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Head Of Nonclinical Development Jobs (NOW HIRING)

GondolaBio

Vice President, Development

Biomarker Sciences & Development • Lead biomarker identification and the nonclinical-to-clinical biomarker strategy and execution. • Drive clinical biomarker qualifications to support proof of ...

Life Sciences WA

$210K - $290K/yr

Reporting to Global Head of Data Science, this role partners closely with Executive Management, Clinical Development, Data Sciences, Regulatory Affairs, and Commercial Leadership to position ...

Laekna LLC

Head of Business Development

Dallas, TX · On-site

Head of BD Function: Corporate and Business Development Report To: CEO Location: US About Laekna ... On the other hand, the company's self-developed innovative drugs will soon enter clinical ...

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Head Of Nonclinical Development information

What does a head of nonclinical development do?

A Head of Nonclinical Development leads and oversees all nonclinical research and development activities for pharmaceutical or biotechnology products. This includes the design, execution, and interpretation of preclinical studies that assess the safety, pharmacology, and toxicology of new drug candidates before they enter human trials. They ensure compliance with regulatory requirements, manage teams of scientists, and collaborate with other departments to support successful drug development. Their role is critical for progressing new therapies from the laboratory to clinical testing.

What are the key skills and qualifications needed to thrive as a head of nonclinical development?

To thrive as a Head of Nonclinical Development, you need deep expertise in toxicology, pharmacology, and drug development processes, typically backed by an advanced degree (PhD, PharmD, or equivalent) and significant industry experience. Familiarity with regulatory submission systems, GLP standards, and data analysis software is essential. Strong leadership, project management, and cross-functional communication skills set outstanding candidates apart. These skills ensure effective oversight of nonclinical studies, regulatory compliance, and successful progression of drug candidates through development pipelines.

What are some common challenges faced by a head of nonclinical development when managing cross-functional teams?

A Head of Nonclinical Development often oversees diverse teams including toxicology, pharmacology, and bioanalytical groups. One common challenge is aligning objectives and timelines across these specialized functions, especially when coordinating with regulatory, clinical, and CMC departments. Effective communication and prioritization are crucial to ensure studies are designed and executed in compliance with evolving regulatory standards. Building a collaborative culture and proactively addressing resource constraints can help mitigate delays and maintain project momentum.

What is the difference between Head Of Nonclinical Development vs Senior Nonclinical Scientist?

AspectHead Of Nonclinical DevelopmentSenior Nonclinical Scientist
ResponsibilitiesOversees entire nonclinical development strategies, manages teams, and directs project pipelines.Conducts nonclinical studies, analyzes data, and supports project teams under supervision.
Required CredentialsAdvanced degree (PhD or equivalent), extensive industry experience, leadership skills.Master's or PhD in relevant field, specialized nonclinical research experience.
Work EnvironmentLeadership in R&D departments, strategic planning, cross-functional collaboration.Laboratory setting, hands-on research, data analysis.

The Head Of Nonclinical Development focuses on strategic leadership and team management, while the Senior Nonclinical Scientist is primarily involved in executing research and data analysis. Both roles require advanced scientific credentials, but differ in scope and responsibilities within the nonclinical research hierarchy.

What are popular job titles related to Head Of Nonclinical Development jobs?

For Head Of Nonclinical Development jobs, the most frequently searched job titles are:

Executive Director, Clinical Pharmacology

Lexington, MA • On-site

Kiniksa Pharmaceuticals
Biotechnology Research and Development • 201 - 500 employees
Learn more about Kiniksa Pharmaceuticalsexternal

$89K - $122K/yr

Full-time

Re-posted 4 days ago

Job description

Kiniksa is seeking an experienced Executive Director of Clinical Pharmacology to provide strategic and scientific leadership in the analysis and interpretation of nonclinical and clinical pharmacokinetic (PK), pharmacodynamic (PD), and antidrug antibody (ADA) data across our portfolio. This role will play a critical part in informing dose selection, clinical trial design, and regulatory strategy for biologic therapies from pre-clinical development through IND and latestage development.

The successful candidate will work crossfunctionally with Nonclinical & Clinical Development, Translational Medicine, Biometrics, Regulatory Affairs, and CMC to ensure rigorous and integrated interpretation of PK and immunogenicity data to support clinical and regulatory decisionmaking.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week

Key Responsibilities (including, but not limited to):

  • Provide scientific leadership for clinical pharmacology strategy across programs, with emphasis on PK, ADA, and exposure-response relationships.
  • Lead the analysis, interpretation, and integration of PK and ADA data from rodent, nonhuman primate (NHP), and clinical studies.
  • Guide dose selection and optimization strategies using nonclinical-clinical translation and clinical PK/ADA data.
  • Interpret nonclinical PK and immunogenicity data to support first-in-human starting dose and escalation strategy
  • Serve as the clinical pharmacology subjectmatter expert on clinical study teams.
  • Support the design and interpretation of clinical PK/ADA sampling strategies, including timing and assay considerations and assess the impact of immunogenicity (ADA, NAb) on PK, efficacy, and safety across clinical studies.
  • Author and review clinical pharmacology-related sections of regulatory documents such as INDs, BLAs, Clinical study reports (CSRs), and Investigator's brochures

Standout Skills for Impact:

  • Proven track record supporting INDenabling through latestage clinical development and experience contributing to or leading regulatory submissions and agency interactions
  • Deep expertise in clinical and nonclinical PK, ADA and immunogenicity risk assessment, exposure-response interpretation
  • Strong understanding of biologic drug disposition, translational PK principles (rodent NHP human)
  • Excellent scientific writing and data communication skills
  • Demonstrated ability to influence program strategy through datadriven insights

Qualifications and Experience: 

  • PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or a related discipline (MD or PharmD with relevant experience will also be considered)
  • 12+ years of progressive experience with demonstrated program leadership. Strong handson experience with clinical and nonclinical PK data interpretation, Immunogenicity (ADA/NAb) assessment and impact analysis, Biologic drug development, ideally in cardiovascular, rare, and/or inflammatory diseases 
  • Strategic thinker with strong scientific judgment
  • Effective crossfunctional collaborator and communicator
  • Comfortable operating in a fastpaced, matrixed biotech environment
  • Ability to mentor, develop, and scientifically guide team members
  • High level of accountability, independence, and integrity
 

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