Join the team at Aro Biotherapeutics creating breakthrough biotherapeutics based on Centyrin oligonucleotide conjugates. Centyrins are small protein domains based on the fibronectin domains of human Tenascin C that combine the affinity and specificity properties of antibodies with the stability and tissue penetration properties of small molecules. We have engineered Centyrins with an array of specificities for normal and immune cell receptors. Engineered for high stability in the absence of disulfides, multi-specific Centyrins are readily expressed and purified from E. coli or mammalian cells. Conjugation of oligonucleotides is achieved by introduction of a unique cysteine at well characterized sites in the Centyrin backbone.
We are developing a platform for delivery of an array of intracellularly active payloads with a focus on oligonucleotides. Our team has built a strong set of in vitro and in vivo data validating the utility of Centyrins for receptor specific uptake in a variety of cell types. Centyrin conjugate mediated delivery provides the foundation for access to a set of intracellular targets that have long been considered undruggable.
Aro is building a wholly owned portfolio of Centyrin oligonucleotide conjugates for genetic and autoimmune diseases and developing a partnered portfolio of Centyrin conjugates for payload delivery in a variety of disease areas. Led by an experienced and exceptional team, Aro is backed by an exceptional syndicate that supports our commitment to advancing drug candidates with the potential to improve patient’s lives and to building an ideal environment for scientific and leadership growth.
Preclinical Pharmacology and Development Lead
This role reports to the Vice President of Clinical Pharmacology and Nonclinical Development will have advanced understanding in the following areas.
- Represent Nonclinical Development as the subject matter expert providing expertise and guidance on preclinical pharmacology studies including ADME and pharmacodynamics.
- Design and execute preclinical studies to understand the pharmacology, pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of drug candidates
- The primary contact to manage, guide, and execute these studies in CROs, ensuring studies are completed to meet program objectives and timeline, and with the quality consistent with regulatory standards and guidelines (FDA, EMA, GLP, and GCP)
- Responsible for the analysis, interpretation, integration and reporting of preclinical pharmacology ADME data generated both internally and externally
- Collaborate with Clinical Pharmacology to develop quantitative tools to translate PK/PD relationship from preclinical to clinical using modeling and simulation (M&S)
- Prepare strategic and scientifically sophisticated Pharmacology/ ADME strategies that meet regulatory requirements and program goals.
- Author high quality Regulatory documents including INDs, CTAs and NDA filings.
Qualifications
- Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics other relevant field with >7 years of experience in the biopharmaceutical industry, with evidence of drug development experience.
- Strong knowledge of pharmacology, drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles is required.
- Experience in pharmacology and metabolism aspects of oligonucleotides (e.g., ASO, siRNA, etc.) is highly desirable
- Excellent knowledge and hands-on skills building translational PKPD models is highly desirable
- Experience using WinNonlin or other pharmacokinetic software required
- Strong communication (verbal and written) and presentation skills required
- Excellent interpersonal skills and ability to represent DMPK in a team environment are essential
- Prior experience with regulatory submission (e.g., IND, BLA and/or NDA) is a plus
Aro Biotherapeutics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, gender identity/gender expression, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
Aro Biotherapeutics offers a competitive benefits package including:
- A variety of health insurance options at competitive rates
- Flexible Spending Accounts
- Paid Time off, including personal and vacation time
- Company holidays
- 401(k) with company match
- Disability and Life Insurance
- Commuter Benefits
- Employee training and development opportunities
- And more!
Aro Biotherapeutics is an equal opportunity employer; all qualified applicants will be considered for employment without regard for any characteristic protected by law. Aro Biotherapeutics provides a competitive benefits package.