Hemab Therapeutics · 1 day ago
Director/Senior Director of Clinical Research
Boston, MA
Full-time
Onsite
Lead/Staff, Director/Executive
5+ years expHemab Therapeutics is a clinical-stage biotech company focused on developing innovative treatments for rare bleeding and thrombotic disorders. The Director/Senior Director of Clinical Research will lead clinical development strategies and manage studies across Phase 1-3 programs, ensuring alignment with corporate objectives while collaborating with various teams.
BiotechnologyLife ScienceMedicalPharmaceutical
Responsibilities
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
Support regulatory submissions and documentation
Ensure adherence to GCP, ICH guidelines, and company policies
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
Communicate findings to internal and external stakeholders
May represent the organization at congresses and with patient advocacy groups
Qualification
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
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
Preferred
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
Ability to work effectively as part of a global organization
Location: Copenhagen or Boston is preferred
Company
Hemab Therapeutics
Hemab is a clinical-stage biotech company developing the first prophylactic therapeutics for serious, underserved bleeding and thrombotic disorders.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$347MKey Investors
Sofinnova PartnersAccess BiotechnologyNovo Holdings
2025-10-27Series C· $157M
2023-02-21Series B· $135M
2021-07-22Series A· $55M
Leadership Team
Benny Sørensen
Chief Executive Officer
Mads Behrndt
Chief Financial Officer
Recent News
2025-11-19
Company data provided by crunchbase