As Senior Director, Clinical Research, you will have the opportunity to lead innovative clinical programs across our clotting disorder portfolio. You will provide clinical development leadership for cross-functional teams to support late phase clinical development activities including global regulatory filing for approval, support clinical study execution in a matrixed team environment, and shape the clinical development strategy.
- Serve as the clinical development lead for activities related to global regulatory engagements for several programs in partnership with clinical development team members and other line functions, including the preparation of regulatory documents and submissions.
- Lead and provide clinical and strategic guidance to study related documents including clinical study reports, BLA/MAA and other regulatory filing documents, study protocols and amendments, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other clinical development team members and line functions
- Provide clinical development leadership for cross-functional teams related to ongoing clinical stage programs in Von Willebrand Disease and rare bleeding disorders like Glanzmann Thrombasthenia, Factor VII deficiency, Bernard Soulier etc.
- Provide leadership and input to pipeline development strategy, including preclinical programs and external innovation/business development
- Present and communicate program related activities to senior company leadership
- Represent Hemab to external stakeholders, including investigators, key opinion leaders, governmental/policy groups, and community/patient advocacy groups,
- Support cross-function study teams for ongoing clinical trials including working with other team members to achieve efficient, high-quality study execution, data analysis, and study outputs, and serving as a back-up Medical Monitor as needed
What you'll bring:
- MD, MD/PhD, DO or the international equivalent
- Minimum of 4 years of pharmaceutical/Biotech industry experience in clinical development, including experience managing clinical trial programs and clinical development plans.
- Global clinical development experience including experience interacting with global regulatory authorities
- BLA/MAA filing experience is highly desired
- Clinical development and/or clinical/scientific experience in bleeding disorders preferred
- Ability to work collaboratively in a fast-paced, team-based matrix environment
- Ability to work independently and creatively to resolve challenges
- Excellent verbal and written communication skills
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.