Join other like-minded innovators and
out-of-the-box thinkers in our pursuit of
meaningful change in nerve repair
Tulavi Therapeutics is made up of a wonderfully diverse team of smart, talented, and passionate people who believe that we can discover, design, develop, and deliver nerve repair solutions that will help physicians to confidently provide better outcomes. We believe that we can step alongside both industry shaping experts and those who want to improve their capabilities to provide intuitive solutions that not only treat nerve problems, but provide proactive solutions that help to eliminate issues before they happen. This work is not just something that we do, but something that we truly believe can transform people's lives. It is why we are excited about what we are doing today and where we'll go moving forward!
We are looking for people who are interested in what we are doing, who can jump right in to contribute, and who want to be part of our team. We have fun, we work hard, and we are searching for people who can add to our efforts. We believe that it is equally important to be as excited about the team you work with as it is the work that you are doing!
If you find the idea of joining a dynamic team that's dedicated to improving the lives of patients requiring nerve care, we invite you to review our available opportunities.
Full-time Manufacturing Engineer II
Full-time Senior Director/Director, Quality Assurance
Full-time
Full-time
VP, Regulatory & Clinical Affairs
Tulavi Therapeutics, Inc. is currently recruiting for a VP, Regulatory & Clinical Affairs executive for our early-stage medical device/drug combination start-up company developing new technologies to improve outcomes in nerve repair. Through developing simple, intuitive solutions to help to restore nerve function and reduce chronic pain we will not only advance nerve repair but make it more accessible and outcomes more predictable.
Currently, Tulavi is seeking an accomplished VP, Regulatory & Clinical Affairs who is passionate about improving healthcare outcomes in patients with nerve injury. The ideal candidate will be a key member of the executive team, responsible for providing strategic and operational leadership for the planning, management, execution, and support of Regulatory and Clinical activities for the organization.
We enjoy working collaboratively with our team, our partners, and clinicians. We are focused on developing a smart, high performing team that includes people from a wide variety of backgrounds and experiences. We are committed to building an open, diverse, and inclusive culture for all employees.
Responsibilities:
We are recruiting for a Vice President of Regulatory & Clinical Affairs to take over the leadership for the regulatory and clinical strategy and operations for Tulavi’s products across the Company’s medical device and drug-device combination products. This is an opportunity for an experienced regulatory and clinical executive to get involved at the formative stage of a company and play the central role in shaping all regulatory and clinical activities at the company
In addition to the strategic leadership, the Vice President will initially be responsible for the operational implementation of regulatory and clinical activities, including authoring regulatory submissions and the documentation and reporting requirements of the clinical development program. The VP will work closely with the CEO and other key functions both internally and externally to ensure successful completion of all regulatory and activities.
- Lead the regulatory and clinical strategy for the company’s medical device and combination drug-device products, including the approach and timing of regulatory submissions
- Responsible for the design and implementation of evidence generation plans for the Company’s products with support and input from R&D, Marketing, Sales.
- Author regulatory submissions and clinical study design for company’s product portfolio, ensuring scientific accuracy.
- Responsible for the selection and engagement of clinical trial investigators and sites.
- Support company in building a network of clinical advisors and KOLs to provide guidance on product design, development, and implementation.
- Responsible for the selection and engagement of clinical research organization.
- Hire and oversee Director of Clinical Operations to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA guidelines as well as company policies, processes, and procedures.
- Clinical trial design including specific attention to patient population, Investigator Brochure, statistical analysis plan, inclusion/exclusion criteria and case report form design in a clinical area where few well-designed studies exist.
- Responsible for providing accurate, current reports to executive team and the Board of Directors on the status of clinical trials.
- · Deploy resources, as necessary, for each new project ensuring that clinical program and trial objectives have been properly communicated to key personnel.
- Lead responses to audits (site, internal file and process, and regulatory agencies).
- Assure operational oversight and quality of all regulatory and clinical activities.
- Provide regulatory and clinical perspective to product development and preclinical data collection activities at the company.
Requirements:
- Education: Higher educational degree strongly preferred, such as Master’s, PhD, or MD; minimum of 10 years of experience in regulatory strategy and implementation and/or clinical development for a medical device or combination drug/device product.
- Authored FDA 510(k), de novo and/or PMA submissions for medical devices and/or drug-device combination products regulated through CDRH or CDER; experience leading interactions with FDA on regulatory submissions.
- Experience designing and overseeing open-label and randomized controlled trials (single, double blind).
- Experience with using validated patient reported outcome assessments (PROMs) to assess patient safety and efficacy.
- Experience working directly with clinical investigators and clinical advisors to design clinical trial.
- Experience building a network of external clinical experts in an advisory board or consulting engagement/capacity.
- Strong writing skills with attention to detail.
- Ability to communicate and establish credibility at all levels of the organization including with the Board of Directors, investors, and other third parties.
Characteristics:
- Strategic thinker, agility thinking through the benefit-risk determinations both for individual products as well as how they relate to overall product portfolio
- Self-starter mentality, with a drive to bring excellent quality to this role and play a key role in bringing a new first-in-class technology to the market
- Ability to quickly get up to speed in a clinical area and take deep technical dives on preclinical and clinical data for discussion with Clinical/R&D team.
- Leverage understanding of clinical practice to better design clinical trials.
- Appreciation of where each product fit within the overall healthcare economics, to address unmet needs across the patient, physician hospital/ASC, and payers.
- Thought leadership in the clinical field and a track record of being able to develop and manage relationships with key opinion leaders.
- Strong project management skills reflected in experience building clinical strategy, translating that to clinical trial execution, and regulatory submission.
Bonus Experience:
- Authoring CDER/CDRH submissions for drug-device combination products.
- Partnering with data science/data management teams on data collection strategy and product design.
- Experience with running trials with pain as a primary or secondary endpoint (VAS or other assessments)
- Experience designing and overseeing the creation of cellphone-based apps for capturing patient-reported outcomes
- Strong written skills to participate in and/or lead preclinical study report review and generation
- Experience with Breakthrough technologies a plus
Candidate must be prepared for some travel to clinical investigator sites, as needed. Candidate must be vaccinated. Candidate must be willing to relocate to Bay Area to be primarily in-office in Los Gatos, CA.
Full-time
Full-time