At Hemab you will join a clinical-stage biotech company on an exciting journey to build the ultimate clotting company focusing on high unmet need for patients suffering from neglected bleeding and thrombotic disorders. Based in Cambridge, US and Copenhagen, Denmark, Hemab will offer a great working environment, where we believe that a balanced and varied working life can go hand in hand with high quality drug discovery from idea to market.
As an Associate Director in Clinical Operations at Hemab, you will be responsible for the planning, implementation, conduct, and oversight of assigned studies or program. You will provide leadership as well as line management within Clinical Operations and guidance with regards to operational deliverables. You may lead complex studies and/or may be responsible for oversight across studies within a program
Key Responsibilities:
- Serve as the subject matter expert within clinical operations for the planning and execution of studies across all phases
- Work cross-functionally to ensure clinical program timelines and goals are met and risks are appropriately escalated
- Develop, review, and/or consult on clinical trial documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates
- Manage CRO study team(s), clinical sites, laboratory vendor(s), and other outsourced work on assigned studies to ensure consistency of methods, interpretation, and approach with other Hemab-sponsored studies
- Communicate regularly to stakeholders on program/trial status, tracking to goals, risks, and mitigations.
- Manage the clinical trial budget and provide financial reporting and projections as needed
- Operationalize and execute the Clinical Development Plan (CDP)
- Ensure trial adherence to ICH/GCP, federal and local regulations, and company specific SOPs
- Effectively evaluate qualified study sites, oversee monitoring activities, and support clinical site initiation visits, co-monitoring, and close-out visits as needed
- Assess study drug requirements and shipment and supply logistics, contributing to pharmacy manual
- Maintain tracking for study metrics that are essential to managing the study closely (patient visit information, data entry, monitoring, and data cleaning information, etc.)
- Oversee TMF filing and QC activities as needed
- Mentorship and line management of direct reports
Experience/Education
- Bachelor’s Degree in life sciences or healthcare discipline
- At least 9 years of clinical trial management experience and at least 2 years managing cross-functional project teams. Monitoring experience preferred
- Direct experience conducting early phase trials
- Experience in rare disease or orphan drug development preferred, with demonstrated understanding of unique challenges in patient recruitment, regulatory pathways, and engagement with specialized centers
- Working knowledge of ICH/GCP regulations and guidelines
- Solid understanding of cross-functional areas, including data management/biostatistics, regulatory affairs, and pharmacovigilance
- Proven verbal and written communication skills; enjoys interacting with others regularly
- Able to prioritize tasks and work independently
- Able to travel an average of 20-30%, both domestically and internationally
- Line management experience
Hemab is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
