Vice President, Clinical Affairs

Job Title:           Vice President, Clinical Affairs

Reports to:       CEO

Location:          Dallas, TX – Remote work may be an option for those unable to relocate

 

Position Summary:

Osteal Therapeutics, Inc. is a clinical-stage company developing a novel pipeline of drug/device combination therapies for treatment of musculoskeletal infections and their consequences. Our lead investigational candidate, VT-X7 was granted Orphan Drug, FastTrack and Qualified Infectious Disease Product designations by the FDA and is currently in Phase 2 comparative trials for treatment of Periprosthetic Joint Infection (PJI). With a robust pipeline of additional indications and therapeutic candidates, we anticipate rapid and sustained growth.

Osteal is looking for an experienced Vice President of Clinical Affairs to build and lead our clinical development and operations team. Reporting to the CEO, the VP, Clinical Affairs will be an important member of the executive team, providing strategic and operational leadership in the development, implementation, and oversight of a robust clinical trial program to support Osteal’s current and future products. This is an opportunity for an experienced clinical executive to get involved early and play a central role in shaping all clinical activities at the company.

 

Essential Responsibilities:

  • Develop and execute worldwide clinical study strategy including management of ongoing multicenter, randomized controlled trials to drive rapid FDA approval of VT-X7.

  • Work closely with Regulatory Affairs to outline and prioritize future pre-and-post market clinical studies.

  • Develop and lead clinical data strategy inclusive of data collection, data management, analytical method development, analysis, as well as process to consistently review data and identify relevant insights.

  • Collaborate with Marketing to incorporate strategies for driving site engagement and rapid trial enrollment.

  • Lead development and execution of publication strategy, identifying cross-functional needs, optimal data and insights to publish, and work closely with KOLs to present and publish.

  • As a member of the Executive Leadership Team collaborate on corporate strategy, operating plan / budget development, and corporate culture development. Serve as clinical expert in strategic meetings and consistent reporting to Board of Directors.

  • Effectively plan and execute trials including models for predicting study cadence, resource needs, and key metrics to track progress as well as programs and tools to ensure trials are completed on schedule.

  • Author clinical components of regulatory submissions.

  • Develop and manage department budget and resources, IRB/EC submissions, legal agreements with sites, purchasing, protocol execution, by and contracting.

  • Ensure compliance to study protocols, domestic and international Good Clinical Practices, applicable regulatory standards, and Osteal’s Standard Operating Procedures.

  • Monitor and report on changes in the clinical landscape as they pertain to regulatory, compliance and overall best practices.

  • Develop clinical protocols, statistical analysis plans, pharmacovigilance plans, safety oversight (DSMB), investigator’s brochures, ICFs, CRFs, monitoring plans, clinical reports, and other documents in compliance with ISO 14155 and other relevant standards.

  • Build and manage relationships with clinicians including Scientific Advisory Board, KOLs, and investigators to develop clinical strategies, protocols, analysis and study execution.

  • Contract and oversee CROs as required, managing costs and tracking deliverables.

  • Build, manage, and mentor clinical development and operations team.

  • Operate as a team player in a fast-moving clinical-stage startup

Experience/Skills:

  • BS/BA degree with 10+ years of medical device and biopharmaceutical clinical development experience with demonstrated success in a senior leadership role.  Some surgical device experience preferred; infectious disease experience a plus.

  • Experience building and leading teams to plan and execute randomized clinical trials to support regulatory approval and commercialization of new medical devices, pharmaceuticals or combination products.

  • Experience interacting with regulatory bodies on matters of clinical development.

  • Ideal candidate has served as senior clinical leader in start-up company with a demonstrated ability to develop and execute clinical development strategic plans, to develop contingency plans, to provide technical and strategic advice, and to meet milestones and budgets.

  • Able and willing to switch between strategic and tactical execution as resource availability dictates.

  • Adept at development of credible and collaborative relationships with physicians.

  • Results driven; collaborative team player capable of working well with others.

  • Proven and effective team builder and leader

  • Ability to work independently and balance multiple priorities in a fast-paced, FDA-regulated environment.

  • Strong verbal and medical writing communication skills.

  • Strong organizational and planning skills with an attention to detail.

  • Thorough understanding of US and international standards and regulations, including but not limited to Good Clinical Practices (GCPs), Quality System Regulations (QSRs), general clinical stage Standard Operating Procedures (SOPs).

  • Willingness and ability to travel regularly (up to 30%).