Director, Nonclinical Development

About the role

Primary Talent Partners has a new contract opening for a Director, Nonclinical Development to join a global health care company in Plymouth Meeting, PA. This is a 12-month contract to start with the potential for extensions. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship. ACA-compliant supplemental package available for enrollment.

Pay

$90.00 – $100.00/hr; W2 contract, no PTO, no benefits.

Responsibilities

• Serve as the Nonclinical representative on asset development teams (ADTs) in the development and execution of life-cycle management activities for products in the client’s portfolio.
• Author and review nonclinical CTD modules, briefing books, or other regulatory communications for regional regulatory submissions or renewals for global products within the client’s portfolio.
• Act as the nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance activities supporting the Women’s Health, General Medicines and Biosimilars product portfolio.
• Conduct nonclinical toxicology liaison with CMC and Occupational Safety to perform risk assessments and inform mitigation strategies in accordance with regional and/or global regulatory requirements.
• Collaborate with CMC to assess process manufacturing impurities, degradants, and/or extraneous matters and conduct risk assessments to inform mitigation strategies.

Tasks

• Provide scientific and nonclinical input (toxicology, pharmacology, DMPK) for products and ADTs.
• Prepare, contribute to, and/or review nonclinical or CMC documentation to support regulatory submissions to regional Health Authorities worldwide; may participate in interactions with Health Authorities.
• Support Regulatory activities for global products, including annual reporting of nonclinical activities and literature, support for new regional drug applications, regional license renewals, and authoring responses to questions from global Health Authorities.
• Support Drug Safety and Pharmacovigilance with activities such as review of nonclinical literature for new risks, signal evaluation for issues identified through pharmacovigilance or communications through Health Authorities, and authoring responses to regulatory inquiries as appropriate.
• Contribute to regional or global product label reviews and updates as appropriate.
• Collaborate with CMC and Occupational Safety to evaluate process manufacturing impurities and/or degradants and conduct risk assessments to inform mitigation strategies in accordance with regional and/or global regulatory requirements; provide nonclinical support for occupational and environmental risk assessments.
• Support the established product portfolio in line with Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs).

Qualifications

Education / Certificates

• Master’s, PhD, DVM or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences.
• Board certification in toxicology a plus (e.g., DABT, ERT).

Experience / Training

• A minimum of 10 years of experience in the pharmaceutical or biotech industry with extensive and in-depth knowledge across nonclinical disciplines in the context of drug development, including toxicology, DMPK and pharmacology.
• Demonstrated technical and scientific knowledge in nonclinical sciences with a particular emphasis on supporting late-stage drug development and life-cycle management.
• Demonstrated knowledge of nonclinical development as well as drug substance and drug product impurity-related regulatory guidelines and GxP requirements.
• Extensive experience with review and authoring nonclinical sections of regulatory dossiers (e.g., NDAs) and product labels with first-hand experience with agency interactions (meetings, briefing books and response documents).
• Experience working in project teams, preferably global project teams.

Skills

• Exemplifies leadership qualities including effective communication and collaboration, integrity, and respectful interactions with personnel.
• Excellent organizational and interpersonal skills.
• Ability to process and articulate complex ideas in a manner that can be clearly communicated to less technically trained individuals.
• Ability to prioritize and focus on important data and considerations to drive results and provide solution-oriented recommendations with an appropriate scientific rationale to address challenges associated with life-cycle management and CMC activities.

Schedule

40 hrs/week; Remote role.