Director, Clinical Sciences

The Company:

Newleos Therapeutics is a clinical stage neuroscience company co-founded by Longwood Fund and seasoned leaders in CNS drug development. Newleos clinical-stage pipeline was in-licensed from Roche and includes multiple oral small molecules targeting novel mechanisms across a broad range of indications, including generalized anxiety, social anxiety, substance use disorders, and cognitive impairment.

Position Overview:

The Director, Clinical Sciences will be responsible for driving early clinical studies such as experimental medicine, proof of concept, proof of mechanism, and Phase 1 studies in healthy volunteers and patients.

This position is based in Back Bay, reports to the Chief Medical Officer, and supports a weekly hybrid work schedule with 3 days (Mon, Tues, Wed) in office and 2 days (Thurs & Fri) remote.

Responsibilities:

• Become the internal scientific expert in the assigned programs
• Design clinical studies for the early clinical development of assigned programs
• Lead development and writing of study synopsis and provide clinical science input to study protocols
• Provide clinical science input to and be primary clinical science contact for protocol-related documents and processes
• Ongoing review of data during trial conduct and addressing any quality issues identified
• Provide oversight for clinical science activities performed by external vendors (e.g. medical review of data, protocol deviation reporting, site questions etc.)
• Provide responses to relevant questions from health authorities and institutional review boards (IRB)
• Gives clinical and scientific input to and reviews clinical regulatory documents (clinical study reports, investigators brochure, safety reports, submission to health authorities)
• Provide clinical scientific input for final study reports and annual report documentation
• Serve as trouble-shooter and internal key contact on clinical and medical issues and aspects of assigned studies
• Responsible for training and science support to operation colleagues and study site staff
• Speak with clinical site staff to address questions and provide updates
• Represents clinical science in study management teams
• Ensures GCP compliance in assigned tasks
• Contribute to the clinical development plan
• Assist in preparing materials for use in internal and external presentations (e.g. advisory board meetings, steering committee meetings, etc.)

Qualifications:

• Education
  • PhD-/MD-/PharmD-level (or equivalent relevant experience) and five or more years of experience in clinical drug development
• Experience
  • Proven experience in conduct of global clinical trials in early clinical development (experimental medicine, Phase 1b, proof of concept)
  • Extensive experience in development of and writing of clinical trial protocols plus other trial related documents
  • Demonstrated scientific excellence in neuroscience at the interface of pre-clinical and clinical research
  • Confident in responding to ethic committee, regulatory authorities and other external agencies
  • Comfortable providing training to internal and external staff

Newleos Therapeutics is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability or any other status protected under federal, state or local law. All employment is decided on the basis of qualifications, merit and business need.