CSL Logo

CSL

Director, Nonclinical Due Diligence & External Innovation

Reposted 24 Days Ago
Be an Early Applicant
Remote
Hiring Remotely in USA
Expert/Leader
Remote
Hiring Remotely in USA
Expert/Leader
Lead and execute nonclinical due diligence for in-licensing, acquisitions, and collaborations. Integrate toxicology, PK/QSP, and pharmacology data to assess translational risks, identify FIH-enabling gaps, and propose mitigations. Produce DD reports and executive summaries, advise Business Development and Therapeutic Area teams, maintain DD frameworks, mentor junior staff, chair the NCD Review Committee, and escalate high‑impact issues to leadership.
The summary above was generated by AI

The Director Non-Clinical Due Diligence & External Evaluations provides scientific leadership for nonclinical due diligence supporting CSL’s in‑licensing, acquisitions, and strategic collaborations. The role ensures integrated, objective, and decision‑relevant evaluations of nonclinical pharmacology, PK/QSP, and toxicology data to identify development risks, data gaps, and mitigation strategies and to inform portfolio decisions.

The incumbent will further act as nonclinical representative for selected Research programs and support oversight of nonclinical strategies and programs across all Therapeutic Areas.

The role reports to the Executive Director, Head of Nonclinical Development.

Responsibilities and accountabilities

  • Leads operational execution of nonclinical due diligence for assigned opportunities.

  • Acts as hands‑on scientific integrator, translating expert input into clear risk narratives.

  • Trusted subject‑matter lead for nonclinical DD on individual deals.

  • Lead end-to-end nonclinical due diligence for individual assets or transactions, from request through final governance readout.

  • Integrate input from Toxicology, PK/QSP, Nonclinical Pharmacology, and external experts into a single, coherent scientific assessment.

  • Identify FIH‑enabling gaps, translational risks, and regulatory limitations, with clear mitigation proposals.

  • Prepare high‑quality DD reports, executive summaries, and risk tables for governance review.

  • Act as NCD scientific interface to Business Development and Therapeutic Area teams at the project level.

  • Contribute to maintenance and continuous improvement of nonclinical DD frameworks and templates.

  • Mentor junior contributors and matrix team members as appropriate.

  • Escalates complex or high‑impact issues to Head of NCD

  • Chair of “NCD Review Committee”

Qualifications:

Education:

  • Advanced degree (Ph.D., D.V.M., or equivalent) in toxicology, pharmacology, or a related field 

  • Toxicology training, board certification preferred

Experience :

  • Experience in nonclinical development (10+ years) with proven experience in due diligence or external innovation, ideally across various geographies.

  • Strong understanding of FIH‑enabling nonclinical requirements, particularly for biologics and complex modalities.

  • Ability to communicate complex scientific risk clearly to non‑expert stakeholders.

  • Experience across multiple therapeutic areas and modalities is highly desirable.

Competencies:

  • Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.

  • Experience in working in cross-functional, multicultural and international teams.

  • Excellent communication and analytical skills.

  • Experience in analyzing and presenting research results to scientific and professional audiences.

  • Strong planning and organizational skills.

  • Ability to work successfully in a matrix organizational structure.

  • Strong negotiation skills and ability to identify and engage internal and external expertise as needed.

  • Good understanding of drug development process, strong knowledge of ICH/GLP

  • Fluent in English, oral and written;

The role requires onsite presence 3 days per week.

The role can be based in Zurich, Switzerland or Waltham, USA.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

 

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.


You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

 

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Similar Jobs

2 Hours Ago
In-Office or Remote
Site of Old Bullion, NV, USA
177K-294K Annually
Senior level
177K-294K Annually
Senior level
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Build, test, and ship production-grade full-stack software and AI-powered systems for Pfizer’s Medical Affairs portfolio. Integrate LLMs, agentic AI, and RAG pipelines; develop scalable systems from prototypes through production; optimize prompts for cost, latency, and quality; integrate enterprise platforms; and monitor AI/ML performance. Collaborate with architecture, product, UX, and data engineering teams while maintaining strong code quality, documentation, testing, and verification practices.
Top Skills: Agentic AiAgileApi-First DesignAWSAzureCi/CdGdprGxpHipaaLlmopsLlmsMlopsRagSalesforce Life Sciences CloudSalesforce Marketing CloudScrumVector DatabasesVeeva Crm
15 Hours Ago
Remote or Hybrid
Entry level
Entry level
Cloud • Software
Build and operate AI-powered developer tools, agentic workflows, reusable skills, integrations, orchestration capabilities, backend services, and APIs. Integrate AI systems with source control, CI/CD, issue tracking, documentation, and developer environments. Apply testing, evaluation, monitoring, security, and feedback practices to non-deterministic AI systems while collaborating with developers and contributing to platform architecture and engineering processes.
Top Skills: Agentic AiAi Coding ToolsAPIsCi/CdContainersDistributed SystemsDocument DatabasesEmbeddingsGitGoJavaKotlinKubernetesLarge Language ModelsPythonRelational DatabasesRetrieval-Augmented GenerationTypescriptVector Databases
Yesterday
In-Office or Remote
USA
116K-193K Annually
Senior level
116K-193K Annually
Senior level
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Leads strategic feasibility analytics for global clinical trials, developing evidence-based country, site, enrollment, and protocol optimization strategies. Partners with cross-functional teams to assess recruitment assumptions, competitive intelligence, real-world data, site performance, and clinical trial technologies. Oversees feasibility outreach, site selection, scenario planning, portfolio intelligence, and KPI delivery while improving study startup and recruitment processes. Provides senior-level recommendations and influences stakeholders across Pfizer’s clinical development organization.
Top Skills: Decentralized Clinical Trial (Dct) TechnologiesProtocol SimulationsReal-World Data AnalyticsSite Predictability Engine

What you need to know about the Charlotte Tech Scene

Ranked among the hottest tech cities in 2024 by CompTIA, Charlotte is quickly cementing its place as a major U.S. tech hub. Home to more than 90,000 tech workers, the city’s ecosystem is primed for continued growth, fueled by billions in annual funding from heavyweights like Microsoft and RevTech Labs, which has created thousands of fintech jobs and made the city a go-to for tech pros looking for their next big opportunity.

Key Facts About Charlotte Tech

  • Number of Tech Workers: 90,859; 6.5% of overall workforce (2024 CompTIA survey)
  • Major Tech Employers: Lowe’s, Bank of America, TIAA, Microsoft, Honeywell
  • Key Industries: Fintech, artificial intelligence, cybersecurity, cloud computing, e-commerce
  • Funding Landscape: $3.1 billion in venture capital funding in 2024 (CED)
  • Notable Investors: Microsoft, Google, Falfurrias Management Partners, RevTech Labs Foundation
  • Research Centers and Universities: University of North Carolina at Charlotte, Northeastern University, North Carolina Research Campus

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account