Director of Nonclinical Development
2 weeks ago
Job Summary:
Proclinical Staffing is seeking a highly skilled and experienced professional to lead our Nonclinical Development team. As a key member of our organization, you will play a pivotal role in shaping our nonclinical strategy and overseeing the execution of non-clinical programs to advance our pipeline of innovative RNAi medicines.
Key Responsibilities:
- Develop and Execute Nonclinical Study Strategy: Oversee the design and execution of non-clinical study strategies, including experimental approaches, data packages, and regulatory content preparation.
- Deliver High-Quality Data Packages: Ensure the delivery of high-quality data packages to regulatory authorities to support clinical development.
- Collaborate with Cross-Functional Teams: Collaborate with cross-functional project teams to design and execute non-clinical development strategies.
- Establish Relationships with CROs: Establish and maintain effective relationships with Contract Research Organizations (CROs) and consultants for the design and execution of nonclinical studies.
- Lead Nonclinical Project Management: Lead nonclinical project managers and ensure all nonclinical programs are completed within established timelines.
- Present Nonclinical Project Updates: Prepare and present nonclinical project updates to the Executive Team.
- Collaborate with Finance and Operations Teams: Collaborate closely with finance and operations teams to ensure seamless execution of nonclinical programs.
- Author and Review Scientific Reports: Author, review, and approve scientific reports that support regulatory documents.
- Develop Contingency Plans: Develop contingency plans and backup scenarios to proactively mitigate unforeseen circumstances.
Requirements:
- PhD in Pharmacokinetics, Biology, Pharmacology, or a Related Discipline: Possess a PhD in pharmacokinetics, biology, pharmacology, or a related discipline.
- Deep Understanding of Drug Metabolism and ADME Concepts: Have a deep understanding of drug metabolism, ADME concepts, pharmacokinetics, and bioanalytical principles.
- Extensive Experience in Nonclinical Study Design and Execution: Possess extensive experience in nonclinical study design and execution leading to regulatory submissions.
- Strong Knowledge of Global Regulatory Requirements: Have strong knowledge of global regulatory requirements, with prior experience supporting regulatory submissions.
- Experience Working with Nonclinical CROs: Have experience working with nonclinical CROs to deliver fully costed agreements and study protocols.
- Commitment to Data Integrity: Demonstrate a commitment to generating data of the highest integrity, complying with regulatory requirements and ethical standards.
- Strong Project Management and Leadership Skills: Possess strong project management, organizational, and leadership skills.
- Excellent Communication Skills: Have excellent communication skills in verbal and written English.
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