Blonde Inc.
Director/Senior Director of Clinical Research
Blonde Inc., Cambridge, Massachusetts, us, 02140
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.
Director/Senior Director of Clinical Research 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
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
Apply for the position
#J-18808-Ljbffr
Director/Senior Director of Clinical Research 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
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
Apply for the position
#J-18808-Ljbffr