Join Hemab, a clinical-stage biotech company, on an exciting journey to build the ultimate clotting company. We focus on addressing the high unmet needs of patients suffering from rare bleeding and thrombotic disorders. With offices in Cambridge, MA, USA, and Copenhagen, Denmark, Hemab cultivates a vibrant, agile, and forward-thinking environment where collaboration, innovation, and high-quality biotherapeutics development go hand in hand.
Position Overview
We seek an experienced and motivated Director/Senior Director of Clinical Research to lead the clinical development of innovative treatment options for patients with underserved bleeding and thrombosis disorders. You will be responsible for developing and executing clinical development strategies and managing clinical studies across Phase 1-3 programs.
This role serves as a key member of the Clinical Research team, driving clinical strategy, overseeing study execution, and ensuring alignment with corporate objectives. The Director/Senior Director of Clinical Research will additionally liaise closely and frequently with Discovery teams to evaluate and implement translational development strategies.
The ideal candidate will be a strategic thinker who can navigate the complexities of the biotech environment while building strong relationships with key opinion leaders, and cross-functional teams.
Clinical Strategy & Execution
- Develop clinical development strategies, study designs, and protocols that meet scientific and regulatory objectives
- Oversee clinical trial documentation and study execution, including endpoint selection, medical monitoring, and clinical trial data review/interpretation
- Monitor program progress and develop contingency plans as needed
- In collaboration with Clinical Operations, responsible for oversight of study enrolment and timelines for key deliverables
- Collaborate with Discovery teams to identify and interrogate new drug candidates
Regulatory & Compliance
- Support regulatory submissions and documentation
- Ensure adherence to GCP, ICH guidelines, and company policies
Cross-Functional Collaboration
- Work closely with Clinical Operations, Clinical Science, Biostatistics, Regulatory Affairs, Medical Affairs, Quantitative Clinical Pharmacology and Safety/Pharmacovigilance teams to generate and deliver high-quality clinical data to support scientific and corporate objectives
- Partner with key opinion leaders and subject matter experts to support study design and strategic elements of the CDP
- Manage relationships with clinical study sites/investigators, CROs, vendors, and consultants
- Assess safety signals and participate in Safety Governance teams
Scientific Communication
Communicate findings to internal and external stakeholders
May represent the organization at congresses and with patient advocacy groups
Qualifications
Required
- Advanced degree (MD, PhD, PharmD) in life science or health science field
- 5+ years in clinical development within biotech/pharmaceutical industry or equivalent professional experience
- Proven track record executing Phase I-III clinical trials
- Strong understanding of regulatory environment and experience with regulatory interactions
- Extensive knowledge of GCP, clinical trial methodology, clinical processes, and regulatory requirements
Highly Desirable
- Experience in bleeding/thrombosis disorders, ultra-rare diseases, women with bleeding disorders
- Experience working in translational research groups, working to interrogate new targets and to select drug candidates
- Leadership of clinical strategy and content for regulatory submissions (BLA, MAA, IND, CTA)
- Team leadership and vendor management experience
- Pediatric clinical development experience
- Key Skills
- Demonstrated leadership with strong strategic and analytical thinking abilities
- Excellent communication and presentation skills
- Collaborative approach with ability to work across functions
- Strong organizational skills and ability to manage multiple priorities
- Comfortable in fast-paced biotech environment
- Experience with global, multi-center trials
Other:
- Travel: Up to 20%
- Ability to work effectively as part of a global organization
- Location: Copenhagen or Boston is preferred
