Combination Product Development Director

Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

The CPDD, ADDS Commercial Development is responsible for leading commercial and business development elements of combination product development activities for the ADDS platform of devices and components, in collaboration with BD’s customers, the BD Project Management Organization, and BD cross-functional teams. These engagements with pharmaceutical companies are multi-year developments and incorporate multiple projects that involve all stages of drug and combination product development. This requires building long-term relationships, structuring and closing feasibility, development, and service agreements, and being a key commercial client liaison with the pharmaceutical company through the whole development cycle to eventual commercial launch of the combination product.

Responsibilities

Lead the business development and commercial development activities that arise during combination product development programs in collaboration with all appropriate levels of cross-functional BD teams and external customer teams to ensure success of the combination product program, as defined by the customer

Collaborate with Commercial Development, Sales, and other cross-functional internal and external teams to assess customer needs, timelines, resources, and material required to effectively communicate what development activities are required to successfully develop a combination product. Additionally, work with cross-functional teams, both internal and external, to ensure that all services offered by BD are offered to the pharmaceutical partner during the combination product development program.

Work across the matrix of BD to gain the cross functional support, engage subject matter experts and knowledge to effectively manage and support the combination product development project over time

Balance customer needs and requirements with BD’s strategy and goals by working closely with cross-functional teams to ensure the pharmaceutical client is receiving the resources that they need, while ensuring that BD’s stakeholders are engaged.

Understanding of various drug delivery primary container and device systems such as cartridges, prefilled syringes, safety devices, pens, autoinjectors, wearable injectors.

Guide and teach customers during the combination product development program.

Building strong industry knowledge of internal BDM-PS PFS and ADDS products along with all competitor products and capabilities.

Working knowledge of design history files and essential performance requirements for various drug/device combination products

Attend industry and medical conferences/trade shows that showcase competitors, universities, etc. and provide opportunities to engage with customers.

Working with the cross functional teams including marketing, R&D, medical and regulatory, ensure close understanding of the technical benefits and attributes of the products and communicate these with the pharmaceutical client. Communicate in the language of the buyer focusing on pharma benefits

Establish and leverage key contacts with global pharmaceutical/biotech key decision makers and consultants.

Manages the long-term relationship with customers by demonstrating diplomacy skills and a high level of trust within both organizations.

Education, Skills, and Experience Required: 

Bachelor’s degree in life sciences, scientific discipline, engineering. MBA preferred 

Experience in the drug/device combination product regulatory framework (FDA, MDR, etc)

A minimum of 7 years of drug/device combination product development experience – experience in sales/business development, research and development, program management or analytical services highly valued

Knowledge of the global injectable pharmaceutical market, drug delivery and medical device industry

Expertise and experience in the development and commercialization of drug/device combination products

Experience with FDA 820.30 design controls, regulations, guidance documents, and standards governing combination product development (ISO, FDA, MDR, ASTM, etc)

Working knowledge of ISO 11040 Part 8, 11608 Part 1 & 5

Experience and expertise in reviewing and revising legal documents

Experience and expertise in setting prices with underlying knowledge of a business P&L, gross profit margins, COGS, tiered volume prices, etc.

Experience and expertise working with external suppliers to develop quotations, set work specifications and/or expected outputs from a supplier, and enabling external suppliers to provide excellent service to our pharmaceutical partners.

Excellent presentation and writing skills and ability to present material and complex matters in a succinct and organized manner. 

International business and travel experience due to global scope of the role; willingness to travel extensively within and outside of the US, when required.

Additional Skills and Competencies Required: 

Technical understanding of pharmaceutical development and device development to enable connection with subject matter experts at BD to include the relevant experts and/or information at early stage of customer engagement

Project management, problem solving and leadership across a cross functional organization

Ability to think critically in tactical and strategic dimensions simultaneously.

Strong negotiation skills and experience.

Agility to prioritize tasks in real time and exercise judgment in high-stakes environment.

Strong ability to establish credibility, trust, and support with both internal and external constituents at all levels & functions of the organizations.

Demonstrated capability to effectively work across various functions to ensure deliverables are met against required timelines; project management experience required.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health.