Head of Preclinical Development

About the Role:

Mankind Pharma, in India’s 4th largest pharma company, head quartered in Delhi, is expanding its innovative medicines portfolio across biologics and small-molecule programs.

In this senior leadership role, you will define and drive global clinical development strategies that bring transformative therapies to patients. Reporting to senior R&D leadership, you will work cross-functionally with discovery chemistry and biology regulatory, commercial, and business development teams to translate scientific innovation at Mankind and its affiliates into differentiated medicines. You goal will be pre-clinical development on key internal and external assets focused across multiple geographies and multiple sites and liaise with the CRO network to enable the preclinical assays include toxicology and CMC.

This position can be based at Delhi or Mumbai Office.

The incumbent must have led preclinical development programs ideally in both small molecules as well as larger molecules in innovative discovery space in a large organization.

The incumbent will also play a key role in shaping Mankind’s external innovation agenda, building global collaborations and cost-effective development partnerships that expand the reach and impact of our innovative medicines R&D pipeline and push the molecules towards Phase I studies.

Key Responsibilities

• Lead preclinical activities to provide enabling data for regulatory submissions.
• Contribute execution and interpretation of non-clinical studies, including in vivo, in vitro, and in silico studies, toxicology studies for the evaluation and characterization of new small or large molecule therapeutics.
• Write study protocols, draft and review final reports for internal and external use; organize data presentations and report to senior leadership. Coordinate day-to-day execution/oversight of internal/external Research studies for multiple programs, ensuring performance, timelines, and integrity of data.
• Identify and vet CROs, academic groups, or organizations to conduct preclinical and bioassay studies related to mechanism of action understanding, preclinical compound testing and lead candidate selection and development.
• Coordinate day-to-day execution/oversight of internal/external Research studies for multiple programs, ensuring performance, timelines, and integrity of data.
• Manage and work closely with the scientific staff to ensure alignment with corporate/partnering and IP needs.
• Contribute to the development of research programs based on an understanding of the pathophysiology of disease and mechanism of action.
• Identify risks, develop risk mitigation plans, and escalate risk mitigation strategies.
• Contribute to in-licensing program due diligence and regulatory submissions.
• Contribute to the generation of company public disclosures including scientific posters and publications, patent applications, and IR documents.
• Work with the global clinical development teams for both biologic and small-molecule innovation lead assets, ensuring alignment with scientific, regulatory, and commercial objectives across multiple geographies.
• Helping build a portfolio of innovative medicines programs at Mankind. In a matrix structure of Mankind R&D.
• Build a network of external partnerships with Gates, Wellcome and other funding agencies to help build collaborative development programs as well as mobilise the external funding opportunities.
• Collaborate with commercial, medical affairs, and market access to ensure preclinical data supports value demonstration and progression to phase I.
• Represent the preclinical perspective in business development evaluations and external partnership discussions, supporting in-licensing and co-development opportunities.

Experience & Qualifications

• PhD in biological or pharmaceutical sciences.
• 10+ years of experience in pre-clinical development (biologics and/or small molecules) within leading pharma or biotech.