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Company

Certara · 1 day ago

Senior Director - Toxicology, CDDS

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

8+ years exp

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BiotechnologyHealth Care

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Responsibilities

Contribute to due diligence and gap analysis of nonclinical data packages.

Design programs to support INDs, NDA/BLAs and post-registration studies.

Outline studies and in partnership with clients, identify CROs to run these studies; manage the data/information analysis with our client to draft reports and finalize with client.

Prepare content of regulatory documents for filing.

Design investigative programs to address toxicology findings/issues/circumstances to determine human relevance.

Represent client to regulatory authorities (as needed/requested).

Advise clients on prioritization of their portfolio.

Serve on cross-functional drug development teams as toxicology lead.

Provide toxicology overview of full portfolio with potential investors to assist clients in obtaining funding.

May manage a limited number of direct reports.

Influencing the disciplines of pharmacology and toxicology in the context of drug development.

Qualification

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PharmacologyDrug Development ExperienceRegulatory Agency InteractionRegulatory Submission AuthoringCross-Functional Team LeadershipBoard CertificationTK/PK Data AnalysisGLPNon-GLP StudiesTherapeutic Area KnowledgeSafety Margin GenerationClient ManagementProject ManagementMicrosoft WordMicrosoft PowerPoint

Required

PhD in quantitative Pharmacology or Toxicology, or related field.

At least 8-10 years post doctorate experience in a drug development company, CRO, consulting organization, or FDA (R&D, nonclinical drug development).

Experience in the design and outsourcing of GLP and non-GLP toxicology and safety pharmacology studies.

Drug development experience across multiple therapeutic areas, such as oncology, CNS, inflammation, autoimmunity, metabolic disease, or cardiovascular, with small molecules and biologics.

Experienced in the generation of safety margins based on nonclinical toxicity findings and target clinical exposure data.

Experience authoring the relevant nonclinical sections of IND’s, NDA/BLA’s, and other regulatory submission documents (SPA, pre-IND/Type B/Type C meeting briefing documents etc.

Ability to lead and work in cross functional project teams.

Demonstrated experience leading and managing projects.

Has served as a leader on teams and strongly demonstrated ability to work and excel in team collaboration.

Excellent written, verbal, and inter-personal communication skills.

Possess a strong focus on influencing at high levels, innovation, and customer centricity.

Strong initiative, self-motivation, and coordination with other team members.

Strong client and alliance management skills.

Ability to work across functions to implement company initiatives.

Proficient in Microsoft Word and Power Point.