Working at Altavant

Altavant is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law.

See current job openings at Altavant Sciences below.

Director/Senior Director Immunology 

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).

CAPABILITIES:

  • 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.

Please CLICK HERE to apply to this role (https://www.linkedin.com/jobs/view/2652017129/?capColoOverride=true).

Senior Director, Head of Program Management 

Altavant is seeking a Senior Director of Program Management. This role will report directly to the SVP, Business Operations and will be responsible for overall management of the programs in Altavant’s portfolio.  This person must have extensive drug development experience.  They will be a key contributor to setting strategy and a critical leader in the planning, execution and monitoring of tactics and operations for the development of life-saving medicines for patients with rare respiratory diseases.  

RESPONSIBILITIES & SKILL REQUIREMENTS:

  • Contribute to the creation, analysis, and refinement of drug development strategies for multiple programs
  • Create and update program timelines, in collaboration with teammates from Clinical, Nonclinical, Regulatory, and CMC functions
  • Maintain program budgets in partnership with Accounting and Finance teammates
  • Facilitate Program Team Meetings to ensure timely decision making, a full understanding of progress and interdependencies between teams, and tracking of emerging issues on the programs
  • Prepare materials to visualize program and budget status and forecasts for use by the team, including Senior Executive members

EDUCATION AND EXPERIENCE:

  • BS/BA (minimum); MS, MBA and/or PhD (preferred)
  • >15 years of experience in pharmaceutical industry with broad exposure to all functions/activities (Nonclinical, Clinical, CMC and Regulatory) involved in drug development
  • >10 years of project management experience in drug development
  • Proficient with Microsoft Excel, PowerPoint, Project and Office Timeline or similar visualization application
  • Demonstrated experience working with cross-functional teams, outsourcing partners, and consultants, preferably with experience working in a small pharma/biotech organization
  • Knowledge of global (FDA, EMA, PMDA) regulatory requirements for small molecule and/or biologic drugs
  • Demonstrated experience or knowledge with cost management and forecasting

Preferred but not required:

  • Project management in the respiratory therapy area
  • PMI certification

CAPABILITIES:

  • Strong communication skills, including ability to communicate (verbally and in writing) technical and non-technical information clearly to a diverse, remote audience
  • 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

Please CLICK HERE to apply to this role (https://www.linkedin.com/jobs/view/2708555528/?capColoOverride=true).

Senior Director Nonclinical Development 

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 nonclinical drug development to join the Translational Medicine team. The successful scientist will have a strong track record of achievement in drug discovery and development for small and large molecule therapies. Experience in respiratory indications and inhaled delivery would be ideal.

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. Grade will be determined based on experience.

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 and develop robust nonclinical data packages to support IND, NDA and BLA submissions.
  • Lead nonclinical programs and studies covering pharmacology, drug metabolism, pharmacokinetics, and toxicology disciplines.
  • Design, implement, oversee, and interpret in vitro DMPK and pharmacology assays, including mechanistic primary cell-based assays and nonclinical in vivo disease models. The pharmacology studies 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 bioanalytical assays.
  • 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. with 15+ years of industry experience in nonclinical drug discovery and development.
  • Track record in supporting nonclinical development programs for small and large (biological) therapeutics.
  • Experience in respiratory drug development and inhaled delivery is desirable but not required.
  • In depth knowledge of Regulatory expectations supporting milestone stages in the nonclinical development of new medications.
  • Technical experience or understanding of bioanalysis using LC-MSMS and immunoassays.
  • Experience in data analysis to determine pharmacokinetics (PK). Experience in PK-pharmacodynamics (PK/PD), physiology-based PK modelling is desirable.
  • Experience in authoring non-clinical sections of regulatory submission documents (e.g. IND, NDA/BLA, IBs).

CAPABILITIES:

  • Strong communication skills, including ability to communicate (verbally and in writing) technical and non-technical information clearly to a diverse audience.
  • Ability to think strategically and execute tactically. Resourceful, enthusiastic, and results oriented.
  • 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.
  • 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.

Please CLICK HERE to apply to this role (https://www.linkedin.com/jobs/view/2764470186/?capColoOverride=true).