Director, Clinical Affairs

Pulse Biosciences (Nasdaq: PLSE) is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company's proprietary CellFX nsPFA technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The Company is actively pursuing the development of its CellFX nsPFA technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit pulsebiosciences.com to learn more.

At Pulse, we:

• Exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.
• Take pride in hiring the best and brightest minds to our world-class company.
• Are individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude that will excel in our culture.

About the Role

As the Director of Clinical Affairs, you will work closely with senior management to translate business commercial objectives into requirements for specific clinical trials and programs. You will be responsible for the successful planning, directing and execution of the CellFX nsPFA Cardiac Ablation clinical portfolio. The position requires maintenance of up-to-date knowledge of all applicable US, 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. In this role, you will bring strong leadership, problem-solving, and decision-making abilities.

You will make an impact by:

• Providing operational expertise and strategic input into the planning, implementation, and execution of the clinical trials for the Cardiac Ablation portfolio in accordance with project timelines, budget, and quality standards.
• Contributing to the design of clinical trials including protocol development, case report forms, management of trial master files, and development of timelines, milestones, project plans/deliverables in conjunction with the clinical research team.
• Managing the process of screening, qualifying, and selecting, and contracting with investigators, sites and vendors required for the conduct of clinical trials.
• Supporting training of internal staff, study investigators and other site personnel on the proper conduct of the trial and the review of specific product performance specifications.
• Ensuring procedures and techniques are being properly performed by investigators, site personnel, and the field team members or Contract Research Organization (CRO) to mitigate risks associated with study devices.
• Attending surgical cases for data collection, as needed.
• Ensuring studies are on track for site initiation, patient recruitment and enrollment, and taking corrective actions where necessary to address issues.
• Problem solving and defining a solution matrix for all clinical study issues as they arise.
• Managing clinical research reporting, such as reporting to regulatory authorities and clinical research oversight entities (IRB/Ethics) as necessary.
• Supporting Regulatory Affairs during the submission process.
• Ensuring clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.
• Reviewing, tracking, and approving clinical trial expenses; submitting monthly clinical trial accruals to accounting.
• Building relationships and trust with key stakeholders of the company both internally and externally.
• Developing and managing budgets for all clinical projects and adheres to company financial goals, including working with accounting for accrual expenses of clinical affairs studies.
• Hiring, managing and developing Clinical Affairs internal team and contractors, as needed. Setting objectives, performance goals and empowering them to deliver on the Company's strategic priorities.
• May perform other duties as assigned.

To be successful, you will bring:

• BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines.
• 10+ years of progressive industry experience in a medical device company (preferably in Cardiology).
• 5+ years clinical trial management experience with class II and class III medical devices.
• Experience in IDE clinical trials, PMA and MEDDEV submissions and working with an early start up company is a plus.
• Strong hands-on experience in directing and managing CROs, Core Labs, and Safety Committees (e.g., DSMB and CEC).
• Management experience building and leading a team is a plus.
• Demonstrated ability to function as both a project leader and a project team member.
• Proficient knowledge of medical terminology including cardiovascular medical device and cardiovascular pathophysiology.
• 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.

You'll experience:

• Purposeful and rewarding work collaborating with bright and curious minds!

• Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!
• A variety of health insurance plans and supplemental insurance options.
• 401k retirement savings plan.
• Stock options awards and ESPP program.
• Paid time off, paid holidays, and flexible work schedule.
• Wellness program with free onsite gym, mindfulness classes and activities.
• A commitment to providing a respectful work environment to our diverse workforce.

Pay Range:

Compensation is determined based on a wide range of factors including job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $175K - $220K

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.

To learn more about us, visit our website at www.pulsebiosciences.com.

LOCAL CANDIDATES ONLY

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.