Chief Medical Officer directs the staff and develops policies for the organization's clinical programs. Works closely with hospital staff, department directors, and physicians to ensure that the highest standards of quality and service are maintained. Being a Chief Medical Officer oversees the implementation of quality improvement efforts designed to improve clinical performance and maintain compliance with HIPAA and other regulations and standards. Evaluates developments and innovations in medical care and makes recommendations for new practices and procedures. Additionally, Chief Medical Officer advises CEO and medical teams on matters impacting patient care. Requires a MD. Requires State License to Practice Medicine. Typically reports to top management. The Chief Medical Officer manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)
Alpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!
Alpine Immune Sciences seeks a Chief Medical Officer with a track record of success in life science enterprise leadership to help the company realize its potential for patients, their families and its stakeholders.
Responsibilities:
• Develop and implement clinical development plans. Integrate and oversee all departmental activities, ensuring alignment with corporate strategy.
• Formulate and conduct innovative clinical programs of appropriate scope that fulfil regulatory requirements and support business plans.
• Guide clinical staff in executing the clinical development programs set forth in approved clinical plans.
• Identify and recommend potential new research or development projects and assess the feasibility of pursuing these projects.
• Maintain state-of-the-art knowledge of the principles and theory in relevant therapeutic areas.
• Initiate and/or direct contacts with experts in related specialty areas to further the progress of clinical development projects.
• Direct and participate in the preparation of INDs, NDAs, study reports and other regulatory documents as appropriate.
• Develop and/or assist in the production of clinical documents required for the conduct of clinical studies, such as clinical protocols, informed consent documents, investigator’s brochures, and safety management plans in compliance with federal regulations and good clinical/medical practices.
• Safety data review and management of internal/external data monitoring committees.
• Provide ongoing data interpretation and medical writing of study reports, conference abstracts, and manuscripts for publication.
• Present clinical program at Site Initiation Visits, Investigator’s Meetings and scientific conferences.
• Serve as a key clinical and medical voice of Alpine Immune Sciences to investors and other external stakeholders.
• Provide senior scientific support to Business Development as needed.
Qualifications & Experience:
• Physician with a deep track record in the development, registration and commercialization of new drugs.
• Subject matter expertise in immunology/inflammation a strong plus. Also valued is a strong reputation within the industry.
• Experience writing technical documents, such as protocols, clinical study reports, and clinical sections of IND/NDAs/BLAs.
• Team player with executive presence and demeanour coupled with excellent written and verbal communication skills as well as outstanding analytical abilities
• Prior experience at senior levels working in and/or leading cross-functional teams with demonstrated ability to align with and execute on commercial and scientific goals and objectives. Ability to thrive in high-growth environment.
• Demonstrated ability to interact with strategic partners, including biopharma collaborators in the U.S. and internationally.
• Competency in contributing to and/or reviewing promotional material and learning materials for both internal and external use.
• Working knowledge of biostatistics as relevant to the design and analysis of clinical trials.
• Familiarity with OPDP, PhRMA code, and key regulations in the pharmaceutical industry.
• Sense of mission with a dedication to patients and their families.
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Alpine is flexible as to the location of the Chief Medical Officer. That said, the company’s headquarters is in Seattle and several key leaders within the clinical departments reside in the Bay Area (Alpine may open a Bay Area site next year). Alpine’s leadership values coming together regularly for in-person engagement and interaction. Travel to Seattle and possibly the Bay Area would be expected along with other travel inherent in such a role.
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.
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. Onsite employees enjoy an open-office layout with 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!
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