Key Responsibilities:
Portfolio Leadership : Oversee the clinical development portfolio and expand the pipeline with new product candidates and indications, including supporting Business Development efforts to maximize product value.
Clinical Development Oversight : Lead all U.S. clinical research and development functions from Pre-IND through Phase 4, guiding the clinical team and managing cross-functional teams for trial execution.
Operational Strategy : Direct strategic planning and execution for U.S.-based clinical trials, ensuring alignment with regulatory and operational goals.
Regulatory and External Engagement : Act as a senior scientific representative for the company, participating in regulatory interactions and building relationships with key opinion leaders.
Cross-Functional Collaboration : Partner closely with Research, Commercial, Regulatory, and Pharmacovigilance teams to drive the clinical trial strategy and expand our pipeline.
Proven leadership in pharmaceutical drug development, encompassing clinical trial management, regulatory submissions, post-launch studies, and GCP.
Extensive experience in all phases of drug development, including NDA submissions and post-approval activities.
Strong interpersonal and management skills, with a track record of effective cross-functional partnerships and team leadership.
This executive role offers an exciting opportunity for a seasoned leader to shape the future of our clinical programs and bring innovative treatments to patients. If you have a passion for driving clinical development strategy within a collaborative and mission-focused organization, we invite you to apply.
#J-18808-Ljbffr...engineered products. Our skilled team and advanced facility cater to industries requiring superior reliability. We are dedicated to... ...This is a full-time, on-site role located in Hope Hull, AL, for a Safety Manager. The Safety Manager will oversee and implement comprehensive...
**Job Overview:**Applicants must be in possession of an active armed security license for the state of TN to be eligible for this position. Unarmed or unlicensed candidates, please apply to our unarmed position for consideration.We are seeking motivated and vigilant...
...About the Job Orientation and Mobility (O&M) Specialist - School District | Kent, WA AB Staffing Solutions is seeking an experienced Orientation and Mobility (O&M) Specialist to join our team. In this role, you'll provide individualized instruction to students...
Job Title To process and stock quality merchandise on shelves and displays in a careful, clean, neat, and expedient manner. Ensuring that a variety of products is fresh and appealingly displayed for our customers while maintaining great customer service. Starting...
...Special Education Teachers for Waltham Public Schools in Waltham, MA. The open positions are in a public school for students ages grades K-12 with autism, developmental... ...teaching experience (i.e. student teaching, internships, etc.) Valid state special education...