Associate Medical Director – Medical Director

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the medical monitor for designated clinical trials throughout their entire lifecycle.

• Offer medical and scientific expertise for the execution and supervision of clinical trials.

• Ensure the safety of patients, compliance with regulations, and the integrity of scientific data.

• Evaluate adverse events, serious adverse events, and deviations from the protocol.

• Collaborate with pharmacovigilance teams to analyze safety signals.

• Provide direction on patient eligibility and adherence to protocols.

• Draft study protocols, amendments, Investigator Brochures, informed consent documents, and clinical study reports.

• Analyze and interpret clinical trial data for safety, effectiveness, and precision.

• Assist with interactions with regulatory agencies, submission documentation, and regulatory meetings.

• Build strategic relationships with key opinion leaders, centers of excellence, and patient advocacy groups.

• Create content for advisory board meetings.

• Prepare abstracts, scientific symposium presentations, and manuscripts for peer-reviewed publications.

• Monitor standards of care and experimental treatments by reviewing literature and attending professional meetings.

⛳️ Requirements

• MD or PharmD with clinical oncology experience and a background in biotech/pharma oncology drug development preferred.

• PhD with at least 3 years of experience in biotech or pharmaceutical oncology drug development.

• Experience serving as a medical monitor during clinical trials, including reviewing patient eligibility, interacting with sites to ensure protocol compliance, reviewing protocol deviations, and conducting clinical data reviews and cleaning activities.

• Proven experience in executing clinical studies, including engaging with regulatory agencies.

• Exceptional written and verbal communication abilities.

• Capability to effectively collaborate within cross-functional teams, both internally and externally.

• Outstanding organizational and time management skills, with a keen attention to detail.

• Demonstrated ability to manage multiple tasks efficiently and effectively.

• Innovative problem-solving skills with a proven track record of proactive action.

• Currently authorized to work in the United States.

• Must not require visa sponsorship now or in the future.

🏝️ Benefits

• Company-sponsored healthcare.

• Flexible spending accounts.

• Voluntary life insurance.

• 401K matching.

• Unrestricted vacation policy.

• Onsite gym facilities.

• Onsite dining options.

• Brand-new, state-of-the-art facility.

• Convenient access to excellent living and recreational areas.