Clinical Program Director, Early CVRM Clinical Development
This position can be based in Gaithersburg, MD, US; Cambridge, UK; or Gothenberg, Sweden offices.
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
The Clinical Program Director within the Cardiovascular, Renal & Metabolic (CVRM) team is a clinical program leader ensuring that each assigned clinical program is delivered to time, quality and cost. The role provides strategic input and final feasibility view into design of the clinical program and plays a key role in the work required to determine possible program design options, mainly in early clinical development programs or as delegated from the Senior Director/Global Head. The focus is across the program level collaborating with the Development Operations (Dev Ops) organization, Project Team counterparts, and all other functions that are key to the development of a compound.
- In collaboration with the Senior Medical Director (SMD), is accountable for translating science into crisp and robust clinical development plans, including operational design options.
- In collaboration with the Senior Medical Director (SMD), is accountable for the clinical program strategy, including innovative approaches to delivery, e.g., new delivery platforms and technology to ensure patient engagement, recruitment and retention.
- Responsible for leadership and oversight of program strategy activities within each assigned program.
- Responsible for providing strategic and operational input to cross-functional program development plans and accountable for cross-functional leadership roles as delegated from the Project Team, e.g., leadership of cross-functional product development team activities. Provide expert clinical operational input into: Target Product Profile (TPP), Clinical Development Plan (CDP), Study Synopsis, Clinical Study Protocol, Clinical Study Report, IB, briefing documents, etc., to ensure seamless delivery of programs through effective collaboration.
- Accountable for collaborating with Dev Ops on the process to ensure timely selection of an appropriate delivery model including selection of external providers for program/study specific tasks as well as operational management and oversight of the external providers.
- Responsible for development and management of contingency risk plans within each assigned clinical program to ensure operational delivery to quality, budget and timelines, including management of issue escalation and resolution.
- Ensure consistent quality practices in alignment with highest ethical standards, GCP, ICH Guidelines, compliance with internal SOPs, local regulations and laws, etc.
- Contribute to scientific interpretation of clinical data, including review of CIMs, TLFs, etc.
- Responsible for ensuring timely compliance with company-wide governance controls.
- Contribute to driving best practices and support process-related improvements and workstreams, including alignment with OFR.
- Bachelor of Science/Arts degree in related discipline, preferably in medical or biological science. Advanced degree is preferred.
- At least 15 years global drug development experience demonstrated in a variety of related roles.
- Program level experience across the product life cycle and across multiple therapeutic areas (strongly prefer Cardiovascular, Renal and/or Metabolism), with experience in global drug development
- Leadership and strategic influencing skills with ability to influence broadly within and outside the organisation, motivate team members, and build cross-functional teams.
- Proven ability to develop programmes to meet business goals and to assess business risk versus potential value; ability to understand global business requirements.
- Experience of clinical programme management and use of project management techniques in complex projects, including resourcing and financial management.
- Strategic influencing skills with ability to influence broadly within and outside the organisation, motivate team members and build cross-functional teams.
- Experience in clinical trial methodology with ability to deliver differentiated options based on sound knowledge of operational delivery.
- Proven ability in problem solving and issues management that are solution focused.
- Extensive and proven experience in driving operational delivery to timelines, cost and quality.
- Proven experience of leading delivery through collaboration within globally matrixed teams, including internal organization and external providers.
- Experience in selection and oversight of external providers and development/review of contracts.
- Strong collaborative communication skills including ability to engage with diverse client base and manage through conflict
- Strategic skills including high level of creativity innovation, and problem solving with ability to manage effectively through ambiguity
- Willingness to travel both domestically and internationally
- Focus on patient centricity
- Truth seeking rather than success seeking
- Agile responsiveness to scientific data
- Embracing of peer review
- Agnostic to internal-external sourcing
- Possess positive change management skills, at all levels (individually, team and the business), seeing change as opportunity to improve performance and add value to the business
- Programme management qualification/certification. Experience in variety of organisations and countries
- At least 12 years clinical operations experience
Next Steps – Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.