Project Manager
Responsibilities
- Develop and maintain clinical, nonclinical, and/or CMC timelines and project plans using inputs from the responsible subject matter experts from each function
- Support Clinical Project Team Leads as needed with action item follow up, meeting minute publications, and other tasks pursuant to project / program deliverables
- Manage external CROs via routine teleconferences and written correspondence to ensure that project deliverables are on time and within budget
- Keep internal stakeholders appraised of project status and advise of risks to project timeline and actions needed to mitigate identified risks
- QC and/or contribute to various reports, data, data tables, presentations, and/or documents for regulatory submissions (e.g., IND, IB) using advanced functions of MS Word, Excel and e-sub compliance software, as appropriate
Requirements / Qualifications
- BS or MS in Toxicology, Bioanalysis or related field of study with 1-4+ years or relevant experience in the pharmaceutical industry
- PMP certification is preferred
- Must be highly organized, detail oriented, with the ability to multi-task and be flexible and adaptive in a fast-paced environment
- Excellent oral and written communication
- Familiarity with MS Project, Smartsheet or other timeline / resource management tool
- Hands-on experience in a GxP or regulated environment
- Demonstrated understanding of various ICH guidance documents
- Ability to travel on occasion for vendor audits, conferences, etc.
Required Key Attributes
- Must be able to work independently with supervision as needed
- Must be collaborative, work well with other Clinical Development team members in a matrix team environment
- Excellent written and verbal communication skills are essential for this role
- Strong organizational skills with attention to detail and accuracy
- Ability to maintain a high level of confidentiality and exercise discretion
- Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges
Benefits
ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
Pay
N/A
Schedule
N/A
Skills
Must be able to work independently with supervision as needed. Must be collaborative, work well with other Clinical Development team members in a matrix team environment. Excellent written and verbal communication skills are essential for this role. Strong organizational skills with attention to detail and accuracy. Ability to maintain a high level of confidentiality and exercise discretion. Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges.
Company Overview
ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a late-clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system.