Head of Pre-Clinical Development (PSS07837)

About The Company

One of India’s largest pharmaceutical companies is expanding its innovative medicines portfolio across biologics and small-molecule programs. The organization is focused on translating scientific innovation into differentiated therapies that improve patient outcomes globally, supported by a strong R&D foundation and a growing international footprint.

Position Overview

The Head of Pre-clinical Development will lead the pre-clinical strategy and assets in development, driving global clinical development strategies that bring transformative therapies to patients. Reporting to senior R&D leadership, this role will work cross-functionally with discovery, regulatory, commercial, and business development teams to advance innovative biologic and small-molecule programs toward Phase I studies.

Key Responsibilities

• Lead preclinical activities to provide IND-enabling data for regulatory submissions.
• Design, execute, and interpret non-clinical studies including in vivo, in vitro, and in silico models, as well as toxicology evaluations.
• Write study protocols, draft and review final reports, and present data to senior leadership.
• Oversee internal and external research studies across multiple programs, ensuring data integrity and timely delivery.
• Identify and manage CROs, academic groups, and partners for preclinical and bioassay studies supporting mechanism-of-action and lead candidate selection.
• Guide scientific staff to align research with corporate, partnering, and intellectual property objectives.
• Assess risks, develop mitigation strategies, and support due diligence for in-licensing and regulatory submissions.
• Contribute to scientific communications, including posters, publications, patent applications, and investor relations materials.
• Collaborate with global clinical development, commercial, and medical affairs teams to ensure preclinical data supports value demonstration and progression to Phase I.
• Build external partnerships with organizations such as Gates and Wellcome to mobilize funding and expand collaborative development programs.
• Represent the preclinical perspective in business development and co-development discussions.
  
  
  

Required Experience & Qualifications

• Education: PhD in biological or pharmaceutical sciences.
• Experience: 10+ years in pre-clinical development of biologics and/or small molecules within leading pharma or biotech organizations.
• Leadership: Proven success leading preclinical discovery groups and managing cross-functional scientific teams.
• Technical Expertise: Experience in toxicology, CMC, mechanism cycle optimization, antibody design, and modeling approaches for human dose selection; strong understanding of multi-regional regulatory requirements.
• Soft Skills: Strategic thinker with a global mindset, integrating scientific innovation, operational pragmatism, and commercial insight; willingness to travel internationally and engage with India-based R&D teams in Mumbai and Delhi.
  
  
  

Why Consider this Opportunity?

• Shape the future of innovation within one of India’s fastest-growing global pharmaceutical companies.
• Lead the development of breakthrough therapies across biologics and small molecules.
• Drive science from the bench to the bedside, influencing global patient access.
• Collaborate with world-class partners and funding agencies to expand R&D impact.
• Play a pivotal role in building a next-generation pipeline of innovative medicines.