The Director, of Clinical Development is responsible for leading a clin
Other Jobs You May Be Interested In
- Manager, APAC Trade Compliance (Remote)
- Corporate Accounts Manager, OEM – United States – Remote
- PIP Claims Representative II – Florida
- Bristol West APD Appraiser – Virtual/Hybrid
- Regional Sales Director – APD – Danielson
- Senior APD Process Management Consultant (Remote)
- Principal Scientist, Pharmacology
- Scientist, Downstream Process Development
- Senior or Executive Medical Director
- Technical Consultant I
- Salesforce Business Analyst
- Sales Account Executive
- Debit Card Support Specialist/ Debit Card Disputes Clerk – Remote
- Online and Card Specialist
- Customer Service for Healthcare Card Support
- Open Text (Micro Focus) OPTIC Application Administrator (Remote in the US)
- Business Process Solutions Analyst (Remote)
- Senior Manager Data Architecture (US Remote)
- Manager Consulting Payroll (US Remote)
- Backend Engineer, RDP
- SAP RDP Consultant
- Senior Manager, Technical Operations
- RWE Epidemiology Contractor
- Client Solutions Software Engineer
- Strategic Account Executive
- Chief Financial Officer
- Regional Account Manager Amazon
- Remote Shuttle Driver (DFW Airport)
- Call Center Officer – Remote Work
- Online Call Center Manager
- QC Inspector – The Toro Company
- Access and Reimbursement Manager New York City (Remote)
- HEAD OF COLLEGE SCOUTING – PHILADELPHIA
- LMS SPECIALIST (REMOTE / HOME BASED)
- Specialty Sales Consultant (Remote)
- CDL-B Team Driver Jobs in ArcBest II: Panther in Georgetown, DE (job id : 1676354598)
- Business Development Representative – MMB
- VLSI Backend Engineer
- Facebook Data Entry Remote Jobs – Apply Now
- Netflix At Home Careers – Data Entry Remote Jobs (Part-Time) $30/H
- Netflix Data Entry Jobs – No Experience
The individual may be called upon to represent the clinical sciences team on the global program team which provides cross-functional strategic leadership for the manufacturing, development, approval and commercialization of the program. The individual must have strong team leadership skills and have deep knowledge of the clinical drug development process, spanning early/translational phases through to registration.
Primary Responsibilities Include
- Functioning as the clinical sciences team leader to create and execute an clinical development plan that provides strategic priorities and solutions to program challenges.
- Partner with cross-functional leaders and governance bodies to provide leadership and direction to support the clinical development plan and drive cross-functional decision making.
- If needed represent the CST on the global program team
- Establish and maintain positive relationships with clinical trial investigators/physicians, KOL’s and clinical advisors through independent collaborations and scientific meetings.
- Provide expertise and leadership to support protocol development, regulatory agency engagements, and documents including INDs and BLAs.
- Supports key business initiatives including providing strategic input on compounds in development and assessment of their development strategies
Desired Education And Skills
- MD and/or PhD required, subspecialty training in neurology or gene therapy is preferred.
- 3-5 years of hands on pharmaceutical or biotech experience in clinical development; Rare/orphan diseases preferred, but not required.
- Prior IND/CTA and/or NDA/MAA filing experience.
- In depth knowledge of drug development process and oversight of clinical trials.
- Working knowledge of biostatistics, regulatory, clinical pharmacology and pharmacokinetics.
- Excellent interpersonal, written, verbal and visual communication skills.
- Proven ability to successfully manage multiple tasks and prioritize accordingly.
- Proven ability to interact cross-functionally with strong presentation skills.
- Willingness to travel.
- Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion.
