Updated October 2026 – see editor’s note below.

Margrethe Sørgaard has over 25 years of experience in clinical development, clinical operations, medical affairs, and drug safety/pharmacovigilance (PhV). Her background includes global responsibilities at Scandinavian biotech companies, for example BioInvent International and Circio Holding, where she navigated products through clinical development towards market while engaging with regulatory agencies such as the FDA and EMA, she describes.

“My deep understanding of Good Clinical Practice (GCP) and PhV is reinforced by my experience serving as an EU Qualified Person for Pharmacovigilance (QPPV) in biotech and working as a GCP/PhV inspector for the Norwegian Medicines Agency (NOMA), including participation in the EMA’s GCP and PhV inspectors working groups. At NOMA, I later led the Safety Assessment unit that is responsible for the pre- and post-marketing assessment of safety documentation from the pharmaceutical industry. Establishing quality systems for clinical development and safety to ensure regulatory compliance has been a significant part of my journey, alongside developing substantial audit and inspection experience,” she explains.

“In addition to my technical knowledge, leading and managing teams has been a core aspect of my career, with active participation in leadership groups within both biotech companies and NOMA,” she adds. 

A unique opportunity

Sørgaard is now Senior Vice President (SVP) of Clinical Operations and Pharmacovigilance at Calluna Pharma, a clinical-stage Norwegian company that develops therapies designed to defeat chronic inflammation and fibrosis at the source.

“The company’s focus on precision targeting of upstream innate immune amplifiers stands out as a groundbreaking strategy. By disrupting a wide range of disease-associated downstream signaling pathways, while maintaining a favorable safety profile, Calluna’s therapies hold great promise,” says Sørgaard. “The clinical-stage lead program, CAL101, is a monoclonal antibody that neutralizes the bioactivity of S100A4, a DAMP protein implicated in serious and life-threatening fibro-inflammatory diseases. Another program of particular interest is CAL102, a monoclonal antibody that neutralizes oxidized phospholipids, which play a significant role in the onset and progression of a wide range of acute and chronic inflammatory and fibrotic diseases. CAL102 has demonstrated efficacy in several preclinical disease models.”

In the role, she is particularly eager to apply her expertise to build and lead a team towards establishing and refining the necessary procedures and processes to help develop Calluna’s clinical programs, she says. “Additionally, ensuring that our programs are cost-effective and have the highest probability of success for both the company and future patients is a central goal,” she adds.

This role offers a unique opportunity to leverage my past experience while contributing to pioneering treatments that hold great potential for addressing unmet medical needs.

“Overall, as part of the leadership team, I’m also looking forward to collaborating closely to ensure that we take our antibodies from preclinical stages through to clinical proof-of-concept (PoC), not least our lead product, CAL101, as it progresses into Phase 2a clinical development in fibro-inflammatory indications. This role offers a unique opportunity to leverage my past experience while contributing to pioneering treatments that hold great potential for addressing unmet medical needs,” says Sørgaard.

Passion, curiosity, and resilience

Throughout her career Sørgaard has held several different leadership roles, and I ask about her advice to other women who want to have these kinds of roles, and if she has any thoughts on how we can get more women into these positions.

“My advice to women aspiring to hold leadership roles in life sciences is rooted in passion, curiosity, and resilience. Firstly, find your passion and stay curious. It’s essential to immerse yourself in what truly excites you and continually seek knowledge. The life sciences field and STEM [science, technology, engineering, and mathematics] in general is constantly evolving, and a commitment to lifelong learning will keep you at the forefront of your industry,” she says.

Trust your instincts and don’t overthink your decisions. Often, your initial gut feeling is a powerful guide. Coupled with your expertise, it will help you navigate complex situations with confidence.

“Push yourself to learn as much as possible, and don’t be afraid to challenge existing norms. Leadership often involves questioning established practices and innovating beyond conventional boundaries. Embrace this mindset and use it as a driving force in your career. Don’t be afraid to speak up and share your opinions. Your voice is valuable and contributes to the diversity of thought necessary for effective leadership. Speaking up not only advances your ideas but also sets an example for others to follow. Don’t let the fear of failure deter you. Instead, view it as an opportunity to learn and grow. Trust your instincts and don’t overthink your decisions. Often, your initial gut feeling is a powerful guide. Coupled with your expertise, it will help you navigate complex situations with confidence.”

Finally, be yourself, emphasizes Sørgaard. “Authenticity is a key ingredient in successful leadership. Embrace your unique perspective and strengths and let them shine in your role. By being true to yourself, you’ll inspire others and foster a more inclusive and dynamic work environment.” 

When it comes to encouraging more women to take on leadership roles, it’s crucial to create supportive networks and mentorship opportunities, she adds. “Promoting these principles and providing role models who embody them will help pave the way for future leaders in life sciences,” concludes Sørgaard.

Editor’s note: This interview was first published in October 2024. Margrethe Sørgaard continues as Senior Vice President of Clinical Operations and Pharmacovigilance at Calluna Pharma. In October 2026, Calluna completed dosing in its global Phase 2 AURORA study of CAL101 in idiopathic pulmonary fibrosis, which enrolled 161 patients. Topline results are expected in the first quarter of 2027.