Chief Medical Officer (CMO)

The Company

Our client is a Swedish clinical-stage biopharmaceutical company developing first-in-class treatments in one of the world’s largest unmet medical needs.

The company’s lead asset has successfully completed a randomized Phase II Proof-of-Concept clinical trial demonstrating statistically significant efficacy, excellent safety and tolerability, and clinically meaningful result.

The clinical results have recently been published in The Lancet Regional Health – Europe, providing strong external validation of the program.

The company is now preparing for Phase IIb development while actively pursuing strategic partnerships and international financing to maximize shareholder value.

About the role

Our client is seeking a strategic and business-oriented Chief Medical Officer, that will work closely with the CEO and the Board in shaping the development strategy including the clinical program and in driving the company’s overall value creation.

The CMO will take a central role in advancing the asset from a successfully completed Phase II Proof-of-Concept study into Phase IIb development and toward Phase III readiness.

The role entails overall medical and clinical responsibility, with a focus on driving clinical development forward while also contributing to the company’s long-term value creation.

A key responsibility for the CMO will be to translate feedback from the FDA and EMA Scientific Advice processes into an optimal Phase IIb program and ensure that the development strategy is fully aligned with regulatory requirements in both the US and Europe. In addition, the CMO is also highly involved in interactions with external experts, partners, and investors.

We are looking for someone who combines deep medical and clinical expertise with an entrepreneurial mindset and an understanding of how smaller development companies create value in preparation for future partnering.

Responsibilities and duties

The CMO is responsible for:

• Leading and developing the company’s medical and clinical R&D strategy
• Overseeing the design, execution, and follow-up of clinical studies
• Ensuring high medical quality and regulatory compliance
• Serving as the primary medical contact for CROs, Key Opinion Leaders, and regulatory authorities
• Lead the clinical and medical aspects of interactions with FDA and EMA, including Scientific Advice and alignment of the Phase IIb development strategy
• Contributing to the company’s overall strategy and value-creation activities, focusing on making the asset Phase III ready
• Supporting business development, partnering discussions, and due diligence processes
• Presenting the development strategy/data to investors, partners, and the board
• Ensuring the company builds a strong scientific and clinical position internationally
• Contributing to the development of publication strategy and scientific communication

Experience and background

We are seeking a senior medical expert with experience from innovative biotech or pharmaceutical companies.

Key requirements

• MD, PhD, or equivalent medical/scientific background
• Experience as CMO, Medical Director, or senior clinical development leader
• Documented experience in designing and leading a clinical development program from Phase II through to a pivotal/Phase III stage
• Experience interacting with regulatory authorities such as EMA and FDA
• Experience working closely with CROs and external research partners
• Strong understanding of clinical trial design, clinically meaningful endpoints, biomarkers, and regulatory development strategies
• Experience from smaller entrepreneurial biotech companies is highly meritorious
• Experience in investor relations, partnering, or due diligence is an advantage
• Previous involvement in licensing or exit processes is highly valuable

Personal qualities

We are looking for someone who combines scientific depth with business understanding and strong execution capability.

We believe you are

• Strategic and analytical
• Entrepreneurial and solution-oriented
• Communicative and educational
• Credible in dialogue with investors, researchers, and regulatory authorities
• Humble and accustomed to working operationally in smaller organizations, driven by being hands-on in all aspects to achieve strategic goals
• Driven with the ability to create momentum in complex projects
• Collaborative with a strong international mindset

Key success factors in the role

To succeed in this role, you need to be able to:

• Translate clinical data into clear business and investor value
• Build trust with regulatory authorities and external experts
• Ensure high quality and efficiency in clinical programs
• Contribute strategically to the company’s positioning toward future partnerships or exit
• Communicate complex science in a clear and compelling way

Education

MD, PhD or other research degree is preferred

Experience in psychiatry, CNS/neuroscience, or related therapeutic areas is an advantage

Other

Fluent English in both spoken and written form

Experience from international clinical environments

Ability to travel internationally when required

Welcome with Your Application!

For questions regarding the position, please contact recruitment consultant Daniel Kremer at +46 733 872724.

Please submit your application in the form of a CV and cover letter to daniel.kremer@moveup.se.

By submitting your application, you also consent to us storing your personal data, including your CV and cover letter, and acknowledge that we have the right to share this information with third parties (our client). You may withdraw your consent at any time.