Director of Drug Development

Location
Morristown, New Jersey
Salary
Competitive pay
Posted
06 Sep 2019
Closes
06 Oct 2019
Ref
mcvl
Hours
Full Time
Contract Type
Permanent
Experience Level
Director/Executive

Director of Drug Development

Morristown, New Jersey

Overview: My client is a prescription and OTC drug pharmaceutical company that is looking for a Director of Drug Development to join their team in New Jersey. This person would manage the drug development team, report to the president, and is responsible for all oversight of all R&D activities.

The Company: My client is a leading name in Japanese prescription and OTC drugs. Established in 2001, they are a pharmaceutical company that focuses in the research and development of prescription pharmaceuticals. Their R&D strategy is centered around developing drugs with a high standard of originality. Their focus areas include “infectious diseases,” “orthopedic disorders,” “CNS,” and “metabolic diseases” in Phase I and Phase II. While they promote in-house drug development, they also promote alliances with Japanese and overseas companies to continually improve pipelines.

The Director of Drug Development will be responsible for:

-Oversee all functions of studies in clinical development (Phase I and Phase II)

-Leading the scientific, regulatory affairs, and clinical development operations for all US based projects

-Work alongside executive management in the US and Japan H.Q.to consult about clinical study plan and then promoting the company’s drug development plan to outside partners (KOL’s, CRO’s, etc.)

-Prepares regulatory documents such as Dossiers, BLAs, INDs, Safety and Handling reports

-Shapes and oversees the design and implementation of clinical research programs including:

  • Submission of INDs
  • Development of Clinical Development Plans (CDP)
  • Investigator Brochures (IB)
  • Annual safety reports (DSUR)

-Consult with preclinical laboratories (toxicology, ADME, pharmacology, and CMC) to provide scientific, developmental, and clinical expertise.

-Develops a strong team that interacts efficiently and professionally with investigators, site research personnel, scientists, CROs and other internal and external parties.

-Manages all external and internal vendor relationships.

-Plans and chairs scientific advisory committee meetings with industry expert

-Ensures all components are in place for QA and QC.

Requirements for this role:

-10-15 years of relevant industry experience

-PhD in related field

-Solid experience with Phase I and Phase II drug development

-Clinical experience in CNS (or any psychiatry fields)

If you would like to apply please do so here, or send your resume to Mvalletta@gmail.com

I can be reached at 919-838-7478 for more information.

https://www.linkedin.com/in/mackenzie-valletta-a5741818a/

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