Positions available:
General Counsel Job Description
The General Counsel is responsible for:
1) the general administrative legal matters for the company.
2) all matters relating to BDSI's intellectual property.
3) the creation and maintenance of the company's contracts as well as managing and advising on all of the company's insurance policies.
4) creating and managing a budget for this area of responsibility.
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5) work concurrently with the various outside counsels supporting the intellectual property, contracts and SEC filings.
6) participation as appropriate from time to time in business development activities and in partnership meetings and discussions.
The candidate should possess:
1) A Bachelors Degree and Law Degree from an accredited Law School. Scientific degree in the Company's discipline and Patent and Trademark Registration and/or an advanced law degree considered a plus.
2) A minimum of 10 years of industry experience. Excellent written and verbal communication skills. Able to handle conflict and deal with multiple issues simultaneously.
VP Pharmaceutical Development Job Description
The Vice President is responsible for:
1) directing the formulation development, analytical method development, and process development activities for thin film products containing small molecules
2) production and quality control testing of clinical supplies.
3) ensuring compliance with requirements for CMC regulatory submissions.
4) reviewing study reports, manufacturing process documentation, investigator brochures, clinical study protocols, and clinical trial documentation for compliance with cGMPs, cGLPs and other appropriate regulations and guidelines for CMC related issues.
5) acting as liaison (with regulatory and quality personnel) with FDA, and other regulatory agencies for CMC issues.
6) reviewing proposed changes to regulated processes and /or products to identify regulatory implications.
7) working closely with quality systems organizations to identify and resolve CMC issues.
8) interacting with key scientific, clinical research, marketing and commercial personnel within and outside the Company to ensure timely and accurate regulatory compliance on CMC matters.
The ideal candidate will have:
1) 15+ years experience in industry as a CMC professional with successful NDA submissions and commercial product production.
2) experience in all phases of regulatory submissions and interactions regarding CMC issues, ideally including post-approval
experience with regulatory authorities on CMC issues.
3) senior management leadership experience for the CMC function in a pharmaceutical company,
4) excellent analytical, communication, presentation, and writing skills.
5) proven ability to work as a team member collaboratively with colleagues across all functions.
6) advanced degree in pharmaceutical sciences or chemistry
Director Formulation Development Job Description
The Director is responsible for:
1) developing pre-formulations and formulations for pipeline products including thin films with small molecules
2) managing vendor activities required for pre-formulation and formulation of new drug products including supervising physical and chemical tests
3) working closely with analytical and process engineering personnel to develop robust processes for testing and production
4) development and approval of master batch records
5) establishing in process and finished product specifications
6) writing stability protocols and reports
7) ensuring compliance with requirements for CMC regulatory submissions
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8) preparing and reviewing CMC documentation for IND and NDA filing
The ideal candidate will have:
1) 10+ years experience in industry as a CMC professional with record of NDA approved products
2) experience with formulation of polymer based products
3) mid-level management experience in a pharmaceutical company,
4) excellent problem solving, communication, presentation, and writing skills.
5) proven ability to work as a team member collaboratively with colleagues across all functions.
6) advanced degree in pharmaceutical sciences or chemistry
Submitting Resumes by Mail:
BioDelivery Sciences International
Attn: Office Manager
801 Corporate Center Drive, Suite 210
Raleigh, NC 27607
Submitting Resumes Online: