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Head of Pre-Clinical Development

10 - 15 years

30 - 35 Lacs

mumbai new delhi

Posted:1 day ago| Platform: Naukri logo

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Skills Required

toxicology medical affairs due diligence investor relations pharma intellectual property clinical development research licensing operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

" 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.
#LI-NV1
",

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