Chief Medical Officer

Company: U.Group
Location: Seattle
Posted on: February 20, 2021

Job Description:

Clinical Development - Clinical Development / 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! Alpine Immune Sciences is seeking a Chief Medical Officer to be a key member of the company's executive team, which determines and sets the overall strategic direction of the company. The CMO will work closely with a passionate team and provide leadership and direction for all clinical development programs in the company's pipeline. The CMO will be responsible for the strategy, direction and execution of the company's clinical development plans. Alpine Immune Sciences is a clinical stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies targeting the immune synapse to treat cancer and autoimmune and inflammatory diseases. We have two products in the clinic for inflammatory diseases and cancer, collaborations with world-class partners, and a robust development pipeline. We use our proprietary scientific platform to convert native immune system proteins into differentiated, multi-targeted therapeutics with the potential to significantly improve outcomes in patients with serious diseases. This is a rare opportunity to join an early stage, public, biotechnology company developing next-gen therapies.-- Primary Responsibilities: -Responsible for all major phases of clinical development. Sets and directs the strategy for all clinical development activities. Establishes the conditions essential for determining the safety, efficacy, and marketability of product candidates. -Directs and/or contributes to all therapeutic product profiles to guide translational and commercial development plans to integrate compounds into relevant therapeutic areas. -Directs and/or contributes to all companion diagnostic and biomarker strategies and/or operations relevant to all clinical development programs -Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities -Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results -Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders -Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy -Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners -Responsible for hiring and managing appropriate full-, part time-, and/or contract personnel, including--clinical research, pharmacology, biometrics, clinical operations, and pharmacovigilance, as appropriate and agreed upon with the executive committee Requirements: -MD or equivalent with active board certification in hematology/oncology, rheumatology, immunology or other related subspecialization. Contemporary clinical practice experience in immuno-oncology or autoimmune diseases desired. -15 years minimum experience in pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugs, including the implementation of companion diagnostics. -Multiple years of management experience leading a clinical group including clinical/medical affairs, clinical operations, biometrics, and pharmacovigilance. -Proven success record in Phase I-IV clinical research studies and trial design, including successful submission of IND's and marketing approval-directed filings (BLA's, NDA's, and MAA's), as well as IDEs and related diagnostic or device approval filings (e.g., PMA's). -Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA and EMA is essential; experience in interactions with other health authorities strongly desired. -Experience with drug development in oncology and/or inflammatory diseases. Experience or knowledge of orphan disease drug development a plus -Proven experience in translational medicine, clinical pharmacology and early stage development -Excellent knowledge of the competitive environment for drugs in the hematology/oncology, rheumatology and related therapeutic areas.-- -Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines. -The successful candidate will read, write and speak fluent English, possess excellent communication skills and will be capable of articulating the Company's clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, Company employees, and the investor community. -Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company; must have outstanding executive presence. -Must be science- and data-driven -For best fit, the candidate must have the ability and strong desire to be "hands on". Must have a results-oriented work ethic and a positive, can-do attitude. Effective leadership, people management, communication skills and a team builder management style are essential. 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 have weekly get-togethers at local beer halls, a casual and stocked breakroom, monthly company lunches, peer-to-peer recognition programs, weekly fitness and yoga classes, 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. Exciting challenges lie ahead-guided by our core values, we'll meet these challenges. Join us!

Keywords: U.Group, Seattle , Chief Medical Officer, Executive , Seattle, Washington