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Senior Director/VP – Translational Medicine & Pharmacology

🔥 15 hours ago
Translational MedicineTranslational PharmacologyBiomarker StrategyClinical Pharmacology
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📜 Description

  • Lead translational medicine and pharmacology strategy across the pipeline, initially focused on the Phase 3 vidofludimus calcium program in multiple sclerosis.
  • Design biomarker strategies for pharmacodynamics, efficacy, safety, and patient stratification, and integrate them into clinical trial protocols.
  • Partner with clinical, pharmacology, and biostatistics teams to translate preclinical findings into clinical dosing rationale and study design.
  • Lead mechanism-of-action work, PK/PD modeling, and exposure-response analyses for clinical and regulatory decisions.
  • Develop translational and pharmacology content for regulatory submissions and support FDA and EMA interactions.
  • Guide early-stage asset selection, scientific publications, external expert relationships, business development diligence, and development of the translational medicine function.

🛠️ Requirements

  • MD/PhD required; Minimum 12 years of translational medicine, clinical pharmacology, or related experience in the pharmaceutical or biotechnology industry
  • Demonstrated experience in neurology, immunology and/or autoimmune disease, ideally with a focus on multiple sclerosis
  • Proven track record of applying biomarker and translational strategies to advance programs through clinical development to regulatory submission
  • Deep understanding of PK/PD modeling, exposure-response analysis, and FDA/EMA regulatory expectations for translational data packages
  • Experience leading or supporting health authority interactions on translational and pharmacology topics
  • Strong cross-functional collaboration skills with the ability to influence without authority in a matrixed organization
  • Excellent written and verbal communication skills; experience presenting to executive leadership and scientific audiences
  • Comfort operating in a small-company environment with a high degree of autonomy and accountability; comfortable with ambiguity
  • Willingness to travel internationally, including periodic travel to Immunic's operations in Germany
Full job description

SUMMARY

We are seeking a Senior Director/Vice President of Translational Medicine and Pharmacology to serve as a scientific leader driving translational strategy across Immunic’s pipeline of selective, orally available immunology therapies. Reporting to the Chief Medical Officer, this role will play a critical part in advancing biomarker strategy, mechanism of action characterization, and translational pharmacology for the Phase 3 vidofludimus calcium program in multiple sclerosis, while shaping translational strategy for earlier-stage pipeline assets. You will bring deep translational science expertise, a track record of biomarker-driven clinical development, and the ability to operate effectively in a lean, cross-functional biotech environment.

RESPONSIBILITIES

  • Lead translational medicine and pharmacology strategy across Immunic's pipeline, initially with primary focus on the Phase 3 vidofludimus calcium program in relapsing and progressive multiple sclerosis

  • Design and oversee biomarker strategies, including pharmacodynamic, efficacy, safety, and patient stratification biomarkers, integrated into clinical trial protocols

  • Partner with Clinical Development, Clinical Pharmacology, and Biostatistics to translate preclinical pharmacology data into clinical dosing rationale and study design

  • Serve as the scientific lead for mechanism of action, PK/PD modeling, and exposure-response analyses supporting clinical and regulatory decision-making

  • Collaborate with Regulatory Affairs to develop translational and pharmacology sections of IND/CTA submissions, briefing documents, and BLA/NDA packages

  • Support and present at health authority meetings (e.g., FDA, EMA) on translational and pharmacology topics, responding to agency queries with scientific rigor and strategic clarity

  • Partner with Discovery and Preclinical teams to guide selection and advancement of early-stage pipeline assets based on translational rationale and mechanism of action

  • Partner with Medical Affairs and Clinical Development to drive the development and review of translational publications and conference presentations

  • Identify and develop relationships with MS experts, translational researchers, academic centers, and key opinion leaders in immunology and neurology

  • Contribute to business development activities by evaluating in-licensing opportunities and supporting scientific due diligence efforts

  • Help build and mentor a high-performing translational medicine function as the company evolves

QUALIFICATIONS & EXPERIENCE

  • MD/PhD required; Minimum 12 years of translational medicine, clinical pharmacology, or related experience in the pharmaceutical or biotechnology industry

  • Demonstrated experience in neurology, immunology and/or autoimmune disease, ideally with a focus on multiple sclerosis

  • Proven track record of applying biomarker and translational strategies to advance programs through clinical development to regulatory submission

  • Deep understanding of PK/PD modeling, exposure-response analysis, and FDA/EMA regulatory expectations for translational data packages

  • Experience leading or supporting health authority interactions on translational and pharmacology topics

  • Strong cross-functional collaboration skills with the ability to influence without authority in a matrixed organization

  • Excellent written and verbal communication skills; experience presenting to executive leadership and scientific audiences

  • Comfort operating in a small-company environment with a high degree of autonomy and accountability; comfortable with ambiguity

  • Willingness to travel internationally, including periodic travel to Immunic's operations in Germany

Immunic Therapeutics is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.

Please note, Immunic does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Immunic and the agency. Immunic will not pay any fees related to unsolicited resumes.

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