Manager - Clinical Pharmacology

7+ years

Not Disclosed

Lexington United States

10 Feb. 13, 2025

Job Description

Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Manager, Clinical Pharmacology

Location: Lexington, United States
Job Category: Clinical Development

About the Department

Our East Coast Global Development Hub in Lexington, MA, and Plainsboro, NJ, brings together top talent in life science innovation. We support programs from early research through late-stage clinical development, combining biotech speed with pharmaceutical resources and stability. Our goal is to advance cutting-edge research across multiple innovative modalities and therapeutic areas to develop new medicines for patients.

The Position

The Manager, Clinical Pharmacology is responsible for clinical pharmacology strategy across Phase 1-4 of clinical development programs. This role ensures proper dosage and administration strategies, provides scientific leadership in clinical pharmacology trials, and serves as an expert in PK/PD (pharmacokinetics/pharmacodynamics). The role is highly cross-functional and may require occasional travel.

Key Responsibilities

1. Clinical Pharmacology Strategy (Phase 1-4)

Develop and align clinical pharmacology strategy with Global Project Teams (GPTs) and Medical & Science Teams (MSTs).
Lead the development of Product Development Plans from a clinical pharmacology perspective.
Design clinical pharmacology trials to meet strategic goals.
Ensure scientific quality in Clinical Pharmacology Summaries, Investigator’s Brochures, and regulatory interactions.
Represent clinical pharmacology at regulatory meetings, advisory boards, governance boards, investigator meetings, and safety committees.

2. Dosage and Administration Strategy

Develop and align dose setting and dosing regimens with cross-functional teams.
Maintain an overview of:
- PK/PD properties and commercial dosage aspirations.
- CMC (Chemistry, Manufacturing, and Controls), device, and non-clinical/clinical activities affecting dosing.
- Available and future studies supporting dose selection.

3. Scientific & Pharmacology Aspects of Clinical Trials

Serve as scientific lead for clinical pharmacology protocol outlines and trial designs.
Ensure quality, innovation, and model-informed drug development (MIDD) approaches in trials.
Balance cost-benefit of planned assessments and align with stakeholders.
Provide input on regulatory submissions, health authority interactions, and ethics committee responses.
Act as a scientific contact for investigators.
Lead trial safety groups for First Human Dose (SAD/MAD) studies.
Oversee data assessment, evaluation, and interpretation.

4. Clinical Study Reports & Publications

Ensure scientific integrity in clinical study reports.
Present data internally for decision-making and externally through publications and conferences.

5. Knowledge-Sharing & Leadership

Develop expertise in clinical pharmacology, PK/PD, and dosing strategies.
Interpret and analyze external and competitor data.
Support due diligence evaluations.
Build and maintain a network of investigators, key opinion leaders (KOLs), and research scientists.
Actively contribute to knowledge-sharing across projects and teams.

Physical Requirements

Occasional domestic and international travel, including to Novo Nordisk’s headquarters in Denmark.

Qualifications

Education:

PhD with 2+ years of experience.
PharmD with 4+ years of experience.
Master’s degree with 7+ years of experience in a relevant field.

Experience & Skills:

Expert knowledge in clinical pharmacology.
Experience in strategic clinical development planning in the pharmaceutical industry.
Strong expertise in clinical pharmacology trial design and drug development processes.
Relevant therapeutic area expertise.

Equal Opportunity Employer

Novo Nordisk is committed to diversity, equity, and inclusion in hiring. We provide equal employment opportunities regardless of race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other legally protected characteristic.

Accommodation Requests

If you need assistance or accommodation to apply, please call 1-855-411-5290 (for accommodation requests only).

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