Company: Skills Alliance
Posted on: June 25, 2022
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
- 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
- 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
- Ability to communicate and work independently with
scientific/technical personnel with excellent oral presentation
- 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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