Global Head Research And Development

We are partnering with an international pharmaceutical company who has global presence, focused on commercializing novel and generic pharmaceuticals to identify Global Head - R&D for Hyderabad. The position will report to COO, Based outside of India.

Location : Hyderabad

Industry : Pharmaceutical industry

Experience : 20+ years of experience in the area of oncology product development and generic drug development

Qualification : Ph D must

CTC – not a constrain for the right candidate

Age - max 51 yrs

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Summary of Position :

The Global Head R&D will lead and grow a 60+ team of formulation scientists, analytical scientists and other technical professionals with responsibility for developing products (mainly oral solid dosage forms). This includes leading the identification of a strong pipeline of projects to support consistent flow of ANDA and NDA filings. These scientists are in Hyderabad India.

This position will have responsibility for creating a culture and atmosphere aligned with the company values, building key technical and leadership capabilities within the teams and maintaining a productive, diverse, and engaged workforce, comprised of the best talent.

Responsibilities :

• Set strategic direction, determine goals / objectives / priorities for multi-disciplinary team of scientists with responsibility for product formulation, method development, method validation, stability testing, R&D tech transfer, Authorities deficiency response and technical filings.
• Ensure constant flow of ANDA and NDA filings for new project launches, through oversight of project timelines and budgets.
• Prior experience of managing successful approval process for US &European Markets
• Overall team leadership includes setting individual / team goal, ensuring employee development, providing on-going coaching and feedback, recognizing employees for their contributions and creating an inclusive and safe work environment.
• Ensure (internal and external) audits and review procedures, processes, data and laboratory preparedness for inspections.
• Ensure all work is completed within cGMP, SOP, FDA, ICH guidelines, including ensuring staff is fully trained in all requirements.
• Provide technical direction and guidance to the team in response to deficiency letters and ensure timely deliverables.
• Prepare and manage budgets for staffing resources, laboratory supplies and capital expenditures
• Participate as a member (key driver) of cross-functional teams including partnership with Regulatory, R&D, Manufacturing, Procurement, etc., to ensure achievements of company goals.
• Identify new technology for implementation to ensure R&D remains current with the industry.
Qualifications :
• Phd must
• 20+ years of experience in the area of generic drug development & oncology product development.
• Thorough knowledge of oral dosage forms is required, including understanding of production, clinical studies and regulatory requirements.
• 5+ years supervisory experience of multi-disciplinary R&D organization, including leadership of people managers.
• Strong people leadership skills include setting individual and team goals, providing feedback, recognizing strong performance, providing coaching and facilitating career development.
• Strong interpersonal skills to influence and guide internal and external stakeholders effectively.
• Ability to partner cross-functionally and work on cross-functional teams (QA / QC, Regulatory, Manufacturing, Procurement, etc.).
• Proven ability to manage progress and delivery of consistent flow of ANDA and NDA filings.

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Skills Required

Method Validation, stability testing , Sop, Cgmp, Method Development, Product Formulation