Senior Scientist/Director - Toxicology and preclinical safety
Omniox, Inc. is an IND-stage biopharmaceutical company developing a proprietary protein platform to treat diseases where hypoxia and ischemia drive poor clinical outcomes, such as cancer, stroke and critical care. We have strong financial sponsorship from leading investors.
We are looking for a highly motivated Sr. Scientist/Director of Preclinical Toxicology with relevant experience in preclinical toxicology, PK/PD and safety studies in biotherapeutic drug development, preferably in pharma or biotech company. The ideal candidate will have 5+ years of industry experience in overseeing exploratory and phase appropriate pharmacokinetic and toxicology studies and development of necessary assays and documentation, in support of IND submissions and clinical programs.
The candidate will be expected to work both independently and as a part of a highly collaborative group. As part of a multidisciplinary team, this individual will have an excellent opportunity to contribute to and be exposed to the full scope of biopharmaceutical product development.
Job title will be determined based on the level of experience.
As an Omniox team member, you will support our corporate values of:
- Scientific and operational excellence
- Open-mindedness and courage
- Provide scientific oversight for nonclinical safety studies, including genetic toxicology, general toxicology, safety pharmacology, developmental and reproductive toxicology, and carcinogenicity studies
- Work with Chemistry, Manufacturing, and Controls (CMC) to address impurity-related issues for regulatory needs
- Design, implement, interpret, and report phase appropriate pharmacokinetic, ADME, reproductive toxicology, and in vivo drug-drug interaction studies
- Provide pharmaceutical drug project teams with expert advice and direction to improve the quality of therapeutics selected for further development based on proactive risk assessment of drug-related toxicities
- Work closely with internal functional groups such as Pharmacology, CMC, Regulatory Affairs, Clinical Development, and Project Management, and actively participate in team strategy discussions for drug development programs
- Participate in the preparation of preclinical texts for worldwide regulatory submissions, including authoring the nonclinical safety components of regulatory dossiers (e.g. IB, INDs, NDAs) and communications as well as responses to inquiries from regulatory agencies
- Effectively oversee and manage Contract Research Organizations (CROs) and vendors used for Toxicology and nonclinical development studies for Omniox projects
- Present key findings and influence thinking of program teams, R&D leadership, and regulatory authorities
- PhD in pharmacology/toxicology or related discipline plus a minimum of 5 years’ experience (or MS plus a minimum of 10 years’ experience) with the conduct and submission of nonclinical safety evaluation studies in the biotech/pharmaceutical industries
- Board certification (DABT) is desirable but not required
- Broad understanding of nonclinical safety evaluation and drug development
- Ability to interpret and integrate complex data sets across multiple disciplines including pharmacology, DMPK, analytical methods, toxicology, and pathology assessing the clinical relevance and impact
- Experience with in vitro assays utilized for assessment of toxicological risks
- Familiarity with regulatory toxicology guidelines, requirements, and standards (GLP, OECD, ICH, CTD, etc.) and able to develop nonclinical strategies that support clinical development
- Experience authoring nonclinical components of regulatory dossiers and interacting with US and worldwide regulatory agencies
- Hands-on experience in design and management of non-clinical studies in support of regulatory applications
- Strong knowledge of toxicology, drug metabolism, and pharmacokinetics
- Strong interpersonal skills and ability to effectively manage external consultants and third-party CROs
- Strong critical thinking skills, oral/written communication skills and project management skills
- Prepared to work in the highly dynamic environment of an early stage biotech company, be able to accommodate flexible working hours and work on weekends and during holidays.
We offer competitive compensation, including base salary + bonus, stock options, health benefits and paid time off.
Please send your resume and cover letter to firstname.lastname@example.org
Omniox is an equal opportunity employer. We will consider all qualified applicants without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.