Are you energized by a highly visible senior CMC leadership role that will allow you to drive and shape scientific innovation across an early phase portfolio?  If so, Director, Early Medicine Development CMC Leader (Large Molecule) may be an exciting opportunity to explore.

The Role

The purpose of this role is to ensure the successful CMC delivery of the large molecule early phase portfolio through influencing the medicine development strategy; leading delivery of the CMC, supply chain and regulatory targets; leading the high performing matrix team; and shaping the medicine and patient experience.

Key Responsibilities

Leads CMC development of medicines and CMC matrix teams:

• Leads the definition and implementation of the early CMC development strategy and provides options for CMC delivery to align with the project objectives, with recommendations based on sound judgement on both short- and long-term implications (risks, costs, resources and time) for the early development of the medicine.

• Leads the cross-functional multi-disciplinary CMC matrix team to develop and execute the CMC project plans to accomplish the project aligned objectives to time, budget and resource forecasts.

• Owns the performance of the CMC matrix team: partners with line managers to appropriately resource the project with the right expertise, and to develop and support the core and extended team members to drive performance and deliver the project.

Voice of CMC for the project:

• Provides the voice of the physical product and supply chain to influence the early medicine development strategies and plans.

• Provides the voice of the project to the CMC matrix team to align the CMC plans with the project intent, and to the CMC functional lines to ensure they have the capability and capacity to deliver.

• Aligns senior leaders across R&D (via governance bodies) on the strategic CMC objectives, plans, and risk mitigation activities for the project and the investments and resources required to deliver these.

• Provides CMC input to due diligence reviews of new asset business development proposals, positioning the CMC opportunities and risks in the context of the proposed medicine and business strategy.

Skills and Competencies

This role requires knowledge, courage and credibility to lead a high performing multi-disciplinary matrix team of CMC experts to develop and deliver the manufacturing process, supply chain, physical medicinal product and regulatory submissions to enable early clinical trials.

An exceptional matrix leader:

• Sets direction, empowers others to take ownership of their activities, monitors progress, knows when and how to intervene to avoid or manage risks and issues, helps remove barriers, holds team members accountable for their delivery and performance on behalf of the team.

• Strong decision-making and influencing skills

• An agile and willing learner

• Creative problem solver: able to analyse and interpret complex situations to provide appropriate innovative solutions and clear strategic direction to others.

• An active and empathetic listener who is aware of own limitations in knowledge, expertise, or experience

• Excellent communicator both verbal and written

A highly credible CMC expert:

• Strong technical knowledge of process, product and analytical development with a broad knowledge of the end to end non-clinical, clinical, and regulatory aspects of developing a medicine.

• Analyses, interprets, and critically evaluates data and information to determine and justify decisions or recommendations

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor of Science in Pharmacy, Biology, Chemistry, Engineering, or related CMC orientated field

• 10+ years of experience in biopharm CMC development, manufacture, supply and regulations

• 2+ years of line and/or matrix leadership experience of multi-disciplinary global teams

• Experience in the pharmaceutical industry with specific experience in a technical CMC function

• Experience creating and defending CMC development strategy, plan and data package for an asset in early development

• Experience leading, developing, coaching and mentoring CMC functional leaders

• Project leadership experience