About Prevail Therapeutics
Prevail is a New York City-based biotechnology company focused on developing novel gene therapies for Parkinson’s disease and other genetically-defined neurodegenerative diseases. Prevail is based in the Alexandria Center for Life Science.
The clinical scientist will be an integral member of the clinical team and support programs both in the clinic and preparing to enter the clinic. This person will provide cross-functional support to programs by working closely the Medical, Operational, Regulatory, Biomarker, and Technical groups.
We are looking for an enthusiastic, self-motivated, hands-on scientist who is capable of performing multiple duties inherent in clinical development and comfortable working in an open environment.
As an early hire at a new company, you will have exposure to senior management, to all activities at Prevail, and you will be influential in championing and developing our culture. Our employees are expected to function with a high degree of independence in a fast-paced startup company, while working collaboratively within a multidisciplinary team that is dedicated to the development of new therapies for neurodegenerative diseases.
- Support development of clinical development plans, protocols, biomarker and regulatory strategies
- Responsible for providing analytical support for clinical trials (with an emphasis on key safety and efficacy data, including biomarkers).
- Responsible for providing input and critical review of vendor specifications, data entry and data review plans (including medical monitoring), analyzing and interpreting findings and providing preliminary assessments and recommendations
- Support authoring and review of key clinical documents such as pre-INDs/INDs, protocols, IBs, ICs, charters
- Perform literature reviews and present summary of findings
- Attend key scientific meetings and interact with thought leaders
- Support preparations for advisory board meetings and external data monitoring committee meetings
- Support development of scientific papers and overall communication plans
- Collaborate with clinical project management in providing oversight and management of CROs, contract staff and vendors supporting clinical activities
- Minimum 3 years’ experience working in industry (Pharma/biotech)
- PhD or Pharm.D, or equivalent, preferably with Neuroscience background
- Experience in clinical development activities particularly in early phases, including developing clinical development and regulatory plans, writing core clinical documents (protocol/IB/IC/IND, medical monitoring, managing advisory boards, interacting with CROs
- Experience in gene therapy is preferable
- Strong attention to detail and the ability to manage multiple tasks
- Ability to work individually, within a multi-disciplinary team, as well as with external vendors
- Excellent written and communication skills
We offer competitive compensation and benefits, including paid time off, health insurance, life insurance and flexible spending accounts. Prevail is an Equal Opportunity Employer.
Please apply by sending your CV to email@example.com.