Vacancy for Research Director- Pre-Clinical Development in Aurigene

Aurigene is a specialized biotech company, focused on oncology and inflammatory diseases. Aurigene has deep target and therapeutic area expertise, gained from the experience of multiple programs reaching global clinical development from its efforts. Aurigene has pioneered a unique, collaborative business model to work with pharma and biotech partners, in a win-win partnership that combines Aurigene’s deep expertise in oncology and inflammation, with our collaboration partners’ needs for expertise, scalability and high-quality, quick and cost-effective prosecution of targets.

Post: Research Director- Pre-Clinical Development

Job Description, Key Skills and Competencies:
* Experience of having led multiple IND/ IMPD filings with the US FDA/ EMEA or other European agencies
* Provide input into the design & implement study protocols, conduct & review preclinical studies performed by internal and external laboratory partners to ensure high quality and cost effective studies that meet international scientific and regulatory standards.
* Design & implement study protocols, prepare dossiers including IND & CTAs, review regulatory concerns.
* Review Toxicology, pharmacology, ADME, Toxicokinetic data for multiple projects for identifying potential risks &suggest risk management plan. Give inputs for design, interpretation & overall safety assessment.
* Possess excellent communication and organizational skills, and adept at liaising with multiple internal/external teams (internal project teams, QA & external regulatory agencies).
* Develop & review pre-clinical development strategic plan. A strong knowledge of safety and risk assessment principles and concepts.
* Prepare response to queries on non-clinical sections from regulatory agencies including FDA & EMEA.
* Demonstrated management and leadership skills
* Can influence decision making with customers/collaborators.

Desired Profile
* PhD in toxicology, pharmacology, drug metabolism or a closely related field.
* 15+ years of experience in Pre-clinical drug development with good understanding of business and regulatory requirements.
* Strong capability and track record in pre-clinical development and has previously successfully led early development teams in progressing compounds to clinic.
* Proven ability to apply broad multi-disciplinary expertise to problems to arrive at innovative strategies and solutions to support preclinical development.

Additional Information:
Experience: 15+ Years
Location: Hyderabad
Functional Area: Pre-Clinical, CR
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 31^st March, 2014