Blonde Inc.
Senior Director/Director in Nonclinical Development
Blonde Inc., Boston, Massachusetts, us, 02298
Senior Director/Director in Nonclinical Development
Join Hemab, a clinical‑stage biotech company, on an exciting journey to build the ultimate clotting company. We are dedicated to addressing the high unmet needs of patients suffering from neglected bleeding and thrombotic disorders. With offices in Boston, US, and Copenhagen, Denmark, Hemab is a truly international and collaborative, forward‑thinking where innovation and high‑quality drug discovery go hand in hand.
As a Senior 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.
This role offers a unique opportunity to influence processes, build capacity and grow professionally in a company where scientific impact and personal development are equally valued.
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. We place great emphasis on teamwork and value individuals who excel as team players. We believe that collaboration across disciplines is essential for driving innovation and achieving our shared goals. As part of our Nonclinical Development team, your ability to work effectively with colleagues and contribute to a supportive, collegial environment will be highly regarded. We regularly celebrate our achievements and gather feedback to continuously improve our work environment.
What You’ll Do
Collaborate with program teams to design and 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
Be a core/asset team member and be responsible for the nonclinical subteam in development projects
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 You are a collaborative and strategic leader with a strong scientific foundation and a pragmatic mindset. You thrive in an international setting, value teamwork and have a 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 and project management skills
What You Bring
Master’s degree within relevant field of expertise e.g. toxicology, veterinary medicine, pharmacology. PhD and other certifications are highly preferred
10+ 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
Why Join Hemab
Make a meaningful difference for patients with serious and underserved conditions
Work in a collaborative, trust‑based culture with a strong scientific focus and team spirit
Be part of a growing international biotech with high ambitions
#J-18808-Ljbffr
As a Senior 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.
This role offers a unique opportunity to influence processes, build capacity and grow professionally in a company where scientific impact and personal development are equally valued.
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. We place great emphasis on teamwork and value individuals who excel as team players. We believe that collaboration across disciplines is essential for driving innovation and achieving our shared goals. As part of our Nonclinical Development team, your ability to work effectively with colleagues and contribute to a supportive, collegial environment will be highly regarded. We regularly celebrate our achievements and gather feedback to continuously improve our work environment.
What You’ll Do
Collaborate with program teams to design and 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
Be a core/asset team member and be responsible for the nonclinical subteam in development projects
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 You are a collaborative and strategic leader with a strong scientific foundation and a pragmatic mindset. You thrive in an international setting, value teamwork and have a 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 and project management skills
What You Bring
Master’s degree within relevant field of expertise e.g. toxicology, veterinary medicine, pharmacology. PhD and other certifications are highly preferred
10+ 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
Why Join Hemab
Make a meaningful difference for patients with serious and underserved conditions
Work in a collaborative, trust‑based culture with a strong scientific focus and team spirit
Be part of a growing international biotech with high ambitions
#J-18808-Ljbffr