Altavant Sciences (Altavant.com) is a patient-centric, clinical stage biotechnology company focusing on innovative therapies for rare respiratory diseases. Altavant is seeking a Director / Senior Director with expertise in immunology to join the translational medicine team. The successful scientist will have a strong track record in drug discovery and development addressing immune and inflammatory pathways, and how their dysregulation can contribute to acute and chronic disease processes.
This role will report directly to the VP, Research and Development and will be responsible for leading nonclinical programs, nonclinical studies, internal teams, and managing external vendors in progressing the development of small and large molecule therapeutics.
This scientist will be based within the translational medicine team and will interface with other teams including clinical to provide expertise for clinical study design and medical liaison activities.
Altavant is based in Cary, North Carolina; however, the position is open to candidates wishing to work remotely augmented with visits to the office for key meetings or team discussions after Covid-related travel restrictions are lifted. Altavant does not have laboratories and performs research and development studies at qualified vendors or as collaborations with academic institutions.
RESPONSIBILITIES & SKILL REQUIREMENTS:
- Design, implementation, oversight and interpretation of in vitro primary cell-based assays and nonclinical in vivo disease models. This will include selection of clinically-relevant endpoints, selection and qualification of biomarkers, translation of findings to characterize mechanism of action, predict human equivalent doses, and inform clinical study design – particularly those establishing proof-of-concept.
- Support development, qualification/validation, and application of immunoassays.
- Design and development of robust nonclinical data packages to support IND and BLA submissions.
- Author nonclinical pharmacology and immunology sections of regulatory filings.
- Author and review meeting abstracts and manuscripts for publication in peer-reviewed journals.
- Contribute to exploratory target and biomarker identification and qualification/validation.
- Participate in the review of business development opportunities.
EDUCATION AND EXPERIENCE:
- Ph.D. in immunology or related discipline with major immunology component, with a minimum of 5+ years of biopharmaceutical development experience.
- Experience in respiratory drug development is desirable but not required.
- In depth expertise on innate and adaptive immunity including an understanding of immune regulation, lymphocyte and cytokine biology, and the consequences of chronic and dysregulated inflammatory responses.
- Track record in supporting nonclinical development programs for large (biological) therapeutics including an understanding of Regulatory Agency expectations is desirable.
- Experience with techniques used for biopharmaceutical characterization and development of biologics including: qPCR, SPR, immune cell isolation and characterization by multi-parameter flow cytometry (Cytobank, FlowJo, MACS) and other in vitro functional assays, immunoassays including multiplex, cytokine assays, immunohistochemistry, and structure-function relationships for therapeutic proteins.
- Experience in data analysis to support pharmacokinetics (PK) and PK-pharmacodynamics (PK/PD) is desirable, as is broad experience of all functional areas of early drug development including toxicology, nonclinical pharmacology, drug metabolism, translational biology, and Phase 1/2 clinical development.
- Experience in authoring non-clinical regulatory submission documents (e.g. IND, NDA/BLA, IBs).
- Strong communication skills, including ability to communicate (verbally and in writing) technical and non-technical information clearly to a diverse audience.
- Developing track record of publications including peer reviewed manuscripts, abstracts and poster/oral presentations.
- Proven ability to work at a high level of integrity, accuracy, and attention to detail.
- Ability to make thoughtful, integrated, timely and meaningful recommendations and/or decisions and take corresponding actions.
- Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships to strengthen decision-making.
- Resourceful, enthusiastic, and results-oriented.
- Ability to travel up to ~15% as needed when Covid-related restrictions expire. Travel will mostly comprise visits to the Altavant office if working remotely, conference attendance and study-related visits to vendor laboratories.