96 Director/Sr. Director, Clinical Development/Clinical Affairs Jobs in San Diego, CA
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Director/Sr. Director, Clinical Development/Clinical Affairs
$147k-186k (estimate)
Full Time
2 Months Ago
Truvian is Hiring a Director/Sr. Director, Clinical Development/Clinical Affairs Near San Diego, CA
ABOUTWant to work for a fast-paced and disruptive company that is working to revolutionize blood testing? Truvian is a healthcare company at the intersection of diagnostics and consumer tech. We are developing an automated benchtop diagnostic system to provide lab-accurate results in 20 minutes for a comprehensive suite of health tests. Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from one small blood sample in minutes in a retail setting or private clinic.Our work at Truvian is more than a job—it’s a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to putting health information where it belongs—in the hands of the individual. We are partners in the belief that talented people working as a team can make every day an adventure. Join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today’s connected consumers!JOB SUMMARY Truvian is looking for a Director/Sr. Director, Clinical Development/Clinical Affairs, as we enter our next evolution phase. In this role, you will develop the strategic plan for clinical development studies and clinical trials to achieve specific study objectives in alignment with business goals. This is also a hands-on position where you will oversee all stages of clinical study execution, from initial planning to study completion, in compliance with applicable regulatory standards and Good Clinical Practice (GCP). You will work with an interdisciplinary team of internal and external stakeholders, including regulatory, product development, marketing, and scientific affairs, to ensure the studies are designed appropriately and will deliver high-quality data to support evidence-based product claims. This role will report to the Sr. Director of Clinical Development and Scientific Affairs (CDSA).HERE’S WHY YOU’LL LOVE THIS JOB:
- You will be setting the strategy and managing clinical studies execution to generate data that substantiate the performance of Truvian’s breakthrough blood testing technology
- You'll work with a rock-star team of people who are passionate about the work they do and our ability to disrupt healthcare with our innovative products
- You’ll be a key player on a team responsible for the company’s growth and product launch
- You’ll thrive in a fast-paced and dynamic environment where you can implement fresh ideas new processes and make things happen quickly without a bunch of red tape
- You’ll have great perks such as Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K), paid parental leave, flexible PTO, Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks, on-site gym and virtual classes, and a farm to table onsite restaurant including a 30% discount
- Develop and implement clinical development strategies and plans that align with organizational goals, regulatory requirements, and industry best practices, including both internal and external clinical studies
- Oversee the planning, execution, and monitoring of clinical studies and trials, including study design, site selection, protocol development, clinical data management, and patient recruitment
- Implement processes for clinical study management and create necessary documents associated with the process, including SOPs, forms, and reports
- Work closely with cross-functional areas within the organization, including Regulatory, Assay Development, Engineering, Manufacturing, and Software, to ensure alignment on clinical development plans and timely delivery of study results
- Collaborate with external partners, including investigators and KOLs, to achieve study objectives and ensure high-quality data collection
- Analyze data, generate study-related metrics, and prepare and present regular report-outs on the status of clinical studies to senior management and other stakeholders, highlighting key achievements, risks, and issues
- Proactively identify and develop mitigations against anticipated risks and obstacles
- Create and collaborate on scientific publications, including manuscripts, abstracts, white papers, and posters, that report the results of clinical studies
- Clinical study management, including implementation of associated processes and documentation
- Achieving impossible timelines while staying within budget through a combination of superior planning, proven assessment of risk, and the ability to inspire and enable others to move fast
- Partnership and collaboration, ensuring relationships are at the forefront of our strategy, emphasizing the company and team over personal goals, and the ability to effectively
- Communicate, both oral and written, with the ability to communicate frequently, clearly, and timely while keeping both internal and external parties aligned to deliver impact at pace
- Business Tools, including experience implementing and working in project planning software, Microsoft Office products, statistical software, and more
- Problem-solving, with very strong analytical skills, which can be utilized to proactively identify and address issues with a solution-oriented approach with excellent time management skills
- Yes
- Regularly required to use hands to finger, handle, or feel, reach with hands and arms, and talk or hear
- Ability to lift and move over 25 lbs. repeatedly and safely, occasionally 75 lbs. with assistance
- Frequently required to stand, walk, stoop, kneel, crouch or crawl
- Occasionally required to sit and climb or balance
- Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus
Job Summary
JOB TYPE
Full Time
SALARY
$147k-186k (estimate)
POST DATE
07/14/2024
EXPIRATION DATE
07/11/2027
WEBSITE
truviansciences.com
HEADQUARTERS
San Diego, CA
SIZE
<25
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