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Associate Medical Director/Director, Clinical Development-(Nephrology)

LocationRemote; Seattle, WA, USA
Salary$225,000 - $260,000 for an Associate Medical Director, and
CommitmentFull time
RoleClinical Science
Remote🌴Remote allowed
First listedIn the last 4 months

Job Description

Alpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!

The Associate Medical Director or Medical Director will 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 function as consultant/liaison with other corporations when working under licensing agreements.

Duties and responsibilities

· 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.

Qualifications

· M.D with board certification or eligibility, specialized in Nephrology, Rheumatology, or Neurology is preferred.

· At least 5 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 conducting 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 Alpine.

· 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.

· This position anticipated up to 25% travel.

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