Director Physician - Early RIA
Overall accountable for the design of the clinical program including all clinical studies up to Ph3ID and overall responsibility for the scientific & medical strategy as a disease area expert. Providing input to the Target Product Profile (TPP) & line of sight for compounds under development.
The Director Physician will deliver to the project team the Medical Scientific strategies of the Clinical Development Plan (CDP). If nominated “Medical Science Director” he/she has accountability for the overall clinical risk:benefit, scientific & value content and delivery of the Medical Science components of the project to time & quality.
Responsible for the design, conduct, monitoring, data interpretation and reporting of individual clinical trials. Ensures projects adhere to Good Clinical Practice and regulatory requirements. Will be responsible for acting as a renowned expert in own disease/drug field.
- Single point accountable leader for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and the product in compliance with GCP
- Designs or manages the implementation of the medical strategy within Clinical Development globally
- Develop clinical evidence for functional relevance of targets in human disease
- Support qualification of pharmacodynamic/disease markers for early assessment of efficacy.
- Ensure that clinical input into the Translational Medicine and development strategies and plans receive adequate peer consultation to assure high scientific quality
- Maintains a high degree of understanding and awareness on new and emerging medical development
- Closely follows medical developments within assigned areas and disseminates new information within Clinical Development to transform trends and emerging data into new plans
- Liaises with the internal and external medical community to follow developments within areas of expertise
- Medical Lead for regulatory communication and preparation of higher level documents
- Ensures internal and external peer review of potential study/programme design
- As available, provide clinical strategic input to in-licensing opportunities
- As available, line management responsibility for medical directors and medical scientists, delivering the performance management and guiding the professional development of direct reports
- Sign off the Study Synopsis/Study Protocol
- Accountable for the Investigators Broschure (IB)
Education, Qualifications, Skills and Experience:
- Graduate of a recognised school of medicine with an M.D. degree or equivalent, PhD preferred but not essential
- >5 years clinical research expertise in relevant therapy area, in designing, monitoring and implementing clinical trials and interpreting trial results
- Specialty training or board eligibility, preferably in Respiratory and/or Inflammation
- Significant leadership experience
- >5 years Drug Development Experience with a thorough understanding of pharmaceutical safety, reporting and surveillance processes
- At least 5 years early clinical translational research expertise and experience, including experience in designing, monitoring, executing and interpreting clinical trials, with understanding of biomarkers, biostatistics and safety reporting
- Proven teamwork and collaboration skills
- Technical (medical and scientific) experience evaluating targets/agents for in -licensing or internal development
- Ability to travel nationally and internationally
- Organize and deliver Advisory Boards with international KOLs
- A clear demonstration of behaviours of:
- Truth seeking rather than success seeking
- Agile responsiveness to scientific data
- Embracing of peer review
- Agnostic to internal-external sourcing
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.