Head of Devices CoE

Head of Devices CoE

JOB FUNCTION: Research and Development

DIVISION: PRD

BUSINESS UNIT/LINE: BTx PhRD

DEPARTMENT NAME/DEPT ID: Devices Centre of Excellence Cambridge

LOCATION: Cambridge UK

REPORTS TO POSITION TITLE: Vice President Head of PhRD

POSITION SUMMARY

This position is in the Biotherapeutics Pharmaceutical Sciences Research and Development Devices Centre of Excellence located in Cambridge UK. The successful candidate will lead the Devices Centre of Excellence (DCoE). The Devices CoE is responsible for:

• Leading developing and delivering Pfizers device needs in support of the existing R&D portfolio for both BTxPS and PSSM

• Supporting PGS in life cycle management and maintenance of Pfizers devicebased franchises

• Identifying and evaluating devicebased technologies to support the future portfolio and patient needs

The successful candidate will provide leadership and scientific expertise for the global development of delivery devices and devicebased biotherapeutic drug combination successful candidate will be responsible for working in collaboration with the Senior Directors of DPDD and Pharmaceutical R&D (PhRD) Leadership Team to provide the strategic direction and management of the drug product related aspects of the biotherapeutics product portfolio which require a delivery device.

POSITION RESPONSIBILITIES

Head of Devices CoE

• Provide strategic scientific and technical guidance required to successfully develop Pfizers products which require a delivery device

• Lead the DCoE Management Team to build and develop capabilities to meet the project portfolio requirements and enhance its scientific reputation and visibility both internally and externally.

• Lead and support the team of Device Development Leads accountable for managing the development and industrialization of drug delivery devices and combination products according to established procedures and processes from concept phase through to regulatory submission and prelaunch activities.

• Responsible for building and maintaining relationships with other development manufacturing and commercial functions in a culture of continuous improvement

• Works in partnership with the Senior Directors of DPDD to provide a consistent and highfunctioning organization across sites focused on delivering the right product for the patient and HCP.

• Works closely with and is a member of the PhRD leadership team to provide a strategic vision and deliver the portfolio in an open efficient and effective work environment.

• Attracts retains and develops worldclass development talent by maintaining high internal and external visibility and creating a culture of continuous career development and performance feedback

• Develop the structure and form of the group to best achieve technical regulatory and business needs.

• Develop the culture of the organisation to embrace all Pfizer Values providing opportunities for colleagues to participate in broader initiatives across Pfizer UK and within PhRD / BTxPS

• Respond to the changing project workload managing capacity using FTEs contract workers and external partnerships as required.

• Prioritise and plan incoming work in order to balance the work relative to the team capacity. Predict future work requirements both in terms of capacity capability and device technologies.

• Support all DCoE disciplines to achieve success. Disciplines include:

  • Project Management: leading the device constituent of PrePOC CoDev and select LCM programs working with key stakeholders across Pfizer and strategic partners

  • Compliance: ensuring compliance with QA and regulatory needs for design control and risk management

  • Design: including design for reliability industrial design earlystage usability and product due diligence / market intelligence

  • Workshop facilities: Manufacture of prototypes rigs fixtures etc.

  • Human Factors: including IFU creation combination product and medical device validation

  • Development Sciences; including design verification specification setting control strategy development process validation and shipping studies

  • Laboratory facilities; including biohazard handling for clinical complaints product stability; low bioburden filled primary container manufacture and mechanical analytical capabilities

  • Commercial: support for contract negotiations and management of key external vendors

  • Industrialisation: support for creation of phase 3 manufacturing facilities at PGS and external locations including specifying and ordering manufacturing equipment and validation of equipment. Provide SME input to PGS in commercial scale up activities and site sourcing

• Ensuring compliance to the Pfizer Global Design Control procedures required for product development to ISO13485 and to meet global regulatory requirements.

• Coach and support the group leaders ensuring they are equipped for the task in hand and that they can lead their groups successfully.

• Identify training needs and source external training relevant to the needs if no internal course available. Ensure compliance to training metrics.

• Manage compliance to the department budget as applicable travel capital resourcing etc.

• Establish and manage the longterm strategy for the provision of device solutions for PRD (BTxPS and PSSM) and life cycle management including collaboration with GT&E MDCP (PGS).

• Establish and manage relations with partner groups in order to fulfil the needs of the portfolio and future strategy in particular Device GCMC and MDCP QA.

• Ensure all regulatory submissions are reviewed and approved in accordance with Pfizer Policy and act as lead signatory on behalf of the Devices CoE

• Support PGS and the BUs in the creation of business cases for combination product developments in support of the portfolio. Consider strategic opportunities in the device space providing a business rationale.

• Developing proposals recommendations and options for device development to meet business requirements for both new and existing assets.

• Supporting design reviews both internally and with external vendors to establish a consistent approach across the portfolio.

• Supporting continuous improvement activities across DCoE for both product and processes with the aim of ensuring consistency compliance and greater efficiency.

• Leading the process to forecast resource requirements for DCoE.

• Conduct due diligence operations as required on the device constituent of business development opportunities and new programmes.

• Work with People Experience (Px) contact to ensure compliance to Px policies and procedures.

• Ensure compliance to project and other goals set within BTxPS.

• Works closely with and is a member of the PhRD leadership team to provide a strategic vision in an open efficient and effective work environment.

ORGANIZATIONAL RELATIONSHIPS

• Pharmaceutical Research & Development Leadership Teams (PhRD LT ELT & BTxPS LT)

• Direct Reports on DCoE Management Team (MT)

• Device Development Leads

• Design Engineering and Sciences Team Lead

• Compliance Team Lead

• Human Factors Team Lead

• Industrialisation and Business Management Team Lead

• Site Administrator

• Device CoE Colleagues

• Pfizer Colleagues based in Cambridge

• PharmSci Category Leads

• BTxPS PSSM & CoDevelopment Team Leads

• PSSM HBU Device & Packaging

• MDCP Quality Assurance

• GCMC (Regulatory)

• Pfizer Global Supply Central and site functions

• External designers vendors and suppliers

RESOURCES MANAGED

• Devices CoE Management Team

• Device Development Leads

• Devices CoE Budget

EDUCATION SKILLS AND EXPERIENCE

The Director should:

• Minimally have a bachelors degree in the Chemical Engineering or Life Sciences with an advanced graduate degree strongly preferred.

• Have extensive development experience with a preference for direct experience in the development of devices and combination drug products.

• Direct experience in the management of scientific / laboratory staff and have a demonstrated background in development of delivery devices and combination products in a matrix environment.

• Experience with principles of device design control as well as knowledge of ISO13485 ISO14971 ISO62366 and global regulatory requirements such as EU Medical Device Regulations

• Knowledge of the requirements of the device sections of BLAs MAAs INDs IMPDs and CTDs

• Demonstrated strong track record of building successful teams in a technical environment with a focus on innovation and meeting customers needs.

• Able to prioritise multiple responsibilities and to work on multiple tasks simultaneously

• Able to demonstrate practical analytical and pragmatic approach to work

• Able to communicate clearly and concisely with internal and external team members in an appropriate oral and/or written format

• Able to articulate ideas and concepts clearly to all levels and technical abilities

• Able to learn and understand new concepts quickly

• Able to learn and apply established procedures in a reliable and consistent manner

• Capable of seeing the wider implications of all decisions

• Excellent standard of written and spoken English and numeracy

• Comfortable working to agreed deadlines

• Takes pride in the quality of their work

TECHNICAL SKILLS REQUIREMENTS

Demonstrated technical knowledge towards the development of delivery devices and combination products.

Strong track record of initiating productive collaborations with other groups both internal and external to the group and company.

Demonstrated ability to develop scientific staff and effectively use of performance management tools.

Excellent written and oral communication skills

Extensive knowledge of and experience across key stages of drug discovery development and commercialization.

Experience with Quality / Compliance and regulatory requirements in the areas of delivery devices and combination products

PHYSICAL POSITION REQUIREMENTS

Sitting and driving license.

Position will require some level of domestic and international travel. Frequency and duration will be variable but should not exceed 2030 of the time. No physical demands outside the requirements of a normal office are expected.

COMPETENCIES

Decisive Is an agile learner who synthesizes complex information to determine the best course of action.

Focused Holds self and others accountable for consistently meeting needs of customers and stakeholders.

Connected Builds effective professional relationships with internal and external stakeholders.

Courageous Shows consistency between words and actions gaining peoples trust and respect.

Resilient Adapts or shifts priorities in response to the needs of clients constituents or the organization

This description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required. Additional position specific requirements/responsibilities are contained in approved training curricula.

Work Location Assignment:On Premise

Purpose

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