Associate Director/Director, Nonclinical Development – Drive Innovation in Clotting Therapies for Hemab

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 neglected bleeding and thrombotic disorders. With offices in Boston, US, and Copenhagen, Denmark, Hemab cultivate a vibrant, agile and forward-thinking environment where innovation and high-quality drug discovery go hand in hand.

As an Associate Director/Director in Nonclinical Development, you will be at the forefront of planning, executing, and managing nonclinical safety/toxicology programs. You will be responsible for the required studies to enable rapid advancement through regulatory filings, working closely with an international team of talented colleagues and key external consultants across many functional disciplines. This is a unique opportunity to shape processes and contribute to groundbreaking work in toxicology as part of our newly formed Nonclinical Development team. Your role will be pivotal in developing and expanding the team's expertise, offering significant opportunities for personal and professional growth.

At Hemab, our culture is built on collaboration, innovation, and a commitment to making a difference in the lives of patients. We foster an environment where everyone can thrive both personally and professionally and we regularly celebrate our achievements and gather feedback to continuously improve our work environment.

What You’ll Do:

• Collaborate with program teams to execute integrated nonclinical safety strategies to support development projects 
• Drive the design of in vivo and in vitro studies to identify and mitigate test item-related toxicities across programs in Hemab
• Establish and manage strategic partnerships with CROs and provide oversight of outsourced studies
• Manage finalization of nonclinical study reports and other sub-vendor reports
• Prepare toxicological risk assessments to support drug development and manufacturing including potential excipient evaluations and PDE/OEL calculations
• Support regulatory submissions and interactions with various agencies
• Work independently and collaboratively in a fast-paced environment
  
  

Who You Are

Proven track record of accomplishments within nonclinical safety/toxicology within several of the following areas:

• A strategic thinker who seeks innovative ways to apply nonclinical safety in Hemab
• Deep knowledge in drug discovery and development including the progression of compounds through the discovery cycle into nonclinical and clinical development
• Highly organized and analytical with strong problem-solving skills
• Flexible team-player excited to collaborate with internal and external partners
• Knowhow of the regulatory processes and guideline compliance
• Theoretical and technical understanding of animal husbandry
• Strong focus on 3R and animal welfare
• Excellent planning skills combined with a strong scientific mindset
  
  

What You'll Bring

• Master’s degree within relevant field of expertise e.g. toxicology, veterinary medicine, pharmacology. PhD and other certifications are highly preferred
• 5+ years of experience in technical, scientific, and regulatory aspects of nonclinical safety/toxicology evaluation
• Experience in developing nonclinical safety/toxicology programs to support various modalities from early to late-stage drug development with a comprehensive understanding of the interplay between nonclinical safety, pharmacology, biomarkers, DMPK, clinical development, formulations and process change
• Experience interfacing with, and providing scientific guidance to CRO partners and proven ability to work efficiently in a hybrid model
• Ability to prepare relevant sections of regulatory filings such as INDs/CTAs and experience with global regulatory guidance documents (ICH /FDA) and Good Laboratory Practices (FDA and OECD)
• Proven success in supporting cross-functional project teams and ability to collaborate in a cross-functional matrixed organization