Senior Nonclinical Development Lead

6 days ago

London, Greater London, United Kingdom Proclinical Staffing Full time
Lead Nonclinical Development at Proclinical Staffing

We are 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:

  1. Develop and execute nonclinical study strategies, designs, and protocols to support clinical development.
  2. Collaborate with cross-functional project teams to design and execute non-clinical development strategies.
  3. Establish and maintain effective relationships with CROs and consultants to ensure high-quality nonclinical studies.
  4. Lead nonclinical project managers to ensure timely completion of nonclinical programs.
  5. Prepare and present nonclinical project updates to the Executive Team.
  6. Collaborate closely with finance and operations teams to ensure seamless project execution.
  7. Author, review, and approve scientific reports that support regulatory documents.

Requirements:

  1. PhD in pharmacokinetics, biology, pharmacology, or a related discipline.
  2. Deep understanding of drug metabolism, ADME concepts, pharmacokinetics, and bioanalytical principles.
  3. Extensive experience in nonclinical study design and execution leading to regulatory submissions.
  4. Strong knowledge of global regulatory requirements, with prior experience supporting regulatory submissions.
  5. Experience working with nonclinical CROs to deliver fully costed agreements and study protocols.
  6. Commitment to generating data of the highest integrity, complying with regulatory requirements and ethical standards.
  7. Strong project management, organizational, and leadership skills.
  8. Excellent communication skills in verbal and written English.

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