Associate Medical Director, Clinical Development Sciences
Date de publication :
06 novembre 2024Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Boston
Job Duties & Responsibilities
- Function as the Medical expert for the clinical study team
- Protocol development from study concept to final protocol
- Oversight of global clinical trial team(s) on assigned program(s)
- Collaborate on, or lead where appropriate, the preparation of clinical study related documents
- Prepare for and coordinate Investigator meeting planning and execution and/or on-site initiation meetings
- Liaise with other functions to enable quality clinical study execution
- Monitor, clean, analyze and review safety and efficacy data to establish the presence or absence of trends and follow up as appropriate
- Presentation at academic congresses, investigator meetings and advisory meetings
- Development of medical content for regulatory documents and responses, including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents
- Independent data monitoring committee activities
Essential Qualifications
- MD
- Previous history executing and overseeing clinical trials
- Safety medical monitoring
- Protocol development experience
- Regulatory experience
- Basic statistical knowledge
- Excellent written / oral communication skills
- Ability to think strategically
- Willingness to take on new responsibilities
- Interest in career progression and ability to take on additional responsibilities
Preferred Qualifications
- Internal Medicine, Cardiology
- History of academic clinical or basic science research
- Publication in peer reviewed journals
- Industry experience a plus but not required
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 authorization and employment eligibility verification requirements.