On-Board Services is hiring a Remote Director of Nonclinical DevelopmentFor immediate consideration please send your resume to Subject Line: Position Title and State you are located 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: 1st
Benefits: 401K, Dental insurance, Life Insurance, Medical Insurance, Vision Insurance, PTO
Compensation: $100/HR
Position OverviewWe 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.
Position Details - Schedule: 40 hours per week
- Duration: 12-month contract
- Location: Remote
QualificationsEducation / 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.
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