Director, Clinical Pharmacology

Society for Conservation Biology; Boston (MA); Hybrid; USD 120,000 - 150,000; Full time

Job summary

A leading company in Boston is seeking a Clinical Pharmacologist to lead clinical pharmacology strategies in CNS drug development. This role offers a unique opportunity to impact a dynamic startup environment with a hybrid work schedule. The ideal candidate will possess a PhD, PharmD, or MD and have significant industry experience.

Qualifications

• 5+ years of industry experience in clinical pharmacology, preferably in CNS drug development.
• Strong knowledge of regulatory guidelines (FDA, EMA) for CNS drugs.

Responsibilities

• Design, plan, and oversee clinical pharmacology components of drug development programs.
• Collaborate with cross-functional teams including Clinical Development and Regulatory.

Skills

Communication

Problem Solving

Education

PhD in Clinical Pharmacology

PharmD

MD

Job description

Job Description

Salary:

Competitive salary commensurate with experience.

The Company:

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

Position Overview:

We are seeking a highly motivated Clinical Pharmacologist with a strong background in CNS drug development to join our team in Boston. The successful candidate will lead the design and execution of clinical pharmacology strategies from preclinical to clinical stages. This is a unique opportunity to make a significant impact in a dynamic startup environment.

This position is based in Back Bay, reports to the Sr. Vice President, Clinical and Technical Operations, with a hybrid work schedule: 3 days in-office (Mon-Wed) and 2 days remote (Thurs-Fri).

Responsibilities:

1. Design, plan, and oversee clinical pharmacology components of drug development programs.
2. Collaborate with cross-functional teams including Clinical Development, Preclinical, Regulatory, Clinical Operations, and CMC to integrate PK, PD, and exposure-response modeling into development strategies.
3. Interpret and analyze PK/PD data to support dose selection and optimization.
4. Author key sections of regulatory submissions (e.g., IND, IB, CTA).
5. Interface with regulatory authorities and present clinical pharmacology data to support trial design and progression.
6. Stay informed on emerging trends and regulatory expectations in CNS clinical pharmacology.

Qualifications:

1. PhD, PharmD, or MD with specialization in Clinical Pharmacology or related field.
2. 5+ years of industry experience in clinical pharmacology, preferably in CNS drug development.
3. Experience designing and executing clinical pharmacology studies.
4. Strong knowledge of regulatory guidelines (FDA, EMA) for CNS drugs.
5. Experience with PK/PD modeling and interpretation of CNS biomarker data.
6. Excellent communication skills and ability to work collaboratively in a startup environment.
7. Proactive, flexible, and problem-solving mindset.

Preferred Qualifications:

1. Experience in early-phase neuroscience drug development.
2. Knowledge of neuropharmacology and CNS biomarkers.
3. Experience in startups or small biotech companies.

Equal Opportunity:

Newleos Therapeutics is an Equal Opportunity Employer committed to diversity and inclusion. We do not discriminate based on race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status, disability, or any other protected status. Employment decisions are based on qualifications, merit, and business needs.