Director, Clinical Operations
Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.
We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members. We take pride in hiring the best and brightest minds to our world-class company. Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture.
The Director of Clinical Operations will work closely with senior management to translate business commercial objectives into requirements for specific clinical trials and programs. This role is responsible for the successful planning, directing and execution of the clinical portfolio as well as the management, growth, and development of the clinical staff. The position requires maintenance of up-to-date knowledge of all applicable international regulation and regulatory guidance for the conduct of clinical trials in compliance with all sponsored protocols, Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), as well as in-depth product and clinical knowledge of indications. The Director of Clinical Operations will also ensure that all clinical operations is timely, efficient, and of the highest quality. Liaison with other functional departments to ensure that the highest quality is maintained. The position requires the individual to have strong leadership, problem-solving, and decision-making abilities.Essential Duties and Responsibilities:
- Strategic translation of business objectives into clinical requirements for sponsored clinical trials, publications, and meeting regulatory requirements for clinical evaluations and post-market surveillance.
- Possesses thorough knowledge of all current study protocols.
- Meets regularly with management to discuss staffing for upcoming studies and sharing of staff between departments.
- Hire, manage and develop a high performing team of CRAs, and Clinical Trial Associates. Set team’s deliverables/objectives, performance goals and empower them to deliver on the Company’s strategic priorities and objectives.
- Leads departmental meetings regularly as appropriate.
- Overall responsibility for design of dermatological related clinical trials including protocol development, clinical trial discussions, and development of timeline and budget.
- Manage the process of screening, qualifying, and selecting, and contracting with investigators, sites and vendors required for conduct of clinical trial.
- Reviews, tracks, and approves all departmental expenses associated with conduct of clinical trials.
- Works closely with Project Management and Feasibility teams in drafting timelines for studies.
- Obtains necessary clinical trial approvals from IRBs/EC’s and regulatory bodies such as the FDA, Health Canada, and Competent Authorities.
- Ensures studies are on track for site initiation, patient recruitment and enrollment, and take corrective actions where necessary to address issues.
- Directs and manages all aspects of departmental performance improvement strategies including identifying areas for improvement, developing an action plan in conjunction with all affected areas/staff, and tracking and reporting results to Senior Management.
- May travel to clinical sites for training and clinical trials monitoring purpose.
- Ensures clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.
- Develops SOPs and work instructions to assure internal files and clinical study files (patient; site; country) conform to Good Clinical Practice regulations and standards.
- Ensures adherence to protocols and compliance with regulatory (FDA/ICH/GCP) guidelines as well as SOP procedures.
- Identifies clinical training needs and develop training materials for in-house and clinical site use.
- Develops budgets for all clinical projects and adheres to company financial goals, including working with accounting for accrual expenses of clinical affairs studies.
- May perform other duties as assigned
- BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines.
- Minimum 5 years in senior clinical management position in biopharmaceutical or device industry.
- 10+ years direct experience in clinical trial management.
- Solid track record in successfully executing Phase I – III clinical trials.
- Strong, hands-on manager with experience in directing clinical affairs staff, Core Labs, and Medical Affairs Safety Reporting.
Skills, Abilities, and Other Requirements:
- Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines & FDA and applicable international regulations.
- Knowledge of electronic data capture systems and web-based clinical trial management tools.
- Meticulous attention to detail.
- Excellent interpersonal, written, verbal communication & organizational skills.
- Demonstrated ability to effectively collaborate and communicate with a variety of audiences and stakeholders including, but not limited to, Executive and Senior Management, Business Leaders, Managers, and colleagues worldwide.
- Ability to effectively manage time, manage resources and multi-task.
- Ability and willingness to both "roll up sleeves" and think strategically.
- Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
- Strong program management, financial and critical thinking skills.
- High level computer skills required (e.g. MS Word, Excel, PowerPoint).
- Ability to travel up to 30% of the time. Overnight domestic and/or international travel may be required.
- Ability to lift 10-15 pounds
Pulse Biosciences currently maintains a policy requiring all United States-based employees to be fully vaccinated against COVID-19. In accordance with applicable law, Pulse Biosciences will consider reasonable accommodations to employees who qualify as required under federal, state and local law where it is not an undue hardship to the company to do so.
Our corporate headquarters is located in Hayward, California. To learn more about us, visit our website at www.pulsebiosciences.com.
At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce. We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
LOCAL CANDIDATES ONLY
Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.