Bioanalytical Principal Scientist

NMD Pharma is a clinical-stage biotechnology company dedicated to developing novel therapies to restore skeletal muscle health to enable better lives. Our lead development candidate, ignaseclant (formerly NMD670), is a first-in-class skeletal muscle-targeted therapy currently in clinical development across Charcot-Marie-Tooth disease (CMT), generalized myasthenia gravis (gMG), and spinal muscular atrophy (SMA).

NMD Pharma is at a pivotal moment in our journey, and we are expanding our team to support the next stage of clinical development and company growth. We are seeking a motivated and highly skilled Bioanalytical Principal Scientist to join us at this exciting stage in our development and contribute towards our mission of bringing life-changing therapies to patients living with neuromuscular diseases.

Your role

You provide scientific and strategic bioanalytical support from early research through non-clinical and clinical studies. You integrate exploratory and regulated bioanalysis, ensuring robust method development, validation, and delivery of high-quality data with scientific rigor and full regulatory compliance. You will also be supporting translational research and clinical development by biomarker validation and sample analysis.

As bioanalysis and biomarker analysis activities are primarily outsourced, the position requires strong oversight of external providers, including scientific guidance and performance management. Close cross-functional collaboration is essential to ensure alignment with program strategies and timelines.

The role carries significant scientific ownership and provides the opportunity to influence development decisions across multiple programs.

Your Responsibilities

• Define and execute the bioanalytical strategies from late discovery through IND and into early clinical development, ensuring alignment with overall program objectives.
• Provide scientific leadership and strategic direction for bioanalytical activities across research, non-clinical, and clinical phases.
• Lead assay strategy, including selection, development, validation, transfer, and lifecycle management in both exploratory and regulatory settings.
• Oversee outsourced bioanalysis and biomarker activities, ensuring high-quality, timely, and compliant data delivery from external partners.
• Serve as the primary scientific interface with CROs and laboratories, including protocol review, data interpretation, troubleshooting, and performance oversight.
• Drive biomarker analysis to enable translational insights, demonstrate proof-of-mechanism, and inform clinical development decisions.
• Ensure compliance with applicable regulatory requirements (e.g., GLP, GCP, FDA/EMA bioanalytical guidelines) and maintain inspection readiness.
• Contribute to study reports, regulatory submissions, IND-enabling documentation, and briefing packages.
• Collaborate cross-functionally with Research, Non-Clinical, Clinical, Regulatory, and CMC and Project Management to ensure strategic alignment and seamless phase transitions.
• Proactively identify scientific and operational risks, implement mitigation strategies, and ensure continuity from exploratory to fully regulated bioanalysis

Your Profile

• PhD or MSc in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related life science discipline.
• Significant industry experience in bioanalysis within pharmaceutical or biotechnology drug development.
• Demonstrated experience supporting bioanalytical strategies across research, non-clinical, and clinical development stages.
• Strong knowledge of global regulatory requirements and guidance for bioanalysis (e.g., GLP, GCP, FDA and EMA bioanalytical guidelines).
• Proven track record of in overseeing outsourced bioanalytical and biomarker activities, including CRO selection, scientific oversight, data review, and issue resolution.
• Hands-on experience with bioanalytical method development, validation, transfer, and lifecycle management (e.g., LC-MS/MS, ligand-binding assays, or other relevant platforms).
• Experience contributing to regulatory documentation and submissions (e.g., IND/CTA packages, study reports, briefing documents).
• Solid understanding of biomarker analysis and strategies and their application in translational research and clinical development.
• Strong cross-functional collaboration skills with the ability to operate effectively in a matrix organization.
• Self-driven, with a high degree of ownership, and the ability to independently lead activities in a dynamic environment.
• Professional fluency in English (written and spoken)

What we offer/Benefits

We offer a competitive package and opportunities for professional development in a collaborative and innovative work environment.

You will join a focused biotech organisation where scientific rigor is highly valued and where your contributions will directly influence non-clinical and clinical development. As we advance our clinical programs, you will be part of a dynamic environment that demands precision, clarity, and adaptability.

Equal Opportunities

NMD Pharma takes its stance on DEI seriously and welcomes diverse candidates: The company is committed to providing equal opportunities for all candidates regardless of, for example (and not limited to), gender, ethnicity, and neurodivergence.

How to apply

Please submit your CV and cover letter via our recruitment portal. Applications will be reviewed on an ongoing basis and we encourage you to share your application today not to miss out on this opportunity. For questions regarding the position please reach out to Maja Nielsen, People & Culture at mbn@nmdpharma.com

Iinformation about NMD Pharma is available at our website www.nmdpharma.com and on our LinkedIn page https://www.linkedin.com/company/nmdpharma/

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