Senior Director

2 weeks ago

Hyderabad, Telangana, India Ferring Pharmaceuticals Full time

Job Title: Associate Director – Bio-Clinical Studies

Job Summary:

Ferring Pharmaceuticals is seeking a highly experienced Associate Director to lead clinical and non-clinical projects and provide scientific support on biopharmaceutical development for LBOE & Global projects.

Key Responsibilities:

  • Develop and implement clinical and non-clinical study plans to achieve proof of concept and registration of products in India & global markets.
  • Manage study activities at CROs and Global Dept.'s to ensure compliance with Ferring/GxP/Regulatory requirements.
  • Provide scientific support to the development team on new product ideation, biopharmaceutical strategy, and evaluations.
  • Train project staff at Ferring and vendors (CROs) on GxP compliance.
  • Coordinate clinical and non-clinical study supplies, including Investigational Medicinal Product (IMP), to ensure timely delivery.
  • Manage medical writing, including protocol, ICD, CRF, and other study documents, to ensure high-quality output.
  • Ensure QA compliance for local clinical and non-clinical studies.
  • Review and submit dossier/notifications to IEC & Regulatory Authorities for clinical studies.
  • Supervise safety reporting to Ferring GVP center and Regulatory Authority.
  • Review scientific data, including PK/PD and statistical data/results, to ensure high-quality output.
  • Evaluate clinical and non-clinical study vendors and facilitate QA audit and selection.

Requirements:

  • Trained in Good Clinical Practices (GCP).
  • More than 10 years of experience in Clinical Trials and BA/BE studies management as a Clinical Trial Project Manager.
  • Experience in clinical trial supply management (IMP, biological samples, etc.).
  • Thorough knowledge of regulatory and ethical requirements, quality standards, PV, etc.
  • Skills in biopharmaceuticals related to NDDS development.
  • Knowledge and experience of non-clinical studies for pharmacokinetics and toxicity studies.
  • Experience in medical writing, biostatistics, data management, CTMS, vendor management, etc.
  • Experience of trial/study monitoring and handling GxP audit and regulatory inspections, etc.

Location: Ferring India FHPDC R&D

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