Global Development Senior Medical Director, Hematology Oncology
AstraZeneca · Cambridge, MA · 1 wk ago
Full-time
About the role
This Senior Medical Director role is posted in Gaithersburg, United States although we are willing to consider candidates in these Hematology locations: Boston, Massachusetts; South San Francisco, California; Barcelona, Spain.
Responsibilities
- Supports or leads interactions with global medical affairs, marketing companies, commercial, in collaboration with GCH/GCPL to ensure cross functional input into protocols.
- Ensures the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as AZ SOPs regarding safety.
- Works cross-functionally and lead all aspects of the design and implementation of clinical hemato-oncology projects, as leader of our Clinical Product Team (CPT) and member of the Clinical Sub-Team (CST).
- Ensures the scientific and medical content of all clinical programs is scientifically and clinically rigorous.
- Provides expert clinical input to influence the study design via collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders, such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements, and meets the strategic program objectives.
- Reviews potential in-licensing candidates and presents recommendations to Senior Management groups.
- Contributes and supports Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
- Mentors the development of less experienced members of the clinical team, and may involve direct line management of other physicians or scientists.
Requirements
- MD or international equivalent is required.
- Medical hemato-oncology clinical training is required.
- Minimum of 4 years of relevant experience.
- Board Certification is preferred.
- Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
- Possesses general knowledge of medical monitoring, Regulatory approval process in relevant countries, pharmaceutical industry/R&D operations, and marketing and commercial fundamentals.
Qualifications
- Demonstrates a proven ability to both independently complete, and lead peers in completion in components of complex plans, related documents, appropriate methodologies, measures, analytical plans and evaluation tools.
- Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally.
Skills
- Collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca.
Benefits
- Short-term incentive bonus opportunity.
- Equity-based long-term incentive program (salaried roles).
- Retirement contribution (hourly roles).
- Commission payment eligibility (sales roles).
Pay
The annual base pay ranges from $288,059.20 - 432,088.80.
Schedule
At-will position.