Sr. Director Clinical Operations
3 weeks ago
Job type: Full-time
Hiring from: USA Only
Category: Medical / Health
At DermTech, we believe there's a better way to treat your skin, and we're using technology, innovation, and data to fundamentally change the way the world practices dermatology. We have developed technology that assesses your skin at the RNA and DNA level, so we can see signs of skin cancer far earlier, reduce the need for surgery, enable optimized treatment plans, and customize skincare plans to your skin's unique molecular makeup. We call this practice “precision dermatology” and we believe it truly is a new era in disease detection. A method that is not just better, but different. One centered around our patented smart sticker, which collects tissue from your skin's surface easily, accurately, and painlessly, and our state-of-the-art Gene Lab, which analyzes that tissue at the genomic level using a proprietary gene analysis system. By pushing the boundaries of areas like cancer detection and patient care, we truly believe our technology can change the world. And we're seeking team members with the vision, passion, and creativity to do the same.
The Senior Director Clinical Operations will work closely with the VP Clinical Operations and Research Collaborations and will provide strategic input to clinical trial design and protocol development. In addition, this person will be responsible for overall program management of DermTech's clinical trials in the spirt of ICH-GCP regulations as required to support regulatory authority submissions.
Primary Duties and Responsibilities:
- Direct and oversee the operation of the clinical program(s) to ensure compliance with regulatory requirements.
- Ensure adequacy of data acquisition and management, and timely completion of studies and associated projects.
- Identify and communicate project objectives, propose innovative solutions to potential obstacles in study conduct, study sites, or with CROs.
- Ensure adequate study resources are in place to successfully complete clinical project and programs on-time and, on-budget.
- Evaluate CROs for their ability to execute clinical trial work, compare budgets and timelines and make recommendations to senior management.
- Coordinate with departmental teams to ensure appropriate fiscal oversight, including management of vendor scopes-of-work and change orders.
- Oversees the operational aspects for the development and delivery of standard study protocols, informed consents, vendor selection/management and site selection and recruitment strategies.
- Oversee vendor and site qualification activities in conjunction with Clinical Quality Assurance, Manufacturing and Tech operations.
- Oversee management and maintenance of Trial Master File.
- Support regulatory audits and inspections.
- Provide guidance on all clinical operation logistics associated with execution of clinical studies (including clinical supplies, sample shipments etc.).
- Contribute to the development of SOPs and other procedural documents.
- Interact with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, R&D, Clinical Supply (Investigational Product) and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities.
- Develop and provide input on the development of CRF and CRF completion guidelines.
- Participate in data cleaning, listing, and report output reviews.
- Develop, review, and approve study-relate, plans, specifications, instructions for use, charters, newsletters, and materials.
- Participate in protocol deviation listing reviews and meetings.
- Develop presentations for clinical sites, team and investigator meetings.
- Bachelor's degree in a nursing or related life science field required; Master's degree preferred.
- 12-15 years' previous clinical work experience.
- Experience utilizing CTMS, EDC, TMS and related software.
- Prior experience in management and monitoring of CRO and investigative sites.
- Broad knowledge of ICH, GCP, IRB/IEC, and local regulatory authority for diagnostic & assay development regulations.
- Superior organization skills with excellent attention to detail.
- Strong written and verbal communication skills.
- Excellent computer skills and knowledge of Microsoft Office and the ability to learn appropriate software
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition at jobs at dermtech.com
DermTech is not accepting unsolicited assistance from search firms for this employment opportunity.
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This job has a geo-restriction in place: USA Only.
Please mention that you come from Remotive when applying for this job.
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