Part-Time Director of Nonclinical Development

Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America. We are seeking a Director, Nonclinical Development to provide nonclinical subject matter expertise supporting products across Women’s Health, General Medicines, and Biosimilars.

 
About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.
 
Position Details:
Title: Director of Nonclinical Development
Position Type: 1 year contract with additional opportunity contingent upon performance and continued business need
Job Location: Remote
Shift:1^{st - part-time, 20 hours per week} 
Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance, PTO 
Compensation: $100/HR
 
Position Overview
We are seeking a Director, Nonclinical Development to provide nonclinical subject matter expertise supporting products across Women’s Health, General Medicines, and Biosimilars. This role will collaborate closely with cross-functional teams including Clinical Development, Regulatory Affairs, Safety and Pharmacovigilance, Chemistry, Manufacturing and Controls (CMC), Medical Affairs, and Business Development.
The Director will serve as the nonclinical representative on asset development teams and support the lifecycle management of products. This position will also contribute to and review nonclinical content for regulatory submissions, renewals, and other regulatory communications, as well as support toxicological risk assessments related to CMC activities.

Responsibilities

• Serve as the Nonclinical representative on asset development teams (ADTs), supporting the development and execution of product lifecycle management activities.
• Provide scientific and nonclinical expertise in toxicology, pharmacology, and DMPK.
• Author, contribute to, and review nonclinical sections of regulatory submissions, including CTD modules, briefing books, investigator brochures, and other regulatory documents.
• Support regional and global regulatory submissions, license renewals, annual reporting, and responses to questions from Health Authorities.
• Participate in interactions with Health Authorities, including meetings, briefing books, and response documents.
• Serve as a nonclinical point of contact for Regulatory Affairs, Safety, and Pharmacovigilance activities.
• Support Drug Safety and Pharmacovigilance through review of nonclinical literature, evaluation of emerging risks and safety signals, and preparation of responses to regulatory inquiries.
• Contribute to regional and global product label reviews and updates.
• Collaborate with CMC and Occupational Safety to evaluate manufacturing impurities, degradants, and other materials and conduct toxicological risk assessments.
• Provide nonclinical support for occupational and environmental risk assessments and develop scientifically sound mitigation strategies.
• Ensure activities supporting the established product portfolio align with GLP, GCP, applicable regulatory requirements, and standard operating procedures.
• Work effectively within global, cross-functional project teams and provide solution-oriented recommendations supported by appropriate scientific rationale.

Qualifications
Education / Certifications

• Master’s, PhD, DVM, or equivalent advanced degree in Pharmacology, Biology, Physiology, Biochemistry, Chemistry, Toxicology, or a related scientific discipline.
• Board certification in Toxicology is a plus (e.g., DABT, ERT).

Required Experience

• 10+ years of experience in the pharmaceutical or biotechnology industry with extensive knowledge across nonclinical disciplines, including toxicology, DMPK, and pharmacology.
• Strong technical and scientific knowledge of nonclinical development, particularly in support of late-stage drug development and lifecycle management.
• Knowledge of nonclinical development, drug substance and drug product impurities, regulatory guidelines, and GxP requirements.
• Extensive experience authoring and reviewing nonclinical sections of regulatory dossiers, including NDAs and other regulatory submissions.
• Hands-on experience supporting Health Authority interactions, including meetings, briefing books, and response documents.
• Experience working within cross-functional, preferably global, project teams.

Skills

• Strong leadership, communication, collaboration, and interpersonal skills.
• High level of integrity and professionalism with the ability to work effectively across diverse teams.
• Excellent organizational skills and ability to manage multiple priorities.
• Ability to translate complex scientific concepts into clear, concise information for both technical and non-technical audiences.
• Strong analytical and problem-solving abilities with a focus on prioritizing key data and considerations.
• Ability to develop solution-oriented recommendations supported by sound scientific rationale, particularly in support of lifecycle management and CMC activities.

 
 
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.

The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC.  On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.”

On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
 
JD# 25-01345
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