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