Senior Director Medical Affairs
4 weeks ago
Locations: Marlborough, MA | Arden Hills, MN
Work Model: Hybrid
About the role:
This position is responsible for providing medical expertise, support, and guidance to the Endoscopy Division in the areas of quality and safety for all endoscopy products marketed worldwide and for all phases of clinical study of endoscopic devices. This role reports directly to the Chief Medical Officer of Endoscopy, manages a team of experts in medical safety, and collaborates both with the multifunctional leaders within the Division as well as with healthcare professionals who use Boston Scientific devices.
Your responsibilities will include:
- Managing a team of medical safety experts to monitor the performance off all BSC Endoscopy products worldwide, both through commercial activities and clinical trials
- Serve as the voice of the physician and patient when critically evaluating a safety event
- Provide detailed medical guidance to internal and external groups including project teams, cross-functional units, investigators, and regulatory agencies
- Provide hands-on operational support to teams in clinical trial planning, protocol development, investigator selection, training of internal and external personnel, medical monitoring for trial safety, data analysis/interpretation, and quality control
- Deliver direct physician support to quality assurance group for risk management and post market activities.
- In partnership with the Endoscopy Division’s Global Clinical Trials team, write and edit clinical and scientific reports for regulatory submission and scientific communication
- Cultivate relationships with influential thought leaders in the medical community
- Attend and participates in select regional, national, and international meetings
- Review and approves product educational and promotional materials
Required qualifications:
- Medical degree (MD or DO); current board certification in gastroenterology; holds a valid, unrestricted, and unchallenged medical license
- 10+ years of clinical practice in therapeutic endoscopy (including ERCP and EUS)
- Knowledge of clinical trial design and biostatistics
Preferred qualifications:
- Excellent communication skills in collaborating with scientific and non-scientific groups
- Demonstrated ability to write and publish peer-reviewed manuscripts and technical reports
- Able to speak credibly with expert endoscopists to gain feedback about the performance of a medical device
- Demonstrated ability to effectively manage a team while supporting and promoting its members
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