| Tioga Cardiovascular, a Shifamed Portfolio Company, is developing a minimally invasive, transcatheter mitral valve replacement therapy that is both easier to use and implantable in a higher percentage of patients with mitral regurgitation. To learn more about Tioga Cardiovascular, please visit www.tiogacardiovascular.com. ABOUT SHIFAMED Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology. Description: The Director of Clinical Affairs and Operations is a strategic and hands-on leader responsible for driving clinical programs from early feasibility through pivotal trials to regulatory approval and market launch. This role combines deep scientific expertise, operational excellence, and cross-functional leadership to ensure clinical trials are executed efficiently, compliantly, and with high-quality outcomes. Responsibilities, Skills & Hands-On Experience: - Lead clinical strategy, trial design, and execution across all phases of development, ensuring alignment with corporate goals and regulatory requirements.
- Oversee selection, negotiation, and management of Contract Research Organizations (CROs) and other clinical vendors.
- Design, plan, and manage clinical trials including protocol development, site recruitment, compliance approvals, budget and contract negotiation, study initiation, monitoring, data analysis, and reporting.
- Apply strong organizational skills to manage multiple complex projects and timelines simultaneously.
- Navigate and manage challenging stakeholders with professionalism and tact, ensuring alignment and collaboration across internal and external teams.
- Demonstrate strong negotiation skills in vendor contracts, site agreements, and cross-functional decision-making.
- Ensure adherence to GCP, ICH, ISO 14155, and applicable FDA regulations (21 CFR Parts 50, 54, 56, 812, 814).
- Develop and review clinical documentation including protocols, case report forms, monitoring plans, study reports, and regulatory submissions.
- Serve as subject matter expert on cross-functional project teams, interfacing with IRBs, CECs, DSMBs, and Key Opinion Leaders (KOLs).
- Contribute to publication strategy, including abstract and manuscript development, and support scientific and clinical advisory board meetings.
- Provide clinical input into risk management plans, design reviews, Instructions for Use (IFUs), and product labeling.
- Represent the company at external meetings, scientific congresses, and investigator interactions.
- Travel as needed for site visits, investigator meetings, case coverage, and troubleshooting.
Education & Work Experience: - Bachelor’s degree in life sciences, bioengineering, biomedical engineering, mechanical/electrical engineering, or related field; advanced degree preferred.
- Minimum of 10 years of experience in clinical trial management, preferably in medical devices.
- At least 3 years in a leadership role managing clinical affairs teams and external partners.
- Proven ability to lead and manage clinical trials from feasibility to pivotal stages, both in the U.S. and internationally.
- Strong understanding of clinical data management, safety reporting, and statistical analysis plans.
- Exceptional organizational and stakeholder management skills.
- Effective negotiator with experience in clinical contracts and vendor management.
- Experience with cardiovascular devices, especially structural heart therapies, is highly preferred.
- Excellent communication skills, both written and verbal, with the ability to present complex data clearly.
- Ability to work independently and collaboratively in a fast-paced, cross-functional environment.
- Prior experience as a Clinical Research Associate (CRA) is a plus.
Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time position is between $180,000 - $210,000 + equity + benefits. NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.
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