Associate Director

Syngene

15 - 20 years

40 - 45 Lacs

bengaluru

Posted:1 day ago| Platform:

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Skills Required

toxicology business development manager pharma workflow glp budgeting continuous improvement forecasting operations auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Scientific Leadership:

Drive adoption of new technologies and methodologies to improve study accuracy and efficiency. Example, adopting best practices, standardizing workflow, eliminating unrequired steps. Standardized templates will reduce manual errors and cut turnaround time.

Regulatory and Compliance:

Provide expert toxicological risk assessments for new compounds and formulations to support regulatory submission. Example, in silico modelling, read-across techniques, literature reviews, and derivation of PDE and OEL values.
Ensure timely submission of regulatory responses to meet 98% on-time compliance rate. Example, CAPAs, and deviation closures using TrackWise.
Reinforce GLP adherence and expand compliance oversight to evolving regulatory expectations. Example, targeted internal training, proactive gap assessment.

Client and Stakeholder Engagement:

Serve as the primary toxicology contact for pharmaceutical and biotech clients, guiding them from study design to final reporting. Example, business query meeting, project kick-off meeting, project update meetings, ad hoc meeting

Team and Operational Management:

Manage operational aspects including budgeting, staffing, and resource allocation. Example, resource forecasting that aligned staffing levels with study demand.
Drive continuous improvement in workflows, data integrity, and operational efficiency. Example, to make team audit readiness
Expand coaching and mentoring initiatives to build team capability and resilience. Example, Knowledge-sharing, fostering cross-functional learning, strengthening scientific expertise.

Business Development and Growth:

Standardize and validate innovative toxicology methods. Example, transcriptomic analysis
Stay current with emerging approaches such as in silico techniques and New Approach Methodologies (NAMs), AI-driven predictive modelling.
Contribute to scientific literature through publications on novel endpoints, white papers on regulatory trends, and participation in international conferences.
Cultivate a culture of innovation and excellence within the toxicology function. Example, recognizing scientific excellence through internal awards.

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