Medical Director
Company: Skills Alliance
Location: Seattle
Posted on: May 16, 2022
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Job Description:
We are actively partnered with a clinical stage
biopharmaceutical company dedicated to discovering and developing
novel, protein-based immunotherapies with a robust development
pipeline. Using their proprietary scientific platform to convert
native immune system proteins into differentiated, multi-targeted
therapeutics they aim to significantly improve outcomes in patients
with serious diseases.
Our Client is seeking a Medical Director - Senior Director -
Executive - VP to oversee the direction, planning, execution and
interpretation of clinical trials and data collection activities
for multiple programs in the development portfolio. The individual
in this role will establish and approve scientific methods for
design and implementation of clinical protocols, data collection
systems and final reports. Together with the Clinical Trial
Manager, may recruit clinical investigators and negotiate study
design and costs. They will be responsible for directing human
clinical trials, phases I - IV, for company products under
development. Responsibilities also include adverse event reporting
and safety responsibilities monitoring. Coordinates and develops
information for reports submitted to the Food and Drug
Administration and other health authorities. Monitors adherence to
protocols and determines study completion. May act as
consultant/liaison with other corporations when working under
licensing agreements.
What You'll Do:
Provide medical monitoring to multiple clinical trials.
Lead project teams to design and implement clinical studies.
Write protocols, investigator brochures, clinical study reports and
review clinical trial documents.
Conduct investigator meetings and lead site initiation visits with
clinical trial investigators.
Execute and deploy drug development strategic plans, develop
contingency plans, provide technical and strategic advice, and meet
milestones and budgets.
Translate findings from research and nonclinical studies into
clinical development opportunities.
Interact with clinical investigators and thought leaders.
Work with internal regulatory affairs team and other ethical
guidelines relevant to the pharmaceutical industry, and ensure
compliance with these external guidelines.
Work with internal pre-clinical scientists, translational
scientists, safety physicians, business and commercial
organizations in a cross functional manner.
Work in a team environment comprising clinical operations,
biomarker specialists, CROs, and regulatory affairs.
Perform other duties as required.
What You'll Bring:
M.D. or D.O. degree and experience managing clinical trials
required.
At least 3 years of relevant drug development experience, either
within industry or as a clinical investigator/physician scientist
in academia, or equivalent experience.
Proven clinical development strategist with experience designing,
implementing and conducting clinical trials
Knowledge of carrying out clinical trials, including knowledge of
current treatment landscapes; ; experience with clinical trials in
systemic lupus erythematosus useful
Strategic leadership and tactical skills, excellent initiative and
judgment, and demonstrated ability to positively represent the
goals of the organization.
Demonstrated ability to develop and maintain excellent working
relationships with both internal colleagues and external contacts,
including key thought leaders, and investigators.
Demonstrated ability to work well in teams in a cross functional
manner.
Ability to communicate and work independently with
scientific/technical personnel with excellent oral presentation
skills.
Ability to think critically, and demonstrated troubleshooting and
problem solving skills.
Comfortable in a fast-paced small company environment with minimal
direction and able to adjust workload based upon changing
priorities.
Prior to the SARS-CoV-2 pandemic, this position anticipated up to
25% travel; during the interim prior to re-establishment of safe
travel, skills at virtual communication are required.
Our client 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. They are also committed to compliance with all fair
employment practices regarding citizenship and immigration
status.
Keywords: Skills Alliance, Seattle , Medical Director, Executive , Seattle, Washington
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