As a Senior Director / VP Toxicology you will play a key role in a cross-functional team responsible for planning and managing the non-clinical safety, pharmacology and toxicology programs for products across Hemab’s portfolio. In this position you will be responsible for the strategy, planning and oversight of all required studies to enable rapid advancement into and through regulatory filings and will work closely with colleagues and key external consultants across all functional disciplines.
Essential duties and responsibilities to perform this job successfully include, but are not limited to, the following:
- Provide strategic direction and ensure execution of non-clinical efforts across multiple programs from discovery through clinical development
- Collaborate with internal project teams and leadership to develop and drive integrated non-clinical safety, pharmacology, and toxicology strategies to support development projects
- Support the design of in vivo and in vitro safety studies as needed to identify and mitigate treatment-related toxicities in early discovery stage projects
- Establish strategic partnerships with contract research organizations (CROs) and providing oversight to key aspects of studes as needed
- Finalize efficacy and toxicology reports and all sub-vendor reports
- Prepare toxicological risk assessments to support drug development and manufacturing
- Work closely with internal project teams and vendors in the transfer of in-house assays and the development of novel biological assays
- Provide strategic advice to project teams and senior management on the potential impact of toxicology results on program, indication and clinical/regulatory strategies
- Work closely with colleagues in clinical development to support and defend clinical trial design plans
- Write or oversee the writing of the in vivo pharmacology, toxicology, and DMPK sections of an IND, the toxicology and safety section of Investigator Brochures and represent in vivo pharmacology and toxicology in regulatory authority meetings
- Support the preparation of national and international regulatory submissions and interactions with governments
- Participate in consultation with the Chief Medical Officer, clinical colleagues, Regulatory Agencies and clinical investigators about study design to support clinical trials
- Manage direct reports, as assigned
- Perform other related duties as assigned or directed
Professional competencies:
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 accomplishments within toxicology
- Comprehensive theoretical and technical understanding of animal husbandry, and a wide range of in vivo approaches and technologies
- Recognized as expert within chosen field of animal research, and well-established network of contacts with key opinion leaders and academic scientists
- 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 pre-clinical and clinical development
- Flexible team-player excited to collaborate with internal and external partners
- Familiarity with the range of IT software programs typically utilized in a biotech environment
Education and/or experience:
- PhD in toxicology, pharmacology or related field with a minimum of 15 years of relevant experience
- 10+ years of experience in technical, scientific, and regulatory aspects of non-clinical safety evaluation of biologics
- 5+ years of related experience leading and managing a team
- Proven ability to design, manage and interpret non-clinical studies in rodent and non-rodent (NHP) species
- Experience in developing toxicology programs to support early and late stage drug development with a comprehensive understanding of the interplay between non-clinical safety, pharmacology, biomarkers, DMPK, formulations and process change
- Experience with investigative toxicology including proven ability to research and develop strategy around novel findings
- Extensive experience interfacing with, and providing scientific guidance to CRO partners and proven ability to work efficiently in a hybrid model
- Experience interacting with worldwide regulatory agencies and authoring regulatory filings
- Ability to integrate data across disciplines and communicate salient data to executive leadership and/or a broad audience
- Experience in incorporating pharmacokinetic endpoints in toxicology programs and a working knowledge of the software programs to achieve these endpoints
- Experience with global regulatory guidance documents (ICH /FDA) and Good Laboratory Practices (FDA and OECD)
- Strong oral communication skills and demonstrated proficiency at technical writing
- Ability to prepare relevant sections of regulatory filings such as INDs/CTAs
- Capability to manage multiple projects and shifting priorities associated with an early stage drug development company
- Proven success in supporting cross-functional project teams and ability to collaborate in a cross-functional matrixed organization
Hemab Therapeutics 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.
