We are looking for an individual to partner with a our key client to provide operational and strategic program management leadership for one of more programs. This position will also be instrumental in later stage clinical development and could continue to support the program through product licensure.
The ideal candidate would effectively and efficiently execute on the program(s), successful interactions to occur with Research, Finance, QA, Technical Development, Regulatory, Clinical Development, CMC etc.
location: Holly Springs, North Carolina
job type: Contract
salary: $55 - 65 per hour
work hours: 9 to 5
- Considerable experience in Project/Program Management (PM) related early drug development with exposure to translational development experience, preferably in cell or gene therapy
- Demonstrated experience in the execution of programs for drug candidates from preclinical development through IND with experience in product development relative to Clin-Reg strategy
- Knowledge of drug development processes and industry best practices, including clinical and non-clinical study design and execution
- Highly organized, proactive, results-driven; Proactively developing solutions and maximising opportunities ahead of time that have been well thought out and vetted
- Strategic with ability to see the "big picture" and identify developing issues; Ability to make strategic decisions; therefore, requiring to see the big picture and think cross-functionally when making decisions with limited guidance
- Ability to be effective in both the strategic and tactical aspects of product development
- Strong critical thinking skills with objective interpretation of scientific and commercial data
- Very strong interpersonal skills with ability to bridge between scientific and non-scientific team members, develop and manage relationships in a matrixed environment including with third parties
- Strong team player with ability to manage subordinates or mentor others
- Strong negotiation skills with ability to persuade others and understand the position of others
- Strong verbal communication skills (English) including public presentation; strong written communication skills (English) in both narrative and abbreviated formats
- Strong computer skills including Word, Excel and PowerPoint essential; familiarity with software used for PM tracking tools
- Masters or Doctoral degree in life-sciences, medical-related sciences or chemical or biomedical engineering with specialization in PM a plus. Experience equivalent to a graduate degree may also be acceptable.
- 5+ years of relevant post-undergraduate work or academic experience
- 5+ years of directly relevant PM experience in the pharmaceutical industry, preferably in early development of vaccines or other biologics (gene / cell therapy).
skills: Project Management, Clinical research, Clinical Study Design
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.