Senior Director of Research and Development

Company Information:
Our client is a biopharmaceutical / medical device company with promising products in development. This is an excellent opportunity for an industry-experienced physician, Board Certified in Infectious Disease (or related area) in a rapidly growing company where you will be rubbing elbows open-minded individuals who are always considering new ideas.

The Senior Director oversees and manages the global research and development program for products, from early development to regulatory approval and beyond, in order to achieve a high quality product for the marketplace and business success for company.

Job Responsibilities:
Oversee the clinical development and FDA drug trials, and development of existing and future products to ensure high scientific, ethical and regulatory standards, and expeditious registration submissions.
Establish and maintain effective communication and collaboration with functional area peers and staff, including basic research, manufacturing, regulatory, quality assurance, project management, and marketing in order to meet program objectives and support achievement of department and corporate goals.
Effectively communicate and coordinate with Medical Affairs department to ensure, timely, professional, and accurate dissemination of relevant scientific and clinical data to the medical and healthcare community.
Serve as the clinical lead in product development and in compiling and managing the resulting FDA filing/submission.
Provide medical support for interactions with regulator-agency reviewing divisions.
Ability to conduct independent thinking and scientific interpretation of data as well as ability to provide excellent written and oral communication in interpretation of data to other functional groups and external partners.
Have the ability to successfully interact with senior managers within company, the FDA and externally.
Manage internal resources, external partners, consultants, vendors and budget to ensure the timely and cost-effective implementation.
Oversee preparation and approve budgets and proposed pre/post decision criteria for the product development ensuring the needs and requirements of all regions are met.
Supervise direct and indirect staff. REQUIREMENTS
Job Qualifications:
MD degree. Board Certification in Infectious Diseases or related area preferred.
Knowledge and understanding of the pharmaceutical business, worldwide product development, and regulatory processes.
5+ years of experience planning and executing clinical trials of investigational new drugs (antibiotic experience preferred), with direct involvement in preparing, submitting and defending one or more applications for marketing authorization (NDA, BLA or equivalent).
Experience in a wound care, biotech or pharmaceutical industry preferred
Knowledge of pharmaceutical business, worldwide product development and regulatory process.
Expertise in clinical trial design and development to conduct and interpret scientific data.
Demonstrated ability to plan and lead the growth of an evolving organization is desirable.
Demonstrated leadership abilities, including setting a vision for others and driving to achievement of objectives in accordance with allocated resources and timelines.
Respected by scientific/medical peers in a way that allows for credible presentation and defense of clinical experienced and resulting data regardless of the forum.
Clear communication skills, written and verbal are extremely important
Able to perform multiple tasks
Excellent leadership and managerial skills
Excellent project management skills

Salary: Dependent on Experience

Location: Northern California (North of San Francisco)

For a confidential consideration please forward your resume in a Word document to [Click here for email].

Visit www.mrwg.com to view additional job opportunities available through our company.