Director of Nonclinical Development

Highly Competitive
  1. Permanent
  2. Senior/Director & VP
  3. United States
Boston, USA
Posting date: 06 Sep 2024
62174

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Director of Nonclinical Development - Contract - Boston

Proclinical 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 m.robinson@proclinical.com

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 employer.

INDSCIC

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