Executive Medical Director – Rheumatology – Early R&I Clinical Development
| Company | AstraZeneca |
|---|---|
| Location | Boston, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | PhD, MD |
| Experience Level | Senior, Expert or higher |
Requirements
- Advanced degree in a relevant scientific discipline (MD and/or PhD)
- 10+ years of experience in clinical development in relevant immunology indications, with background working in early clinical development (first in human through Ph2b)
- Demonstrated track record in leading cross-functional teams and delivering results
- Outstanding verbal and written communication skills, in addition to excellent organizational skills
- Understanding of the entire drug development process, including clinical and non-clinical study design and execution
- Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules
- Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world
- Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals
- Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication
- Excellent analytical, problem-solving and strategic planning skills
- Ability to thrive in a fast-paced environment
Responsibilities
- 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
- Provide impactful medical strategy and clinical expertise to Research, Translational Medicine, Early and Late stage Clinical Development and Commercial Partners, including in the development of therapeutic area strategy
- Closely follow medical developments within assigned areas and disseminate new information within Clinical Development and wider organization, to transform trends and emerging data into agile clinical plans
- Work closely and collaborate across early and late R&I clinical development, partner functions and wider AZ organization to ensure design and delivery of clinical development plans with high quality and speed
- Represent early R&I clinical development to external stakeholders, including investigators, key external experts, governmental/policy groups and community/patient advocacy groups
- Medical Lead for regulatory communication and preparation of higher level documents
- Ensures internal and external peer review of potential study/program design
- Support qualification of pharmacodynamic/disease markers for early assessment of efficacy
- Provide clinical strategic input to in-licensing opportunities
Preferred Qualifications
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No preferred qualifications provided.