Regeneron
Healthcare
MedicalDirector,ClinicalSciences
Neural analysis suggests this role is
optimal for Director candidates.
“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
Full Job Description
Are you ready to make a meaningful impact on clinical development programs in Japan? At Regeneron, we are seeking a dedicated Medical Director, Clinical Sciences, to join our dynamic team. In this pivotal role, you will collaborate closely with the Japan Clinical Development Lead (J-CDL) to advance scientific and clinical aspects of our programs. From contributing to global clinical teams to supporting regulatory filings, your expertise will drive innovation and deliver results that matter. Join us in shaping the future of clinical development, where your skills and insights will play a vital role in transforming lives. **A Typical Day:** As the Medical Director, Clinical Sciences, your day will be filled with impactful activities, such as: * Supporting the clinical components of assigned clinical development programs (CDPs) in Japan. * Providing clinical and scientific input for regulatory documents, including J-NDA/J-CTD submissions. * Contributing to the development and adaptation of clinical trial protocols and related documentation for Japan-specific needs. * Collaborating with cross-functional teams to ensure clinical feasibility and address local medical needs in global studies. * Participating in investigator meetings, site initiation visits, and vendor kick-off meetings to drive study execution. * Offering medical/scientific input to resolve issues during study conduct and execution. * Staying current on scientific advancements in therapeutic areas and representing the company at national and international conferences. * Building and maintaining relationships with key opinion leaders (KOLs) and investigator sites. **This Role May Be For You If:** * You have a strong understanding of the drug development process, clinical trial design, and good clinical practice (GCP). * You excel in both Japanese and English, with business-level proficiency in English communication. * You enjoy collaborating across cross-functional teams, bringing diplomacy and influence to
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