Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary / Objective

The GRS-CMC Director Devices and Combination Products will manage a team of two or more, primarily with responsibility for device and combination product strategy and related business processes. The Director will oversee individuals acting as subject matter experts providing support to project teams and GRS-CMC project leads.

The Devices and Combination Products group will collaborate with stakeholders across functional areas to develop/enhance business processes with an overall goal of ensuring regulatory compliance and efficient processes. The group will also participate on due diligence/in-licensing projects.

The Director will represent GRS-CMC on cross-functional and governance committees and lead and/or actively participates in departmental and/or cross-functional initiatives aligned with business priorities. Serve as a credible, respected spokesperson in discussions with key stakeholders. Develop and communicate strategic direction based on global regulatory guidelines and experience. Seek opportunities for external regulatory engagement for themselves and/or members of their team.

Position Responsibilities

In addition to information in the position summary, the GRS-CMC Director Devices and Combination Products is responsible for the following:

* Coordinate and provide oversight/guidance to develop and maintain appropriate procedural documents, white papers and guidelines within GRS-CMC related to devices and combination products

* Provide oversight to subject matter experts (SMEs) focused on Regulatory-CMC device and combination product guidelines and regulations, including developing and coordinating relationships with Notified Bodies in Europe.

* Develop and communicate strategic direction based on global regulatory guidelines and experience.

* Work effectively with stakeholders to understand functional interdependencies, assess impact on effective processes, develop mutually agreed-upon optimized processes and drive key cross-functional initiatives and business imperatives

* Manage and actively support growth and development of direct reports.

* Build strong trust-based relationships with stakeholders within the broader Global Regulatory organization, as well as, Global Product Development and Supply (GPS).

Experience/Degree Requirements

* Minimum BA/BS Degree

* Minimum 10 years pharmaceutical or related experience, prefer multidiscipline

* Device and/or combination product related experience

* Knowledge of CMC regulatory requirements during development and post-approval phases, with emphasis on devices and combination products

* Ability to develop/maintain strong working relationships, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently

* Ability to identify, communicate and resolve routine/complex issues

* Ability to identify trends and changes in regulations affecting the regulatory landscape and recommend changes in internal business processes, where necessary

* Strong oral and written skills

* Prior management skills preferred

* Occasional travel required

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.