- Leads and demonstrates ownership of the design and implementation of multiple clinical development protocols of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues.
- Oversees projectrelated education of investigators, study site personnel, and Jasper study staff.
- Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreedupon study enrollment and overall timelines for key deliverables.
- Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical
- Study reports, regulatory submissions and responses, and other program documents.
- Work collaboratively with Medical and/or Scientific Directors and Clinical Scientists working on the same or related programs.
- Serves as an inhouse clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects.
- May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Research colleagues to design and implementation of translational strategies.
- Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad crossfunctional perspectives are incorporated into Clinical
- Development Plans and protocols as appropriate.
- Stays informed of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent Jasper at key external meetings.
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
- Medical Doctor (M.D.) or nonUS equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a subspecialty fellowship is required.
- Significant experience with trial design and execution in the biotech or pharmaceutical industry.
- Clinical and/or development experience in immunology, hematology, allergy or dermatology strongly preferred.
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Senior Medical Director - Redwood City, United States - Jasper Therapeutics Defunct
Description
Jasper is a biotechnology company focused on developing new therapies to treat both chronic and life threatening diseases.Our mission is to make safer and potentially curative therapy possible for more patients in need. We are bringing together a team of high performing biotech professionals, leading academic institutions and a strong syndicate of healthcare-focused investors to achieve our vision
Position Summary:
Reporting to the Chief Medical Officer the Senior Medical Director leads the direction, planning, execution, and interpretation of clinical trials of one or more Phase 1 through 3 clinical development programs at Jasper, focused on advancing briquilimab and other novel stem and mast cell targets and molecules.
Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy.
Essential Functions/MajorResponsibilities:
Responsibilities:
Qualifications:
EDUCATION
Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
$300,000 - $330,000 a year#J-18808-Ljbffr
