Senior Clinical Program Director, Clinical Program Management, Clinical Operations

Location: Waltham, MA

Introduction to role

The Senior Clinical Program Director (SrCPD) is accountable for the overall delivery of the clinical program to time, cost, and quality and is the leader of the Clinical Program Team (CPT). The SrCPD will work closely with core CPT members to ensure that the clinical strategy and deliverables for the clinical program are delivered to the Global Project Team (GPT). This role provides strategic oversight and feasibility input into the design of the clinical program and plays a key role in determining possible program design options. The SrCPD focuses on program-level collaboration with CPT members, eGPT colleagues, and other key functions essential to the development of a compound. The SrCPD is expected to be a highly experienced drug developer with organizational understanding and influence. They will drive and guide the CPT and its functions, enhancing teamwork, productivity, and quality. As the CPT Leader, the SrCPD will influence aspects related to the clinical development plan from pre-Clinical to Commercial stages with other core CPT members. The role will establish and monitor best practices and be responsible for quality goal setting for CPT deliverables.
 

Accountabilities

Lead the Clinical Program Team (CPT) and oversee clinical program strategy activities and deliveries within assigned programs, ensuring innovative approaches to program delivery.

Translate science into clear clinical development plans.

Provide efficient and effective program management of all CPT deliverables, including project strategy, design, and delivery of CPT-driven programs/studies on time, on budget, and with quality.

Provide strategic and operational input to cross-functional program development plans and take on cross-functional leadership roles as delegated from the eGPT.

Coordinate and actively present clinical components at governance reviews.

Ensure initial feasibility assessment and early country and site engagement to optimize clinical program delivery.

Develop and manage contingency risk plans within each assigned clinical program, including issue escalation and resolution.

Accurately forecast, maintain, and monitor budgets to baseline, manage clinical program resourcing, scenario planning, and overall timelines for trials within assigned programs.

Ensure consistent quality practices in alignment with ethical standards, GCP, ICH Guidelines, compliance with internal SOPs, local regulations, and laws.

Contribute to driving best practices, support process-related improvements and workstreams, and ensure timely compliance with Company governance controls.

Provide mentorship and support people development as required.

Essential Skills/Experience

Master/PhD of Science degree in natural sciences or medicine (advanced degree is preferred)

At least 10 years global pharmaceutical drug development and leadership experience demonstrated in a variety of roles and at least 5 years clinical development experience

Proven ability to apply strategic thinking and develop clinical programmes to meet business goals and to assess business risk versus potential value

Proven ability to lead teams in dynamic environments with a high demand on pro-active scenario planning

Verified ability in problem solving and issues management that are solution focused

Proven experience of leading delivery through collaboration within globally matrixed teams, including internal organization and external providers and drive delivery to timelines, cost and quality

Significant experience of program management and use of project management techniques in complex projects, including resourcing, financial management and business case development

Strong strategic influencing skills; ability to influence broadly within and outside the organization

Excellent communication skills; proven teamwork and ability to work collaboratively across a wide range of disciplines and a track record of planning and delivery success
 

Desirable Skills/Experience

Programme management qualification/certification. Experience in variety of organisations and countries

At least 10 years clinical development experience

Experience across the product life cycle and ideally across multiple therapeutic areas
 

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
 

Join the team that follows the science unlike anywhere else. This is the place for curious minds. Dig deep into the biology of complex disease and uncover breakthroughs. Our belief powers us to push the boundaries. As we improve success rates, we keep moving forward. Celebrating both successes and failures along the way. We're investing to enhance our understanding of disease as we work towards creating the next generation of therapeutics and pioneering new approaches to better predict clinical success. Always advancing our scientific knowledge and helping to shape the future of healthcare for the greatest and swiftest impact on disease.
 

Ready to make a difference? Apply now!

Date Posted

10-Jan-2025

Closing Date

26-Jan-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.