$250K — $500K+*
Alpine Immune Sciences is applying our platform discovery technology to bring innovative new therapies to people living with serious or life-threatening illnesses or conditions, such as cancer and autoimmune/inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!
Responsible for oversight and direction of translational development functions in support of all of the Company’s therapeutic candidates, including first-in-human enabling nonclinical studies (e.g. toxicology, DMPK) for late preclinical programs, and all other related activities in support of the portfolio, including companion diagnostics, clinical pharmacology, biomarkers, target indication rationale, and pharmacodynamics, as required. Works closely with key internal and external stakeholders to enable the rapid and efficient assessment of all development objectives.
• Oversight of clinical pharmacology and preclinical DMPK, nonclinical toxicology, companion diagnostics and biomarkers.
• Responsible for development of translational strategy as well as implementation and analysis, utilizing cross-functional and -departmental resources.
• Contributes to the development of comprehensive, cross-functional Therapeutic Product Profiles and Product Development Plans, as appropriate based on a given asset’s unique attributes, including appropriate input from stakeholders within clinical development, CMC, regulatory, research, IP and commercial.
• Contributes to the design and implementation of comprehensive nonclinical and clinical development plans, incorporating appropriate nonclinical and clinical studies with sufficient size and scope to enable efficient, confident milestone decisions
• Contributes to the design and implementation of preclinical and translational models to enable target indication selection and guide lifecycle development
• Key responsibility for nonclinical development and early clinical portfolio and program strategy including recommendations regarding ‘go/no-go’ decisions related to further development of assets, particularly when based upon diagnostic, biomarker or other pharmacodynamic endpoints.
• Direct line management and mentorship of subject matter experts for critical translational functions.
• Organizes scientific advisory board meetings as needed.
• Proposes, evaluates, selects, and manages vendors and consultants
• Supports corporate compliance and GLP/GCP
• PhD and/or MD or equivalent with direct experience in oncology, hematology, rheumatology, or other immunologically-relevant discipline
• 10+ years of experience within the pharmaceutical/biotechnology industry, with proven ability to manage and work in cross-disciplinary teams effectively and successfully
• Proven success with development of oncology and/or immunology assets from a translational perspective. Successful experience with first-in-human activities (including INDs) of biologics is required. EOP2/BLA/MA experience is desirable.
• Proven success with development of companion diagnostics (including IDE), preferably immunohistochemistry- or tissue-based. Experience with flow or mass cytometry and other forms of immunophenotyping is strongly desired, as is PMA experience.
• Proven facility with the use of bioinformatics and other genomic-volume datasets for the development of critical, decision-enabling biomarkers or PD markers for clinical use. Proficiency with analysis methodologies (e.g. Spotfire, Tableau, R, SAS) is strongly desired.
• Highly advanced knowledge of nonclinical and clinical development processes
• Strong knowledge of ICH, GCP, and FDA, EMEA, and Asian regulatory requirements
• Ability to operate successfully (develop strategy, execute on plans, achieve goals, make decisions, hire and mentor team) in fast-paced, start-up environment
• Excellent communication, collaboration and leadership skills
Alpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.
Our treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpine’s culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.
We take care of our employees with competitive benefits package which includes premium medical, dental, and vision coverage for employees and their dependents, wellness programs, FSA and 401(k) plans. We believe that quality time outside the office is vital to our employees’ satisfaction at work. That’s why our flexible PTO plan encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).
Alpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Our office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy during the COVID pandemic. Onsite employees enjoy comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.
Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!
Valid through: 10/27/2021
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