Executive Director, Early Phase, Clinical Pharmacology, Client Engagement Experience

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $193.6k - $367.8k / year

⏰ Full Time

🔴 Lead

👔 Director

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Operate as a subject matter expert in one or more indications • Support talent identification, hiring, development, and management of key medical staff • Serve as Medical Lead in asset-level or portfolio-level governance activities • Lead interdivisional and cross-divisional activities supporting corporate objectives and business development opportunities • Provide medical oversight for assigned clinical studies as a medical monitor • Serve as primary medical contact for customers and functional lead for medical colleagues • Provide medical input and oversight to Drug Safety and Pharmacovigilance • Design protocols and provide input into protocol amendments • Develop and deliver therapeutic and project-specific training • Provide medical and therapeutic input to study start-up, feasibility, and subject identification activities • Provide medical input into data collection tools, monitoring plans, and review and analysis plans • Oversee Medical Scientist and Medical Director colleagues reviewing clinical data • Present trends, issues, and mitigation strategies to customers and project teams • Provide after-hours coverage to clinical studies • Adhere to enterprise, customer, and project policies and procedures • Lead medical responses to RFPs and RFIs and formulate Bid Defense Meeting strategies • Teach and supervise medical staff conducting proposal activities • Contribute to product and clinical development plans and regulatory submissions • Locate and engage external experts, consultants, and advisors • Represent Syneos Health at scientific and industry meetings • Publish scientific or industry-related articles when requested • Participate in or self-identify BU and cross-functional process improvement initiatives

🎯 Requirements

• Subject matter expertise in one or more indications • Experience as a Principal Investigator (PI) or Sub-Investigator (Sub I) preferred • Client engagement experience preferred • Experience identifying, hiring, developing, and managing medical staff • Ability to manage multiple individuals and supervise multiple levels of staff • Senior medical leadership experience in clinical studies or programs • Medical oversight experience, including medical monitoring • In-depth knowledge of FDA and worldwide drug development regulations • Knowledge of national and ICH Good Clinical Practice (GCP) guidelines • Experience leading medical responses to RFPs and RFIs • Experience formulating strategies for Bid Defense Meetings • Experience contributing to product and clinical development plans, regulatory submissions, and related applications • Equivalent experience, skills, and/or education may be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Company car or car allowance • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time