Director of Nonclinical Development - Contract - Boston, MA
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
