Medical Director

Company: Skills Alliance
Location: Seattle
Posted on: May 16, 2022

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