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 OverviewThe
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.
