SENIOR PRODUCT/MARKETING MANAGER
The Senior Product/Marketing Manager will play a key role in the development and execution of marketing strategies and tactics to support the launch and subsequent marketing of a new product for the treatment of opioid dependence. The position will be responsible for working closely with the commercial team, internal stakeholders, vendors, and agencies to help assure launch readiness and strong marketing support to facilitate product uptake at launch. The position, in conjunction with commercial colleagues, will identify appropriate strategies and tactics to meet business objectives, and subsequently develop, and execute programs with a high degree of innovativeness, quality and timeliness - and within budget. The position will also be involved in marketing research and competitive intelligence activities, and other related activities as they arise. The position will report to the Vice President of Marketing.
1) Support the development of brand plans and budgets. Monitor progress of plans and make adjustments as necessary.
2) Plan and execute market activities, working independently and in conjunction with Medical Affairs, including advisory boards, speaker programs, medical education, peer-to-peer programs, and development of promotional and educational materials for healthcare practitioners and patients.
3) Manage the development of print and digital marketing materials and advertising.
4) Interact with and support the company/product with key opinion leaders and advocacy groups.
5) Manage medical conferences and meetings, including the exhibit booth and other peripheral activities.
6) Manage internet, e-marketing activities, and social media programs.
7) Monitor and assure that all marketing programs and materials are complaint with corporate compliance policies.
1) Bachelor in Business, Arts or Science; MBA preferred
2) Minimum 8 years of related marketing experience in the biotech/pharmaceutical industry.
3) Industry sales experience beneficial and desired, but not required.
4) Pain or addiction medicine experience/knowledge is beneficial, but not required.
5) Product launch experience
6) Recent experience managing a marketed brand in a competitive environment.
7) Extensive experience in working with external vendors - particularly advertising, contract sales, and medical education agencies.
8) Demonstrated ability to work in a team environment.
9) Strong analytical skills and solid general business skills.
10) Demonstrated ability to manage multiple activities and prioritize effectively.
11) Hard working and willing to take on a wide range of responsibilities
12) Accustomed to and comfortable with working in an environment with limited resources.
13) Excellent written and oral communication skills.
Senior Director, Technical Operations
Implementation of Process Analytical Technologies necessary for robust manufacturing and COG minimization, trouble shooting and problem solving to ensure reliability at CMO manufacturing sites. Provides leadership on production campaigns, and coordinates COGs reduction strategies. The person in this role will coordinate product manufacturing, commercial packaging, and product release in assistance with Quality Control and Quality Assurance. He/she will be responsible for inventory and supply chain management. The person will interact very closely with key stakeholders in R&D, technical operations product management, and supply chain function. The person will ensure communication flow, resolve issues and understand inputs affecting the outsourcing activities.
The individual in this position will lead the contract development operations team to support development and support corporate outsourcing strategy.
1) Support CMO selection decisions for project-specific commercial manufacturing operations
2)Foster a culture of high performance across all CMO stakeholders. Build and cultivate a strong network among R&D, technical functions, QC, QA, and management of project teams
3) Demonstrate business and operational leadership capabilities.
4) Technical Experience in solidoral dosage forms including oral thin films, transdermal system, product manufacturing, process engineering, and validation processes.
5) Ability to travel approximately 20%. (or living near CMO site.)
Education and Experience:
1) Ph.D. degree in Engineering and/or MBA in General Management
2) >15 years of experience in the pharmaceutical industry, including Technical Operations and Manufacturing. Experience in managing a CMO/CRO network is a plus
VP Pharmaceutical Development Job Description
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.
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
Submitting Resumes by Mail:
BioDelivery Sciences International
Attn: Office Manager
801 Corporate Center Drive, Suite 210
Raleigh, NC 27607
Submitting Resumes Online: