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Project Manager/Director
Project Manager/Director Job Description Cybrexa Therapeutics is seeking an experienced, collaborative, and dynamic Project Manager/Director to lead and develop project management for the company’s preclinical and clinical and business operations. Essential Job Functions and Duties: Proactively works with stakeholders to define and implement projects/initiatives for both scientific and business operations projects (e.g., business development, due …
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Project Manager/Director
Project Manager/Director Job Description
Cybrexa Therapeutics is seeking an experienced, collaborative, and dynamic Project Manager/Director to lead and develop project management for the company’s preclinical and clinical and business operations.
Essential Job Functions and Duties:
- Proactively works with stakeholders to define and implement projects/initiatives for both scientific and business operations projects (e.g., business development, due diligence)
- Creates integrated project plans for preclinical and clinical programs, including CMC. Working with a cross-functional team, implements and monitors progress against project plans and revises as necessary
- Accountable for developing the operational strategy and managing the timelines, budgets, and quality across programs. This includes:
- Execution of the sourcing/vendor strategy
- Understanding and planning how different studies fit together (e.g. how the readout from a study informs the next steps and overall program strategy)
- Proactively engages in both quality assurance and risk management activities to ensure that project deliverables are met according to requirements
- Responsible for timely issue escalation to appropriate stakeholder(s)
- Accountable for building, forecasting and managing the program budget
- Manages, facilitates, and documents key team meetings (e.g., meeting agendas & minutes, action logs and decision logs) and facilitates effective decision making
Knowledge, Skills and Abilities:
- 5+ years of Project Management experience in Pharma and/or Biotech
- Thorough understanding of the processes associated with project and study management
- Experience across preclinical and clinical project management
- Experience in business operations project management preferred, but not required
- Extensive experience with clinical trial conduct, US/global clinical trial operations
- Experience with project managing regulatory filings (e.g., FDA)
- Ability to work effectively across functions
- Knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations
- Collaborative communication skills, self-motivated, and capable of balancing multiple workstreams
- Strong Microsoft Office acumen: e.g., MS Project, Power Point, and Excel
- PMP certification preferred
Education/Experience
- The candidate should have at least a BA/BS degree with 5+ years of industry experience in pharma/biotech project management, with demonstrated strong contributions to projects
- PhD in a scientific discipline is preferred
- Previous experience in working in project management for preclinical programs and clinical programs
Scientist, Biology and Analytical Chemistry
We are seeking an Analytical Chemist for Small Molecule Assay Development and Analysis. Essential Job Functions and Duties The successful candidate will develop HPLC and mass spectrometry assays, analyze samples and interpret results for analytical development and characterization of small molecule, some containing protein and other excipients, to support the profiling of new drug and …
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Scientist, Biology and Analytical Chemistry
We are seeking an Analytical Chemist for Small Molecule Assay Development and Analysis.
Essential Job Functions and Duties
The successful candidate will develop HPLC and mass spectrometry assays, analyze samples and interpret results for analytical development and characterization of small molecule, some containing protein and other excipients, to support the profiling of new drug and early stage formulation development activities. In addition, the candidate’s ability to perform and work with pharmacology scientists will be beneficial. The Candidate should have extensive experience the design of pre-clinical studies. The Candidate responsibilities will include the following work:
Knowledge, Skills and Abilities
- Establish protocols for in vitro experiments, collaborate with colleagues and perform analytical testing of candidate compounds
- Apply scientific expertise and drug discovery experience to impact existing and future new drug candidate identification
- Maintain a ‘cutting edge’ awareness of technical developments and scientific knowledge.
- Conduct studies to increase confidence in rationale for new approaches, and hence support new idea generation and clinical proof of concept studies.
- Provide in vitro experimental support
- Ability to perform/assist in in vivo pharmacology experiments would be preferred but not required
- Prepare written reports and present scientific data at appropriate scientific meetings (internal and external).
Education/Experience
The candidate should have at least a BS/MS degree in biology with at least 2 years of experience of industry experience in biological sciences or biochemistry, with demonstrated scientific excellence. Previous experience in working on drug discovery programs to develop compounds from the pre-clinical to the clinical setting would be preferred but not required.