Clinical Project Manager managing Class II and Class III medical device clinical trials for Cochlear. Leading teams and ensuring compliance with regulatory standards in a hybrid work environment.
About the role
- Senior Principal Scientist leading global clinical operations and strategic initiatives for biopharmaceutical programs. Overseeing complex clinical studies and ensuring quality and efficiency in development activities.
Responsibilities
- Provides expert strategic, scientific, and operational leadership in the planning and execution of highly complex program(s)
- Lead and direct global, cross-functional teams in end-to-end clinical development activities
- Overarching responsibility and oversight of clinical program execution
- Ensure consistency and quality across assigned portfolio
- Assist the Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations
- May lead operational components of mergers and acquisitions
Requirements
- 15 years of experience with a Bachelor’s degree OR 12 years with a Master’s OR 8 years with a PhD/PharmD
- Experience managing direct reports
- Experience in conducting autoimmune and/or immune mediated diseases in gastroenterologic, rheumatologic and dermatologic diseases including but not limited to ulcerative colitis, rheumatoid arthritis, psoriasis, atopic dermatitis, etc.
- Conducted global phase I-V trials
- Experience in regulatory filings (e.g. Agency responses, filing documents [e.g. clinical summary, clinical efficacy, clinical safety, etc.])
- Experience with CoPilot, MS Forms, and Power Automate is highly preferred.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days
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