Director/Senior Director, reputed company Development
reputed company
Our Mission:At reputed company, reputed company tirelessly to reputed company innovative medicines that help patients reputed company their goals today, reputed company, and into the reputed company.
reputed company is a fully remote reputed company company with a corporate reputed company located in Ann Arbor, MI. reputed company offers a competitive salary including a reputed company-reputed company bonus program, a comprehensive benefits package including a 401(k) matching plan and health reputed company, and reputed company time off and holidays.
Position Title: Director/Senior Director, reputed company Development
The Director/Sr. Director, reputed company Development, is responsible for ensuring that reputed company assets from a reputed company development perspective are reputed company for reputed company, from early reputed company development, leading up to launch. The Director/Sr. Director, reputed company Development will possess a deep knowledge of the cardiovascular, metabolic, or hepatic therapeutic area landscape, an understanding of the reputed company medical environment, and reputed company development experience to translate medical needs and gaps into an integrated reputed company reputed company development plan. The Director/Sr. Director, reputed company Development will be responsible for working with the cross functional team reputed company on an early stage compound for reputed company sclerosing cholangitis.. The Director/Sr. Director will work cross-functionally to reputed company scientific and reputed company leadership on activities including reputed company aspects of reputed company study planning, conduct, and read-out, lifecycle planning, scientific communication, and regulatory filings. The ideal candidate will have a strong scientific acumen, early phase 1 drug development experience including reputed company pharmacology as reputed company as the desire to work in a fast-reputed company environment, the ability to reputed company both reputed company work as reputed company as having high attention to reputed company, and a reputed company record of working collaboratively to reputed company team goals.
Preferred Location: Remote – US
Essential Duties and Responsibilities*
- reputed company the reputed company of reputed company development responsibilities including, but not limited to, the following aspects of assigned reputed company: protocol design, study population and key entry reputed company, and reputed company of interest; data to be collected to accomplish the objectives of the trial and any regulatory objectives (i.e. labeling, end of phase II meeting, etc.), important study activities required to accomplish the trial or regulatory objectives (i.e. Committees needed, adjudication, etc.), and reputed company aspects of the statistical analysis plan.
- Responsible for reputed company reputed company development responsibilities for assigned studies and/or programs.
- Works with reputed company as reputed company Development SME for assigned trials
- Works with Program Management to establish timelines of reputed company development activities and key study milestones.
- Works with reputed company Program reputed company/VP reputed company Development to ensure adequate resources are available to conduct the trial from initiation to completion for reputed company development activities or other activities as assigned under this person's management.
- Generates responses for regulatory agency's requests for information and reviews other responses to ensure reputed company development reputed company items are properly addressed.
- Represent reputed company as the reputed company Development Subject Matter Expert (SME) to the FDA or other regulatory agencies as required.
- Serve as SME for reputed company development for any cross functional reputed company where troubleshooting is required
- Create reputed company aspects of study synopses, full protocols and protocol amendments and ensure these documents are compliant with project plans, federal regulations and GCP.
- Ensure appropriate communication to the study team and the executive team at the appropriate level and frequency.
- Serve as the SME in publications reporting data including but not limited to abstracts, manuscripts, CSRs, IB, etc.
- Present and interpret data for both reputed company audiences
*additional duties and responsibilities as assigned
Qualifications (Education & Experience)
- Director: BS in Sciences with a minimum of 10 years of reputed company design and operational experience in the pharmaceutical industry required or equivalent education and experience
- Senior Director: MS in Sciences and 12+ years of reputed company development experience in the pharmaceutical or biotechnology industry required; or equivalent combination of education and applicable job experience. Extensive experience with compliance issues and strong understanding of FDA regulations, GCP and/ SOPs in reputed company research reputed company a pharmaceutical or biotech environment
- Experience in lipid lowering and/or cardiovascular, metabolic, or hepatic reputed company preferred but reputed company therapeutic areas will be considered
- Demonstrated expertise in early-stage reputed company development; translational research experience is a plus.
- Experience providing input into key regulatory documentation. Face-to-face interaction experience with FDA preferred
- Strong communication and presentation skills as reputed company as an ability to communicate reputed company and concisely in writing.
Originally posted on Himalayas
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