Regional Clinical Development Manager - PA, NJ, NYC - Remote, USA

Job Description

Job Description

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

The Regional Clinical Development Manager (RCM) is responsible for a broad range of activities including the leadership and management multi-level of Clinical Specialists and 1099 (independently contracted Clinical Specialists) for clinical support and case coverage of the CVAC procedure for the purpose of tactical execution of clinical objectives. The Regional Clinical Development Manager develops, manages, and delivers clinical education to sales, clinical specialists, marketing, surgeons, 1099 case coverage individuals and OR staff to achieve exceptional clinical outcomes for patients treated with Calyxo manufactured products. This position manages, in conjunction with Sales, to coordinate, develop, and deliver all New Hire Training content and deliverables. This position will manage and coordinate with Sales for case coverage needs and assist in the development of clinical team, its customers and Sales team members to procedure independence.

The Regional Clinical Development Manager will work in a cross-function capacity with Quality, Regulatory, Marketing, and R&D to develop clinical education around new product development, marketing materials, and ensure clinical input is provided to Quality and Regulatory teams.

In This Role, You Will:

Staff Management

• Throrough collaboration with Regional Business Managers and Territory Sales Managers this role will recruit, hire, train and manage a team of Clinical Specialists and 1099 Case Coverage individuals.
• Manage day to day deployment of these individuals to maximize efficiency and excellent clinical outcomes.
• Provide quarterly assessments and reviews.
• Conduct quarterly field rides to coach and develop clinical acumen and job development.
• Ensure and manage clinical competence-case sign-off, post new hire training.

New Hire Training

• Support the development and delivery of pre and on-site New Hire Training materials, and post training activities to independent support status.
• New Hire Training will include coordinating with sales to perform pre-new hire training to prep new hires for on-site new hire training.
• Assist with placing new hire attendees into procedures prior to attending New Hire Training.
• Perform live presentations, simulated role-plays, and hands-on simulated training.
• Work in conjunction to on-board all new hires post-new hire training to ensure clinical. excellence is achieved and tracked for FDA audits.

Case Coverage

• Work with Sales to perform case coverage assignments when a clinical and cross regional/divisional need arises.
• Assist with Sales to co-manage Clinical Specialist with Educational objectives for customers.
• Document aspects of case results and report the results to the Sales Consultant.
• Provide education deliverables to the surgeon and/or OR staff that may be needed.
• Sales will provide a clinical need upon requesting case coverage from the Regional Clinical Development Manager.

Cross-Function and New Product Development

• Clinical & Professional Education and its managers will partner with R&D and Marketing on managing and developing new product launches, market acceptance, case data follow-up reports, videos, video consents, and any other Market Acceptance Testing needed.
• Participate in labs looking at design changes and evaluating future product enhancements.
• Partner with the Sales team to deliver clinical deliverables to customers that enhance clinical outcomes and business relationships.

Other

• When necessary, the Regional Clinical Development Manager will co-manage customer-facing webinars.
• Manage and facilitate clinical breakout sessions as needed at meetings.
• Perform other duties as assigned.
• Contribute to our culture to be collaborative, respectful, transparent, ethical, efficient, high achieving, and have fun!

Who You Will Report To:

• Director, Clinical Excellence

Requirements:

• Bachelor's Degree
• 5+ years of clinical professional training OR and surgical based experience
• Demonstrated clinical mastery related to surgical devices and urology experience (preferred)
• Professional work ethic, strong organizational skills, and ability to perform at high levels independently
• Ability to travel 90% which includes overnight travel
• Meet vendor credentialing requirement and manage vendor credentialing needs at sites
• Strong interpersonal skill and experience training surgeons in the OR and working with Sales onboarding
• Proficient in ALL Microsoft office tools
• Ability to manage, edit and develop surgical videos and other training materials as needed
• Compliance with relevant county, state, and Federal rules regarding vaccinations.
• Must have valid US driver's license
• Ability to travel up to 90%. Overnight(s) is required
• Responsible for performing all duties in compliance with the FDA's Quality System Regulations

Physical Requirements

• The physical demands and work environment described here are representative of those and employee encounters while performing the essential functions of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear up to 8 hours a day
• The employee is regularly required to lift and carry up to 20 pounds.
• Duties also involve daily keyboard data entry
• Duties will be performed during travel and in home-office setting
• Employee is exposed to radiation and surgical site exposures. PPE must be obtained and utilized when performing all patient exposure activities
• Employee is regularly required to drive or fly to customer sites and is exposed to outside weather conditions. Employee is required to allow adequate time to ensure safe arrival to all customer facing activities

We also offer a compensation plan as follows:

• Competitive salary with a generous $180,000 base salary, $35,000 variable bonus, $9600 car allowance and $1800 cell phone/internet allowance per year
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth.

Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Disclaimer:

At Calyxo, we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:

• Structured Interview Process : Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
• Verification of Identity : We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
• Beware of Scams : Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of View email address on us.fitly.work. If you receive a request for information from any other domain, please contact us directly at View email address on us.fitly.work to verify the legitimacy of the communication.

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.