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Director, Clinical Development

DirectorDirectorFull TimeRemoteTeam 11-50Since 2017H1B No SponsorCompany Site LinkedIn

Location

California

Posted

44 days ago

Salary

$181.7K - $317.9K / year

Postgraduate Degree3 yrs expEnglishGoogle Cloud Platform

Job Description

• Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution • Serve as Medical Monitor for assigned clinical trials • Support/manage preparation of materials for trial-related clinical committees • Contribute to planning, authoring, and critical review of documents submitted to regulatory authorities • Contribute to the strategic planning, authoring, and critical review of scientific data disclosures • Develop professional relationships with external clinical opinion leaders, investigators, and consultants • Contribute to engagement with external stakeholders • Function as an independent member of the team and represent clinical development at internal cross-functional or external meetings • Other duties related to clinical development as assigned

Job Requirements

Board Certified MD or MD/PhD or equivalent qualification with relevant medical experience
Experience in hepatology, MASH or internal medicine preferred
Minimum of 3 years of relevant experience in clinical development in the biotech and/or pharmaceutical industry; five (5) years preferred
Direct experience in executing Phase III clinical trials, including medical monitoring responsibilities
Solid knowledge of GCP, ICH guidelines and FDA/EMA/CHMP regulations
Proven experience authoring or overseeing regulatory documents
Strong interpersonal and communication skills
Skilled at searching, critically evaluating, interpreting and synthesizing scientific literature and clinical trial data
Demonstrated problem-solving ability and ownership of issues
Comfortable working independently and as part of cross-functional teams
Highly organized with strong prioritization and time-management skills
Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint)
Experience with preparation of documentation for BLA/NDA/MAA submissions desirable
Knowledge of the regulatory path across the various health authorities (FDA, EMA etc) desirable
Experience in Hepatology, Gastrointestinal, Endocrinology or related field, preferred.

Benefits

medical, dental and vision coverage
life insurance
disability insurance
401(k) savings plan
flexible spending accounts
employee assistance program
tuition reimbursement program
voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance
time off pursuant to its sick time policy
flexible vacation policy
parental leave policy