Careers

Director of Clinical Research Operations

Responsible for the overall execution of clinical trials (projects), accountable for the study start-up activities, budget and timeline management, organization, administration and execution of the clinical trial from start to finish, compliance with GCP, IHC, SOPs, internal/departmental guidelines. Works collaboratively with individuals cross-functionally across the organization. Primary contact for sponsors/CRO, clinical sites and vendors. Prioritizes activities with competing deadlines and ensures goals are met. Recommends leads and implements tactical process improvements. Responsible for contributing to a culture of process improvement, performance measures, project prioritization, and developing successful solutions. Provides clear direction, with timelines for supporting members of the project (budget, contracts, regulatory, pricing, network operations, others). Provides supporting members with information they need to successfully complete their job for InGeneron.

Position Description:

• Manage the study start- up process including site list delivery, team process report completion, project map with clear timelines for the project and all supporting team members accountable to the project. Responsible to outline expectations to internal teams and sponsor/vendors to ensure successful study implementation.
• Applies subject matter expertise to align InGeneron clinical activities with industry best practices.
• Protocol Review: understand and be the protocol owner. Review protocol procedures for standard of care vs. research related charges. Provide all supporting team members with the information and contacts they need in order to complete their tasks.
• Responsible for managing, implementing and executing the day-to-day operations, functional activities and deadlines of the InGeneron Inc. clinical trials.
• Creates, maintains, and ensures compliance to clinical procedures, SOPs, and forms.
• Develops and maintains standard and administrative operating procedures (SOPs and AOPs) and other related tools.
• Directs, oversees, trains, mentors and leads internal and external clinical teams.
• Makes appropriate decisions to prioritize, operationalize and drive performance.
• Demonstrates commitment and subject matter expertise to accelerate and improve study start-up processes, timelines and work flows.
• Promotes and maintains organizational efficiency and effectiveness. Measures performance and provides management with regular status updates on productivity, progress of the trials and alliances; and identifies opportunities for improvement.
• Identifies new clinical trials and strategic opportunities.
• Participates in planning and resource allocation decisions including interviewing, hiring and on-boarding of selected candidates. Identifies mentoring/training needs and promotes staff development opportunities.
• Maintains up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas including key clinical development topics.

Qualifications and Skills:

• Clinical trial operations and advanced management skills
• Proven leadership, mentoring and supervisory skills
• Superior organizational and change management skills
• Advanced public speaking, writing, presentation and negotiating skills
• Ability to delegate tasks appropriately, influence behavior and drive performance
• Advanced working knowledge of study start-up activities (i.e., feasibility, budget development, contract negotiation and regulatory affairs)
• Advanced computer skills, including Microsoft Office suite (including MS Project, Excel, and PowerPoint), and clinical trial management systems
• Ability to travel
• Accountable, proactive, passionate, strategic, innovative, open, mature and flexible

Experience and Education:

• Advanced life sciences degree or combination of equivalent education and experience
• CRO/Device company experience managing multi-site clinical trials
• 5+ years of clinical research operations management-level experience
• Excellent knowledge of ICH GCP guidelines; CRA/CRC certification preferred
• Strong project and change management skills required; lean six sigma training a plus
• CRO/Device Industry and/or start-up environment experience preferred
• Orthopedic Device experience- preferred
• project and/or change management: 3 years
• management-level clinical research operations: 5 years
• CRO/Medical Device: 5 years

Benefits:

• 401K
• Medical
• Dental
• Life
• Vision

Location:

• InGeneron Inc Houston, TX, USA

Please e-mail your resume to or contact us at [email protected] any time if you have questions.

Regulatory  Specialist

The Regulatory Specialist will coordinate, prepare, or review regulatory submissions for domestic or international projects by preparing regulatory or compliance documentation to local and central IRBs and coordinate/submit regulatory documentation for IRB approval of clinical materials and documents. Additional activities include the review of promotional materials for compliance with applicable regulations and policies in the conduct of clinical research. The candidate must maintain a current knowledge base of existing and emerging regulations, standards, or guidance documents and update this knowledge of legal or regulatory changes to external and internal teams by interpreting regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

Position Description:

• Compile and maintain regulatory documentation databases or systems.
• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Communicate with regulatory agencies regarding clarification and follow-up of submissions under review
• Review product promotional materials and study documents for compliance with applicable regulations and policies.
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Participate in internal or external audits.
• Prepare or maintain technical files as necessary to obtain and sustain product approval.
• Recommend changes to company procedures in response to changes in regulations or standards.
• Review clinical protocols to ensure collection of data needed for regulatory submissions.
• Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.

Requirements:

• 2+ years in Sponsor or CRO level experience
• Bachelor’s degree or higher in related field
• Experience working in Regulatory affairs
• Strong organizational skills
• Strong computer skills

Please e-mail your resume to or contact us at [email protected] any time if you have questions.

Clinical Field  Educator

The Clinical Field Educator is responsible for Customer Success including creating training for sites and site feedback to the company for our clinical-stage products at InGeneron, a medical device company. The Clinical Liaison will ensure that customers, including clinical trial sites, are trained and provided with appropriate scientific and technical knowledge about our products and the science and affiliated research behind them for successful clinical operation. The Clinical Liaison will also ensure that usability, safety, and operational feedback reaches appropriate people at InGeneron.
This position works directly with Principal Investigators and the staff at clinical trial sites, and directors of Engineering, Clinical Research Operations, and Regulatory. Reporting to the Director of Clinical Research Operations and located in our Houston, TX office, the position has approximately 70% travel, generally to the US, though to include the EU.
You will promote our company and products by attending conferences and seminars, cultivating relationships, and conducting presentations. You will explain our products and technology to potential clinical sites and customers.

Position Description:

• Provide training to clinical sites and clinical trial sites.
• Report usability, safety, and customer feedback to InGeneron.
• Maintain knowledge of competitors’ activities and understand our market position.
• Travel to and audit potential clinical trial sites for acceptability.
• Attending seminars and conferences to promote the company and products.
• Collaborating with product development to incorporate best practices and customer requests.
• Communicating activities and concerns to the supervisor.
• Completing required paperwork, managing correspondence and maintaining data in CRM.
• Submit a monthly report of field activities, identifying unique observations and trends.
• Provide a list of meetings with contacts and a summary of discussions, identifying opportunities for KOLs or future sales.
• Track key metrics identified above and submit in a report.
• Submit Site-Reports within reasonable time post-site-visit on usability, safety, and operational feedback to InGeneron.
• Meet with PI and key personnel at each site visit to discuss identified needs for site training on IP, ancillary equipment and materials, and study protocol.
• Evaluate and report on the necessity to establish a lipo training program provided and hosted by InGeneron to orthopedists engaged in the study.

Benefits:

• 401K
• Medical
• Dental
• Life
• Vision

Location:

• InGeneron Inc Houston, TX, USA

Please e-mail your resume to or contact us at [email protected] any time if you have questions.

Position Summary

This position is based at our Houston, TX office. The incumbent will be responsible for maintaining all our vendor accounts in good standing along with processing receipt of payments in a timely fashion. Your responsibilities in this role will support our general accounting department and play a crucial role within our monthly financial operations and month end close. This position requires a basic understanding of double-entry bookkeeping. The ideal candidate will also have great troubleshooting abilities and attention to detail.

Responsibilities

Support our CFO in:

• Monitor and maintain AP/AR inbox; serve as point of contact for customers and vendors to answer any billing/payment inquiries that come in through phone or e-mail
• Review, scan, process and code vendor invoices daily
• Record transactions by posting them to various accounts and document transaction details
• Have knowledge of and perform ad hoc payment requests via credit card, ACH, Zelle, wire transfers, issuing check through QuickBooks Desktop
• Must be highly detailed in processing payment to vendors
• Follow-up on outstanding invoices
• Conduct periodic reconciliations of all accounts, including bank reconciliation in QuickBooks Desktop
• Provide various financial reports to the management team such as balance sheets and reports of monthly payment initiated
• Work with the Munich, Germany team on monthly accounting operations, functions, and projects. No language requirement: English is preferred

Requirements

• High School diploma or GED required
• Associate degree or Bachelors Degree in Accounting, Finance, or Business Management is preferred
• Minimum two (2) years experience within bookkeeping, accounting or finance is required
• Accounts Payables knowledge is required
• Intermediate knowledge of accounting principles is strongly preferred
• Experience with General Journal Entries posting is required
• Minimum one (1) year experience with QuickBooks Desktop; 2+ years is highly desirable
• Minimum two (2) years experience with Microsoft Outlook and Excel (function knowledge and pivot tables) is required
• Canidate must be professional and have exceptional communication in English both written and verbal
• High degree of attention to detail and good record-keeping is required
• Experience working in healthcare accounting or medical device accounting preferred but not required
• Hands-on, ambitious candidate who is interested in joining a small company with big growth plans
• Good organizational skills and ability to handle multiple task simultaneously
• Willing to take initiative and think outside the box

Benefits

We are a privately held company and we offer unlimited potential for motivated professionals. We also offer a competitive salary. Overtime opportunities are available with this position.

You want to shape the future of medicine and become part of an ambitious team?

Send us your application to [email protected].

Business Development & Market Analyst – Student Intern

As our student intern in business development and market analysis in Houston, TX you will participate in and lead projects centered around validating our existing business model and refining our go-to-market strategy. You will be exposed to a wide range of MedTech business development topics including sales & marketing, regulatory affairs, and reimbursement. This is a full-time position, 40 hours per week, with flexible start and end dates depending on your school’s schedule. You can expect a hybrid working environment with the option of working from a home office 2 days per week.

Position Description:

• Create in-depth reports updating business model assumptions and exploring future growth opportunities.
• Assist in conducting expert interviews to refine our go-to-market plan.
• Assist with financial modeling through research and assumption testing.
• Create case studies based on other companies to evaluate different business strategies.
• Help develop communications material for investors and potential partners.

Requirements:

• Convincing academic track record.
• Excellent writing skills.
• Creativity and entrepreneurial mindset.
• Routine in working with Microsoft Office.
• Pursuing a degree in business or marketing.
• Ability to work in an independent manner and willingness to take responsibility.
• Interest in scientific, particularly medical topics and their commercialization.
• Ambitious goals for your own professional development.
• Team player and willing to go the extra mile.

Preferred Skills:

• Experience in WordPress
• Experience working with Power BI, PowerPoint, and Excel.
• Scientific literacy (e.g. biology, healthcare, or research experience through college coursework).

Please e-mail your resume to or contact us at [email protected] any time if you have questions.

Marketing & Public Relations – Student Intern

As our student intern in marketing and public relations in Houston, TX you will participate in and lead external as well as internal marketing and public relations projects. You will assist in managing digital advertising campaigns, social media accounts, and our website. This is a full-time position, 40 hours per week, with flexible start and end dates depending on your school’s schedule. You can expect a hybrid working environment with the option of working from a home office 2 days per week.

Position Description:

• Support the development and implementation of a multi-year communications roadmap with the goal to build the InGeneron brand.
• Manage our communications channels, such as our website and social media presences.
• Create website content (e.g. informational articles, blogposts) for physicians and patients.
• Create and coordinate press releases around major milestones, such as fundraising events or results of clinical trials.
• Help develop communications material for clinical research partners in the U.S.

Requirements:

• Convincing academic track record.
• Excellent writing skills.
• Creativity and entrepreneurial mindset.
• Routine in working with Microsoft Office.
• Pursuing a degree in communication, PR, advertising or marketing.
• Ability to work in an independent manner and willingness to take responsibility.
• Interest in scientific, particularly medical topics and their communication.
• Ambitious goals for your own professional development.
• Team player and willing to go the extra mile.

Preferred Skills:

• Experience in WordPress
• Experience with SEO.
• Experience working with Facebook & Google ads.
• Routine in working with Adobe Photoshop and InDesign.
• Scientific literacy (e.g. biology, healthcare, or research experience through college coursework).

Please e-mail your resume to or contact us at [email protected] any time if you have questions.