Director of Nonclinical Development

Director of Nonclinical Development - Contract - Boston, MAProclinical is seeking a dynamic and innovative individual to lead the Nonclinical Development function at a leading RNAi Therapeutics biotech with a rich pipeline of IND enabling programs.Primary Responsibilities:This role is pivotal in driving nonclinical strategy and overseeing the execution of non-clinical programs to advance our pipeline of innovative RNAi medicines. This is an exciting opportunity to contribute to our mission of delivering life-transforming medicines to patients using cutting-edge computation and AI. Skills & Requirements:A PhD in pharmacokinetics, biology, pharmacology or a related discipline.Extensive experience in nonclinical study design and execution leading to regulatory submissions.Strong knowledge of global regulatory requirements, including FDA, EMA, MHRA, and other major regulatory authorities.Knowledge of the CRO landscape and experience working with nonclinical CROs.A commitment to generating data of the highest integrity, complying with regulatory requirements and ethical standards.Excellent project management, organizational and leadership skills.A background in therapeutic siRNA or other oligonucleotide therapeutics. The Director of Nonclinical Development's responsibilities will be:Oversee non-clinical study strategy, design, and execution for the pipeline.Deliver high-quality data packages to regulatory authorities, supporting clinical development.Collaborate with cross-functional project teams for design and execution of non-clinical development strategy.Establish and maintain effective relationships with CROs and consultants for the design and execution of nonclinical studies.Provide leadership for nonclinical project manager and ensure all nonclinical programs are completed within established timelines.Prepare and present nonclinical project updates to the Executive Team.Collaborate closely with finance and operations teams.Author, review and approve scientific reports that support regulatory documents.Develop contingency plans and backup scenarios to proactively mitigate unforeseen circumstances. If you are having difficulty in applying or if you have any questions, please contact Max Robinson at Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.Proclinical Staffing is an equal opportunity DSCIC

Created: 2024-10-22