfolio-Specific 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 constraints.

QUALIFICATIONS

• 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).

WHAT WE OFFER

• Opportunities for professional development and career growth.
• A collaborative and innovative work environment.

WHY JOIN BIOPLUS?

Bioplus offers a unique opportunity to make a significant impact on global healthcare by shaping the commercial success of novel, life-changing therapies. As part of our team, you’ll collaborate with passionate professionals committed to improving patient outcomes worldwide.

EQUAL EMPLOYMENT OPPORTUNITY (EEO) POLICY:

Career opportunities at Bioplus are provided without discrimination on the basis of race, sex/gender, religion/caste/creed, social or ethnic origin, colour, age, differently abled (including physical medical conditions), sexual orientation, domestic partnership status, gender identity or expression, marital status, ancestry, genetic information or any other reason prohibited by laws in India.

REFERENCE: https://bioplus.in / https://theialife.com

For further information, contact:

Hemant Patel, DGM – Human Resources

Email: recruitment@bioplus.in