Job Description
Job DescriptionSalary:
The Company:
Newleos Therapeutics is an innovative, fast-growing biotech startup dedicated to transforming the treatment of mental health conditions through evidence-based interventions and novel therapeutics. Our current focus includes programs in Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Substance Use Disorders (SUDs). We aim to accelerate the development of next-generation therapies by combining clinical rigor with cutting-edge clinical science.
Position Overview:
We are seeking a Medical Director to provide clinical and scientific leadership for one of our core programs in GAD, SAD, or SUD. This role is ideal for a psychiatrist or physician-scientist with experience in clinical trials who is eager to contribute to early-stage development, help shape trial strategy, and collaborate with cross-functional teams in a startup environment.
The Medical Director will work closely with the Chief Medical Officer (CMO), Clinical Operations, Regulatory Affairs, and Clinical Pharmacology teams to ensure clinical excellence, safety oversight, and scientific integrity across program activities.
This position is based in Back Bay, reports to the CMO, and supports a weekly hybrid work schedule with 3 days (Mon, Tues, Wed) in the office and 2 days (Thurs & Fri) remote.
Responsibilities:
- Serve as medical lead for one assigned clinical program (GAD, SAD, or SUD).
- Provide medical and scientific input into the design, execution, and interpretation of clinical trials.
- Contribute to the development of clinical protocols, investigator brochures, and regulatory submissions.
- Monitor trial conduct and patient safety, including review of adverse events and emerging efficacy data.
- Participate in clinical study team meetings, investigator meetings, and interactions with external key opinion leaders (KOLs).
- Support data analysis, interpretation, and publication of clinical trial results.
- Collaborate with internal and external partners, including CROs, investigators, and scientific advisors.
- Stay current with scientific and therapeutic developments in psychiatry.
- Contribute to the strategic development of future programs and new indications.
Qualifications:
- MD or equivalent medical degree.
- Minimum 25 years of clinical experience, with at least some exposure to clinical research or clinical trials (industry, academic, or CRO setting).
- Strong interest in psychiatry, anxiety disorders, and substance use disorders.
- Excellent communication skills and ability to collaborate in a fast-paced, cross-functional team environment.
Preferred:
- Board-certified or board-eligible in Psychiatry or Neurology
- Experience in clinical development or medical monitoring for psychiatric indications.
- Previous involvement in early-phase trials (Phase III) and interactions with regulatory agencies.
- Strong analytical and problem-solving skills; ability to translate scientific insights into clinical strategy.
- Entrepreneurial mindset and comfort working in a startup or small-company environment.
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.