The Project Manager is critical to advancing multiple pharmaceutical development programs simultaneously, ensuring cross-functional alignment across clinical operations and clinical development. This role drives timelines, coordinates internal and external stakeholders, mitigates risks, and helps accelerate program execution from development through clinical and commercial readiness.
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
On-Site Protocol:Physical presence at the ADARx Pharmaceuticals worksite is preferred, although remote candidates will be considered for this role. The Company deems full critical engagement to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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.
