Director, Clinical Science

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $191k - $286k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Lantheus

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1956

With more than 65 years of experience in delivering life-changing science, Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease. Lantheus is headquartered in Massachusetts and has offices in Canada and Sweden.

📋 Description

• Responsible for the relevance and accuracy of clinical development planning and guidance for a clinical study. • Contribute to authoring and lead design/reviews of key product and study-related documents and deliverables. • Responsible for the oversight of clinical study execution as clinical lead. • Works with investigative sites and/or study teams to answer protocol related questions. • Reviews clinical data listings, patient profiles and summaries to ensure data collection, data interpretation and data reporting proceeds in a manner consistent with the protocol. • Prepare and may present protocol designs, clinical data and other information at advisory boards, investigator meetings, site initiations and other internal and external settings. • Supports regulatory interactions and the development of clinical sections for regulatory correspondence and submissions.

🎯 Requirements

• Advanced Degree preferred (e.g. MD, PhD, or PharmD). • 7 - 10 years of relevant experience in pharmaceutical industry in clinical development preferred. • Oncology and/or Radiopharmaceutical clinical development experience preferred. • Clinical development experience across all phases of development (I - III). • Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors. • In-depth knowledge of regulatory guidelines and ICH/GCP. • Experience in developing and writing study protocols, clinical study reports and other study documents. • Excellent verbal and written communication skills with ability to work across functions in multifunctional matrix environment.

🏖️ Benefits

• Comprehensive health benefits package including medical, prescription drug, dental, and vision coverage. • Life and disability benefits. • Pre-tax accounts. • 401(k) with company contribution. • Generous time off package including paid vacation, holidays, sick days, and paid parental leave.