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.