Director Clinical Affairs

for a leading company in topical formulations development and commercialization; located in Northern Calif.

Responsible for managing the development and review of protocols, informed consents, case report forms, clinical study reports and monitoring tools.

Develops and manages clinical study budgets.

Maintains internal contact with data management, regulatory, pre-clinical, QA, drug safety and biostatistics.

Provides direction to contract CRAs and maintains assurance of regulatory compliance of investigational sites with SOPs, FDA and ICH guidelines.

Provides leadership of market research activities in the development and implementation of product business plans to support pipeline products and business development activities.

Designs and analyzes qualitative and quanitative marketing research projects.

Works with bread teams to provide analyses of primary/secondary data and guidance in developing strategies and business plans.

Requires bachelor's degree (MS/MBA preferred) and 3-5 years experience in marketing/market research in the healthcare industry.

Oncology market research experience is highly preferred.

Must have strong understanding of primary and secondary research sources and databases.

Compensation: to $125K range + bonus + stock.