(Senior) Director, Clinical Pharmacology

Newleos Therapeutics; Boston (MA); Hybrid; USD 174,000 - 275,000; Full time

Job summary

An innovative clinical-stage neuroscience company seeks a highly motivated Clinical Pharmacologist to lead clinical pharmacology strategies. This role offers a unique opportunity to make a significant impact in a dynamic startup environment. With a focus on CNS drug development, you will design and execute clinical strategies, partner with cross-functional teams, and interface with regulatory authorities. If you are passionate about advancing neuroscience therapies and thrive in a collaborative setting, this position is perfect for you. Join a forward-thinking team dedicated to transforming lives through cutting-edge research and development.

Qualifications

• 5+ years of experience in clinical pharmacology with a focus on CNS.
• Strong understanding of regulatory expectations for CNS drugs.

Responsibilities

• Design and oversee clinical pharmacology components of drug development.
• Analyze PK/PD data to support dose selection and optimization.

Skills

Clinical Pharmacology

CNS Drug Development

PK/PD Modeling

Regulatory Guidelines

Collaboration Skills

Education

PhD, PharmD, or MD

Job description

(Senior) Director, Clinical Pharmacology

(Senior) Director, Clinical Pharmacology

3 days ago Be among the first 25 applicants

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Talent Strategy Leader | Partnering with Biotechs & VCs to Build High-Impact Teams

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:

We are seeking a highly motivated Clinical Pharmacologist with a strong background in CNS drug development to join our growing team in Boston. The successful candidate will play a key role in the design and execution of clinical pharmacology strategies from preclinical development through clinical trials. This is a unique opportunity to make a significant impact in a dynamic, fast-paced startup environment.

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

Responsibilities:

• Design, plan, and oversee clinical pharmacology components of drug development programs.
• Partner with cross-functional teams including Clinical Development, Preclinical, Regulatory, Clinical Operations and CMC to integrate pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response modeling into overall development strategy.
• Interpret and analyze PK/PD data to support dose selection and optimization.
• Author key clinical pharmacology sections of regulatory submissions (e.g., IND, IB, CTA).
• Interface with regulatory authorities and present clinical pharmacology data to support clinical trial design and progression.
• Maintain awareness of emerging trends, literature, and regulatory expectations in CNS clinical pharmacology.

Qualifications:

• PhD, PharmD, or MD with specialization in Clinical Pharmacology or a related discipline.
• 5+ years of industry experience in clinical pharmacology, ideally with a focus on CNS drug development.
• Demonstrated experience designing and executing clinical pharmacology studies.
• Strong understanding of regulatory guidelines and expectations (e.g., FDA, EMA) for CNS drugs.
• Experience with PK/PD modeling, interpretation of CNS biomarker data, and translational pharmacology.
• Excellent written and verbal communication skills; ability to work collaboratively in a startup team environment.
• Entrepreneurial spirit, flexibility, and a proactive, problem-solving mindset.

Preferred Qualifications:

• Experience in early-phase neuroscience drug development.
• Familiarity with neuropharmacology and CNS-specific biomarkers.
• Experience working in or with startups or small biotech companies.

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.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

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