Director/Senior Director, Clinical Science
Our client is a private, clinical-stage company. They have asked us to assist them in a search for a Director/Senior Director, Clinical Science.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Responsible for the study design, execution strategy, and CRO oversight, including managing study budgets and timelines.
- Accountable for protocol development, protocol amendments, informed consent forms, and clinical sections of annual reports and regulatory submission documents.
- Presents complex aspects of protocol design at investigator and internal meetings.
- Manages interim reporting requirements to DSMB's and funding partners.
- Leads the development of outsourcing strategies and the development of clinical trial budgets.
- Ensures that all studies are carried out according to the study protocol, SOPs, and applicable GCP/ICH guidelines.
- Analyzes scientific study results, evaluates, and interprets data, recognizes, and reports safety and efficacy data trends.
- Identifies and resolves problems, conflicts, and obstacles to the success of projects.
- Provides project updates, recommendations, and risk analysis/contingency plans to company leadership.
- Leads clinical operations process improvement initiatives to address clinical needs.
- Ensures inspection readiness at all times.
- Responsible for management and leadership including recruitment, training, mentoring, and work assignments.
- Responsible for performance management, coaching, and development of staff.
- Supports staff career development and assesses training requirements of assigned employees and contractors.
- A Bachelor’s degree is required. An advanced degree in a science-related filed is strongly preferred.
- Must have at least ten years (BS) or at least seven years of experience (advanced degree) in clinical research, including clinical trial design, execution, and data analysis.
- Must have experience in Phases I-III, including a lead role in large global trials.
- Infectious disease experience is preferred.
- Must be familiar with data management, biostatistics, and data analysis, as well as electronic data capture tools and 21CFR11 requirements.
- Excellent knowledge of ICH/GCP guidelines is required.
- Must have strong medical/scientific writing skills.
- Requires experience authoring clinical sections of regulatory documents.
- Must have strong leadership, project management, and process improvement acumen.
- Excellent interpersonal communications, organizational, and presentation skills are required.
- Requires demonstrated teamwork skills, including cooperation, willingness to learn from others, and the ability to share relevant information.
- Superior negotiation and influencing skills are required.
- Must have experience anticipating and addressing key technical and operational problems in clinical research that could impact the broader process or team.
- Must be proficient and have the ability to utilize software applications that support Clinical Operations.
- Up to 10% travel may be required.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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