Clinical Program Director, Early CVRM Clinical Development

The Senior Clinical Program Director 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). You will be required to work closely with the core CPT members to ensure that the clinical strategy and deliverables for the clinical program are delivered to the Global Project Team (GPT).

The role provides strategic oversight and feasibility input into the design of the clinical program and plays a key role in the work required to determine possible program design options. The focus is across the program level, collaborating with CPT members, GPT colleagues and all other functions that are key to the development of a compound. The SrCPD is expected to be a highly experienced drug developer and have organizational understanding and influence.

You will drive and guide the CPT and each of its functions and enhance teamwork, productivity and depth of quality. This person will be responsible for driving the clinical strategy, implementation and forward planning. The SrCPD, as the CPT Leader, will drive/guide the GPT in aspects related to the clinical development plan and influence from pre-Clinical to Commercial with other core CPT members.

The role will establish and monitor best practices and be responsible for quality goal setting for the CPT deliverables.

Location:

Cambridge, MA or Gaithersburg, MD

• Accountable for leading the CPT and its oversight of clinical program strategy activities and deliveries within assigned programs and for ensuring the implementation of innovative approaches to delivery of the clinical program
• Accountable for leading the translation of science into crisp clinical development plans
• Accountable for providing efficient and effective program management of all CPT deliverables, including project strategy, design and delivery of CPT driven program/studies to time, on budget and with quality
• Accountable for providing strategic and operational input to cross-functional program development plans and be accountable for cross-functional leadership roles as delegated from the GPT
• Accountable for ensuring governance preparation and ensuring operational review. Accountable for coordinating and actively presenting the clinical components at the reviews
• Accountable for ensuring initial feasibility assessment and early country and site engagement to optimize clinical program delivery
• Accountable for developing and managing contingency risk plans within each assigned clinical program, including management of program issue escalation and resolution
• Accountable for accurate budget forecasting, and maintenance, and monitoring to baseline, clinical program resourcing, scenario planning, plus overall timelines for trials within assigned program, including setup and maintenance within Company systems
• Ensure consistent quality practices in alignment with highest ethical standards, GCP, ICH Guidelines, compliance with internal SOPs, local regulations and laws, etc
• Contribute to driving best practices and support process-related improvements and work streams, and ensuring timely compliance with Company governance controls
• Provide mentorship and support people development as required

• Master/PhD of Science degree in natural sciences or medicine (advanced degree is preferred)
• At least 10 years of 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 programs 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…