Regeneron
Healthcare
MedicalDirector,ClinicalSciences
“Medical Director, Clinical Sciences at Regeneron. Skills: Clinical development, Regulatory filings, Protocol design. Support clinical components of programs. Provide clinical input for regulatory documents”
What You'll Achieve.
Advance scientific aspects of programs; Advance clinical aspects of programs; Support regulatory filings; Drive innovation; Deliver results
Industry & Context.
Problem-solving skills; Analytical skills
What They're Looking For.
Must Have
MD or MD/PhD, 5+ years pharmaceutical industry experience, 3+ years clinical development experience, Expertise in regulatory filings, Expertise in clinical document preparation, Proven ability in protocol design, Proven ability in clinical data review, Familiarity with medical monitoring, Knowledge of Phase I-III trials
Nice to Have
Experience with clinical feasibility assessments, Experience with Japan-specific enrollment
What You'll Do.
Support clinical components of programs
Provide clinical input for regulatory documents
Provide scientific input for regulatory documents
Contribute to protocol development
Adapt protocols for Japan-specific needs
Collaborate with cross-functional teams
Ensure clinical feasibility
Address local medical needs
Participate in investigator meetings
Participate in site initiation visits
Participate in vendor kick-off meetings
Offer medical input to resolve issues
Offer scientific input to resolve issues
Stay current on scientific advancements
Represent company at conferences
Build relationships with KOLs
Maintain relationships with KOLs
Build relationships with investigator sites
Maintain relationships with investigator sites
How You'll Work.
Team & Collaboration
Cross-functional teams; Global clinical teams; Investigator sites; Vendor teams
Communication Scope
English communication; Japanese communication
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