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Director of Nonclinical Development Lead

2 months ago

Reston, Virginia, United States Proclinical Staffing Full time

Director of Nonclinical Development - Contract - Boston

Proclinical Staffing is seeking a seasoned professional to lead the Nonclinical Development function at a leading RNAi Therapeutics biotech with a rich pipeline of IND enabling programs.

Key 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. The successful candidate will contribute to our mission of delivering life-transforming medicines to patients using cutting-edge computation and AI.

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:

  • Developing and executing non-clinical study strategies to support clinical development.
  • Collaborating with cross-functional project teams to design and execute non-clinical development strategies.
  • Establishing and maintaining effective relationships with CROs and consultants for the design and execution of nonclinical studies.
  • Providing leadership for nonclinical project managers and ensuring all nonclinical programs are completed within established timelines.
  • Preparing and presenting nonclinical project updates to the Executive Team.
  • Collaborating closely with finance and operations teams.
  • Authoring, reviewing, and approving scientific reports that support regulatory documents.
  • Developing contingency plans and backup scenarios to proactively mitigate unforeseen circumstances.

Proclinical Staffing 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.