Head of Device & Product Development - United States
- Our company is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives.
- Our purpose as a company is to discover and develop therapies that will change the course of human health.
- We value our passion for patients, quest for innovation, spirit of independence and love of challenge.
- With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
- The incumbent is expected to build and lead a group of experts in medical devices to support drug/device combination product development for our company’s portfolio of products. The group’s scope includes the development and commercialization of drug delivery devices such as pre-filled syringes, auto injectors or infusion pumps in collaboration with third party device development firms, and device manufacturers.
- S/he will collaborate with other departments within Global Pharmaceutical Development and Operations, Regulatory Affairs and Clinical Development to complete the studies and regulatory filings and support the commercialization of drug/device combination products.
- Build a center of excellence for the development and commercialization of drug delivery devices in support of combination products.
- CoE should provide subject matter expertise on concepts, principles & processes for device engineering and combination product development.
- Develop systems and business processes to ensure effective combination product outcomes, and regulatory compliance.
- All related activities should be conducted in a manner compliant with applicable regulations and industry standards.
- Own design control, design modification and change control activities across the life-cycle. Own the generation /management of the Device History File, including the ongoing review of said file. Manage technical reports, device testing protocols, validation reports, IND and BLA/MAA sections related to device design and manufacturing.
- Identify and evaluate potential value-adding opportunities for use of medical devices to enhance our company’s and alliance partners’ products and associated technology platforms, including cell processing, companion diagnostics or patient health monitors.
- Participate in development of product life-cycle management (LCM) strategies and in LCM teams.
- Identify and manage relationships with alliance partners and vendors.
- In collaboration with Franchise LCM leads and Global Development Teams define the requirements and specifications for drug/device combination products.
- Establish department interactions with external and internal stakeholders in Quality, Supply Chain, CMC teams, Technical Commercialization teams and the Global Project Teams.
- Working with Technical Commercialization teams, develop the concept and plans and operationalize the development and commercialization of a drug/device combination product.
- In collaboration with drug product development, Quality and Regulatory CMC subject matter experts deliver the required documentation in support of regulatory filings.
- Represent our company at relevant industry meetings and forums to ensure that our company approaches stay current with industry trends and best practices with respect to emerging device delivery technologies.
- Recruit and develop engineers and managers for the department.
- 15+ yrs experience in the pharmaceutical industry with >5 yrs. in a leadership position in the pharmaceutical industry
- 5+ years of experience in drug delivery device development and commercialization.
- 10+ years of experience in design review and approval process for drug device combination products.
- Experience in developing the strategy for global commercialization of drug delivery devices.
- Experience in devices for companion diagnostics or patient assessment is a plus.
- Experience selecting, qualifying and integrating container closure systems for sensitive biologics.
- In-depth knowledge of all phases of drug development and commercialization and project management principles applicable to the biopharmaceutical environment
- Experience with planning and execution of launch strategy and bio/pharm product lifecycle management
- Demonstrated leadership skills
- Excellent negotiation skills
- Proven ability to effectively develop, communicate and gain support for execution plans with a wide range of stakeholders
- Results oriented individual to execute strategy and meet objectives
- Experience managing change in a dynamic, complex environment
- Background in cGxPs and ICH requirements
- Our company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
- Our company complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for our company in the U.S.