Director, Medical Affairs, International - Zurich

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of tra ...

Jobbeschreibung

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

The Director, Medical Affairs is a key member of the International (ex-US) Medical Affairs team, responsible for driving medical strategy and execution for key MPS II programs across assigned markets. The role leads medical support for early access pathways, provides high-quality scientific support to healthcare professionals (HCPs), and acts as the primary medical point of contact for local patient organizations.

Key Accountabilities/Core Job Responsibilities:

1. Medical Strategy & Expertise

• Develop and execute the country/cluster medical plan for key MPS II programs in alignment with International and global strategies.

• Serve as the subject matter expert on the relevant disease area, treatment landscape, and key MPS II programs for internal and external stakeholders across selected ex-US markets.

• Provide high-quality medical input into brand plans, launch strategies, and life-cycle management activities for key MPS II programs.

•  Support internal training (e.g., medical, commercial, market access, patient advocacy teams) on the disease area and key MPS II program data. 

2. Early Access Pathways (EAPs) & Early Access Support

• Lead the medical oversight of early access pathways for key MPS II programs in assigned ex-US markets (e.g., early access programs), in close collaboration with Regulatory, Market Access, Pharmacovigilance, and Commercial.

• Provide medical review and input on early access protocols, eligibility criteria, and supporting documentation, ensuring scientific robustness and patient safety.

• Act as key point of contact for HCPs on key MPS II programs early access–related medical questions, case discussions, and appropriate use.

•  Ensure early access activities are conducted in line with local regulations, industry codes, pharmacovigilance requirements, and company SOPs in each relevant country/region.

• Monitor and summarise insights from early access use of key MPS II programs (where permissible) to inform broader medical and commercial strategy.

3. External Expert & HCP Engagement

• Build and maintain strong, ethical relationships with key opinion leaders (KOLs), specialists, and treatment centres involved in the care of patients eligible for key MPS II programs across assigned international markets.

•  Conduct and support scientific exchange through one-to-one meetings, advisory boards, medical education events, and congresses.

• Respond to unsolicited medical information requests regarding key MPS II programs and the disease area, providing balanced, evidence-based information in line with local regulations and company policy.

• Support teams, including commercial partners, with medical input for symposia, speaker programs, and other educational activities.

4. Patient Organisations & Advocacy

• Serve as the primary medical point of contact for local and regional patient organisations relevant to the key MPS II programs disease area, in collaboration with Patient Advocacy/Public Affairs.

• Provide scientific and disease education support to patient groups, ensuring communications are accurate, balanced, and non-promotional.

• Participate in joint initiatives (e.g., disease awareness, early diagnosis, care pathways) i n line with company policies and compliance requirements.

• Bring patient and caregiver perspectives into internal decision-making to help shape key MPS II programs strategy, services, and support materials  across ex-US markets.

5. Evidence Generation & Data Dissemination 

• Contribute to the design and implementation of local evidence generation activities related to key MPS II programs (e.g., RWE projects, registries, non-interventional studies), in alignment with global and international plans and within compliance frameworks.

• Interpret and communicate clinical and real-world data on key MPS II programs to internal and external stakeholders (e.g., presentations, publications, internal training).

• Provide medical input into key MPS II programs-related publications, abstracts, and posters, working with global and international teams.

6. Cross-Functional Collaboration & Complianc e

•  Partner closely with Regulatory Affairs, Market Access, Commercial, Patient Advocacy, Pharmacovigilance, and Legal/Compliance to ensure aligned and integrated planning for key MPS II programs across international markets. 

• Participate in review and approval of promotional and non-promotional materials related to key MPS II programs (as per local regulations and company procedures).

• Ensure all activities comply with relevant laws, regulations, industry codes (e.g., EFPIA and national codes where applicable), and internal SOPs.

• Contribute to forecasting, strategic planning, and budget discussions for key MPS II programs from a medical perspective.  

Qualifications & Experience

 Must-have:

• Advanced scientific/medical degree (MD, PharmD, PhD, or equivalent in life sciences). MD is preferred.

• Solid experience, at or near 10 years, in Medical Affairs within the pharmaceutical/biotech industry, ideally at an equivalent level.

• Proven experience in rare diseases, ideally aligned with the MPS II disease area (e.g., metabolic/genetic disorders).

• Demonstrated knowledge of early access pathways in ex-US markets (e.g., Europe and other international schemes) and their medical/regulatory implications.

• Strong track record of KOL engagement and external scientific communication.

• Fluency in German and/or Italian (spoken and written).

• Very good command of English (company working language).

Preferred:

• Fluency in German (spoken and written) strongly preferred; additional European or other international languages are an asset.

• Prior involvement with patient organisations and/or patient advocacy activities in rare diseases.

• Experience with real-world evidence projects, registries, or non-interventional studies.

• EU Citizenship and willingness to relocate to Switzerland. 

Competencies & Personal Attributes

• Strong strategic and analytical thinking; able to connect medical insights to business priorities while maintaining scientific integrity.

• Excellent communication and presentation skills, with the ability to tailor messages to HCPs, internal teams, and patient organisations.

• High level of integrity, ethics, and compliance mindset.

• Collaborative, solution-oriented, and able to work effectively in a matrix and multicultural environment.

• Comfortable with ambiguity, fast-changing environments, and rare disease complexity (small patient populations, limited data).

• Willingness and ability to travel regularly across assigned international markets (including overnight trips). 60% of the time. 

Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a pension, medical stipend, equity and a broad range of other benefits. 

Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.