Associate Director – Bio-Clinical Studies

Role: Associate Director – Bio-clinical studies

Reporting to: Senior Director - Pharmaceutical Development

Location: Hyderabad

Experience: At least 15 years of industrial experience in the following:

• Drug product development in early to late phase clinical development.

  
  

• Hands on experience in BA-BE studies in healthy volunteers.

  
  

• Hands on experience in PK-PD translation

  
  

• Exposure to non-clinical studies will be an added advantage.

  
  

Qualification: M. Pharma/ M.S or Ph.D. (Pharmacology/Medicine) or equivalent from a reputed University.

Purpose of the Role:

Leading Clinical and non-clinical projects and scientific support on Biopharmaceutical development for LBOE & Global projects

Job Description

• Synopsis development, planning, conducting, and management of early to late phase clinical development studies to achieve Clinical studies for proof of concept /registration of product in India & global markets.

  
  

• Planning, conducting and management of BA/BE studies in healthy volunteers to achieve Proof of concept /registration of products in India & global markets.

  
  

• Planning, conducting, and management of non-clinical studies (PK/PD, toxicity, etc.)  to achieve non-clinical studies for Proof of concept /regulatory requirements

  
  

• Managing study activities at CROs and Global Dept.'s to achieve Management & compliance as per requirements of Ferring/GxP/ Regulatory 

  
  

• Scientific support to development team on new product ideation, biopharmaceutical strategy & evaluations; supporting for innovations to achieve NDDS development.

  
  

• Training of project staff at Ferring and vendors (CROs) to achieve Training for GxP compliance.

  
  

• Project Management - Clinical development, BA/BE & Non-clinical [Project presentations to Ferring committees; Project risk assessment and scientific assessments with KOLs and mitigation; project cost and resource planning and management] to achieve Project milestones.

  
  

• Coordination for clinical & non-clinical study supplies Investigational medicinal product (IMP, NIMP, stationary, biological sample, etc.) to achieve IMP supply.

  
  

• Managing medical writing (protocol, ICD, CRF, etc.) from CROs/Ferring to achieve Study documents at optimum quality.

  
  

• QA compliance for local Clinical and non-clinical studies to achieve Quality compliance.

  
  

• Review of dossier/notifications for submission to IEC & Regulatory Authorities for clinical studies to achieve Regulatory compliance.

  
  

• Supervising for safety reporting to Ferring GVP center and Regulatory Authority to achieve Regulatory & GCP compliance.

  
  

• Review of scientific data (PK / PD and statistical data/ results) to achieve High Quality data.

  
  

• Evaluation of clinical and non-clinical study Vendors & facilitating QA audit and selection of vendors to achieve Qualified vendors

  
  

• Support Ferring Global initiative for 'Collaborative Innovation' / Global creativity awards and support for identifying & evaluation of global/local collaborative organization to Nurture innovation for building pipeline.

  
  

Required Competencies

• Trained in Good Clinical Practices (GCP) 

  
  

• >10 years of experience in Clinical Trials and BA/BE studies management in capacity as Clinical Trial Project Manager

  
  

• Experience in clinical trial supply management (IMP, biological samples, etc.)

  
  

• Thorough knowledge of regulatory & ethical requirements, Quality standards, PV, etc. 

  
  

• Skills in Biopharmaceuticals related to NDDS development.

  
  

• Knowledge & 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.