join our team
Are you looking for a positive and stimulating work environment? Joining Amolyt Pharma means choosing a fast growing, international and pioneering company committed to providing innovative treatments to patients suffering from rare endocrine and metabolic diseases. We are always looking for passionate and talented individuals to join our dedicated team to help us achieve our mission.
While there are no current openings, be sure to check back often to see what new jobs are posted.
Explore our open positions below:
As clinical lead, the candidate will be responsible for scientific and medical/clinical oversight of clinical trials. This role will provide medical/clinical input into the design and conduct of clinical trials as well as assessment and interpretation of clinical data.
This role reports to the VP, clinical development and regulatory affairs
- Support the development of Clinical Development Plans, including target diseases/patient populations
- Provide medical/clinical leadership in the design and conduct of clinical trials, including drafting of protocols and respective amendments, informed consent forms, and other supporting documents
- Provide medical support for clinical trials and act as medical monitor
- Lead medical/clinical reviews, assessment and interpretation of efficacy and safety data to ensure that the data are presented with the appropriate medical interpretation
- Provide medical/clinical input into Investigator Brochure, safety reports, including SAE narratives and analysis of similar events, Clinical Study Reports and scientific publications
- Contribute to CRO, site and investigator training
- Contribute to developing and maintain relationships with the medical community, investigators and Key Opinion Leaders
- Responsible for medical/clinical monitor input into the development and implementation of standard operating procedures for all aspects of Adverse Event report handling, aggregate reporting and assuring compliance with global and local regulatory requirements
- Responsible for implementing alignment across policies/procedures and ensuring that data generated are compliant with FDA and ICH guidelines and GCP
- MD (experience in endocrinology and metabolism a plus) or PhD in relevant discipline
- 8+ years’ experience in drug development or clinical research (biotech or pharmaceutical industry preferred)
- EU experience, US experience a plus
- Fluent in oral and written English
- Understanding of local and global drug safety regulations and processes and clinical trial oversight, including global GCPs
- Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders
- Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing
Posted: October 8th, 2020