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 Boston, 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.
The Director / Senior Director of Bioanalytics and DMPK plays a key role leading bioanalytic efforts for innovative programs at Hemab. In this role you will develop and implement bioanalytical strategies and provide critical basic research and development support for products in Research and Development. Additionally, you will provide guidance and scientific stewardship for all preclinical candidates and will continue building a high-performing expertise function that will provide PK and biomarker assay support for the non-clinical and clinical development of Hemab’s blood clotting therapy programs.
As a Director of DMPK and Bioanalytics, you will work closely with our research and preclinical team. Therefore, you must be highly adept at building and managing relationships across various functions, and positioning results with a deep scientific understanding as to how the findings relate to early lead selection through development.
ESSENTIAL DUTIES AND RESPONSIBILITIES TO PERFORM THIS JOB SUCCESSFULLY INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING:
- Responsible for development and validation of highly sensitive and specific bioanalytical methods for quantitative analysis of candidate molecules, metabolites, and biomarkers, to support a diverse portfolio of candidate molecule in non-clinical and clinical studies.
- In collaboration with project teams and CROs, engage in the design, execution, analysis, interpretation, and communication of all non-clinical and translational DMPK work packages to support projects in lead optimization, clinical candidate selection and development
- Technical monitoring during bioanalytical method development, validation, and sample analysis; overseeing data/method transfer between CROs
- Author, review and interpret bioanalytic data and reports
- Determine additional bioanalytical requirements if needed and perform regular site visits and inspections
- Responsible for high quality reports for regulatory submissions (such as INDs or Common Technical Documents) as well as for implementation of a strong quality and compliance program for all bioanalytical work, including compliance with GxP regulations for non-clinical safety and clinical studies
- Drive continuous innovation and change internally and externally and closely collaborate internally with Research groups, Safety Assessment, Translational Medicine, Regulatory Affairs, Clinical Development and Clinical Operations groups to align on strategy and tactics
To perform this job successfully, you must be able to perform each essential duty satisfactorily. However, in case of disabilities reasonable accommodations may be made. The requirements listed below are representative of the knowledge, skill, and/or ability required, or which are expected to be developed in due course.
- Proven track record of research accomplishments
- Excellent managerial and leadership skills. Must be highly organized and extremely analytical with strong problem-solving skills
- Deep knowledge in drug discovery and development including the progression of compounds through the discovery cycle into non-clinical and clinical development
- Flexible team-player excited to collaborate with internal and external partners
EDUCATION AND/OR EXPERIENCE
- Ph.D. in pharmacokinetics, drug metabolism, biochemistry, or equivalent
- Minimum of 10 years' industry experience with bioanalysis, pharmacokinetics and pharmacodynamics related to non-clinical development. This experience should come within a biotechnology and/or pharmaceutical environment and inside a complex research and development setting
- Extensive experience with assay development, optimization, qualification and validation including transfer to CROs as part of the process. Track record of independently authoring and providing regulatory guidance to team members on technical reports/ summaries, suitable for inclusion in registration dossiers (IB, IND/IMPD, NDA/BLA) and managing correspondence with regulatory authorities.
- In-depth knowledge of GLP/GCP regulations
- Track record in innovation and creativity, critical scientific thinking and analysis, with a deep level of curiosity and understanding of new technologies and cutting-edge approaches to address DMPK challenges
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.
As a healthcare company, Hemab has an important responsibility to protect individual and public health. All roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.