Director Nonclinical Development Organon
Overview
Lead nonclinical subject matter expertise for Women’s Health General Medicines and Biosimilars programs. Reports to Executive Director and collaborates with clinical regulatory safety pharmacovigilance chemistry manufacturing and business development. Serves as nonclinical representative on asset development teams and supports regulatory submissions.
What You'll Do11
- 1Serve as nonclinical representative on asset development teams to support life-cycle management of products
- 2Author and review nonclinical CTD modules briefing books and other regulatory communications for global submissions
- 3Nonclinical point of contact for regulatory safety pharmacovigilance support
- 4Collaborate with CMC to assess impurities degradants and mitigate risks per regulatory requirements
- 5Provide scientific input in toxicology pharmacology DMPK for product development
- 6Prepare and review nonclinical documentation for regulatory submissions and interactions with health authorities
- 7Support global product regulatory activities including annual reporting literature and new applications
- 8Contribute to drug safety pharmacovigilance by reviewing literature for new risks and evaluating signals
- 9Collaborate with CMC and Occupational Safety to evaluate process impurities and conduct risk assessments
- 10Provide nonclinical support for occupational and environmental risk assessments
- 11Ensure compliance with GLP GCP and SOPs while supporting product portfolio according to standards
Requirements11
- 1PhD DVM or equivalent degree in pharmacology biology physiology biochemistry chemistry toxicology or related sciences
- 2Board certification in toxicology a plus such as DABT or ERT
- 3Minimum ten years of experience in pharmaceutical or biotech industry with deep knowledge of nonclinical disciplines
- 4Technical expertise in toxicology DMPK and regulatory guidelines for drug substance and product impurities
- 5Proven experience authoring and reviewing nonclinical sections of regulatory dossiers such as NDAs
- 6Demonstrated ability to lead cross functional projects especially global teams
- 7Strong leadership communication and collaboration skills with respect and integrity
- 8Excellent organizational abilities and ability to simplify complex scientific concepts
- 9Experience interacting directly with health authorities during regulatory submissions and interactions
- 10Familiarity with GxP requirements and recent changes in regulatory expectations
- 11Valid driving license and willingness to meet all travel credentialing requirements
Salary Insight
$152 - $259k per year
Location
Required Skills
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