Head of Non-Clinical

A vital role in a commercial-stage biotech company that develops novel treatment paradigms within immunology and inflammation.

As Head of Non-Clinical at MC2 Therapeutics, you will enter an exciting and newly established position with direct report to the COO.

In this position, you will have a significant impact and act as the go-to non-clinical profile at MC2 Therapeutics, where you will be responsible for program set-up, oversight, and reporting for new nonclinical programs and coordinating non-clinical activities with CROs.

Main tasks include (but are not limited to):

• Overall scientific management of non-clinical activities and studies.
• Drive strategies and activities such as molecular target assays, PK/PD models, and biomarker studies.
• Manage and oversee external toxicology and ADME studies with CROs and relevant expert consultants.
• Act as a scientific expert and lead interactions with external and international stakeholders (e.g. regulatory authorities, non-clinical experts/consultants, academic groups, CROs) and internal stakeholders (e.g. research, safety, regulatory, clinical development, and CMC).
• Contribute to the overall scientific strategy and product pipeline and give in-depth scientific advice on potential new projects (internal and external).
• Generating and ensuring the quality of non-clinical parts of key documents (e.g. Investigators’ brochure, non-clinical protocols, study reports, non-clinical components of regulatory submissions).
• Potentially support of clinical activities, e.g. bioanalytical development and biomarker evaluation.
• Set the agenda for high-quality scientific non-clinical publication plans and patent opportunities.

To thrive in this position, you have at least 5-10 years of experience in non-clinical expert roles in drug development in the pharma/biotech industry, where you have obtained excellent strategic, operational, and practical competencies to keep a good overview of activities as well as being hands-on through the whole process. Experience in skin biology is an advantage.

You have a broad technical profile and may have specialised in Pharmacokinetics, toxicology, or metabolism. ADME and in vivo experience is expected, and it is a plus if you have experience with CRO collaboration.

We believe you have a university degree (preferably a Ph.D.) in biochemistry/biology, veterinary sciences, pharmacology, medicine, or an equivalent field.

As a person, you are self-driven, able to take responsibility for your projects, and have a natural interest in directly engaging in quality-related matters. You have strong collaborative skills and can create successful working relationships with internal and external stakeholders.

MC2 Therapeutics offers an exciting and challenging position in an entrepreneurial and international company with a short line of command. The candidate will be involved in activities that are central to MC2 Therapeutics’ strategy and work with highly skilled and experienced colleagues to advance the exciting product pipeline.

Travelling: 5-15 days/year.

Domicile: MC2 Therapeutics’ headquarter in Hørsholm, north of Copenhagen.

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital, via e-mail: [email protected], or Senior Research Consultant Caroline Krüger, Unique Human Capital, on E: [email protected]. All applications must be in English and are treated confidentially.

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MC2 Therapeutics
MC2 Therapeutics is a commercial biotech company developing novel treatment paradigms for immunology and inflammation (“I&I”) diseases for which there are no or minimal approved treatment options).

By combining cross-silo thinking and deep knowledge of immunology with a multidisciplinary approach spanning all fields of science and product development, MC2 Therapeutics has an enhanced ability to identify truly differentiated new treatment opportunities and advance them through clinical development for patients globally.

Read more at www.mc2therapeutics.com

Adresse: Hørsholm, north of Copenhagen