Senior Clinical Pharmacology Specialist

0-2 years

Not Disclosed

Lexington

10 Jan. 3, 2025

Job Description

Job Type: Full Time 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 Title: Clinical Pharmacology Specialist
Location: Lexington, United States
Job Category: Clinical Development

Apply Now

About the Department:

Our East Coast Global Development Hub brings together top minds in life sciences innovation, with facilities in Lexington, MA and Plainsboro, NJ. We support programs spanning from early research to late-stage clinical development. The Novel Modality department is focused on developing innovative treatment modalities such as siRNAs and multiclonal antibodies across a wide range of therapeutic areas, including cardiometabolic and rare diseases. We're building a forward-thinking R&D community centered on collaboration, partnerships, and cutting-edge research in various innovative modalities. Combining the speed and agility of biotech with the quality and resources of a large pharmaceutical company, our hub is committed to developing new medicines and improving human health. Are you ready to make a difference?

The Position:

The Clinical Pharmacology Specialist will be accountable for driving the clinical pharmacology strategy for phases 1-4 in clinical development programs, including dosage and administration strategy. This includes designing clinical pharmacology trials, ensuring high scientific quality in related documents, and providing expert input throughout the process. This highly cross-functional role may also involve some travel.

Key Responsibilities:

Clinical Pharmacology Strategy (Phase 1-4):

Develop and implement clinical pharmacology strategies for projects, aligning with global teams and business units.
Oversee the clinical pharmacology section of the Product Development Plan and ensure scientific quality in related documents, including Clinical Pharmacology Summaries, Investigator's Brochure, and Health Authority interactions.
Attend meetings with regulatory authorities, advisory boards, and governance bodies to negotiate clinical pharmacology aspects.

Dosage and Administration Strategy:

Develop dosage and administration strategies, considering pharmacokinetics (PK) and pharmacodynamics (PD) data.
Maintain an overview of how activities (CMC, clinical, non-clinical, etc.) impact dosage decisions and ensure studies are aligned with overall clinical pharmacology and dosing strategies.

Scientific and Pharmacology Aspects of Trials:

Responsible for the design and scientific integrity of clinical pharmacology trials.
Ensure trials align with the clinical pharmacology strategy, incorporating model-informed drug development and innovative trial designs.
Provide scientific input during clinical trial applications, ensuring the inclusion of relevant pharmacology considerations.

Knowledge Sharing and Expertise Development:

Act as an expert in clinical pharmacology, PK/PD, and dosage administration.
Contribute to the development of your competencies in clinical pharmacology.
Share knowledge with internal teams and external stakeholders, including key opinion leaders and advisory boards.

Physical Requirements:

Occasional travel required, both domestically within the U.S. and internationally (headquarters located in Denmark).

Qualifications:

PhD with 0-2 years of experience, or PharmD with 2+ years of experience, or Master’s degree with 5+ years of relevant experience.
Expert knowledge in clinical pharmacology.
Solid experience in strategic planning for clinical development within the pharmaceutical industry.
Extensive expertise in managing clinical pharmacology projects and designing clinical trials.
Knowledge of drug development processes and therapeutic areas.

Why Join Novo Nordisk:

At Novo Nordisk, we aspire not only to be the best company in the world but the best company for the world. Join a diverse and inclusive environment where talented individuals from varied backgrounds collaborate to make a global impact. Together, we’re life-changing.

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Senior Clinical Pharmacology Specialist

Job Description

Apply Now

About the Department:

The Position:

Key Responsibilities:

Clinical Pharmacology Strategy (Phase 1-4):

Dosage and Administration Strategy:

Scientific and Pharmacology Aspects of Trials:

Knowledge Sharing and Expertise Development:

Physical Requirements:

Qualifications:

Why Join Novo Nordisk:

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