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Join to apply for the Director, Clinical Affairs, Akura Medical role at Shifamed
This range is provided by Shifamed. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$185,000.00/yr - $210,000.00/yr
Akura Medical, a Shifamed Portfolio Company, is focused on a differentiated approach delivering an effective solution to address the major challenges of venous thromboembolism (VTE). Akura recently announced the first-in-human use of its mechanical thrombectomy platform. Each year VTE affects as many as 900,000 Americans, resulting in about 100,000 premature deaths. To learn more about Akura Medical, please visit 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 shall possess strategic, managerial, scientific, and tactical skillsets to lead and drive clinical activities, from early feasibility to pivotal studies to secure product approval and launch.
Responsibilities, Skills & Hands-On Experience:
- Provide subject matter expertise for clinical strategy, clinical trial design, and operations to ensure clinical trials and programs are completed on time, within budget, and with a high-quality outcome.
- Capable of evaluating, selecting, and managing Contract Research Organizations (CROs).
- Apply highest standard of clinical operational excellence, compliant with corporate objectives, contractual agreements, project plans, standard operating procedures (SOPs), federal and state regulations, GCP and ICH guidelines.
- Oversee and/or contribute to the preparation of clinical documents, e.g., protocols, report of prior investigations, case report forms and clinical study reports, monitoring plans, and budgets.
- Key contributor to clinical data, safety, and statistical management plans.
- Ability to oversee management of clinical data: collection, analysis and interpretation for presentations and reports.
- Serves as the subject matter expert on Akura project teams, as well as identifies and liaises with IRBs, CECs, DSMBs and KOLs regarding program strategy and scientific advice.
- Contribute to the publication strategy, abstract and manuscript writing, and regulatory submission activities to include interpretation of available clinical evidence.
- Contribute to writing and review of clinical documents for regulatory submissions.
- Support planning, logistics and insights reporting from clinical and scientific advisory board meetings and other clinical projects e.g., evaluation programs.
- Contributes to review and approval of risk management plans, design reviews, and IFUs, where clinical input is needed.
- Serve as company representative at external meetings, scientific congresses, etc.
- Ability to travel; establishing rapport with investigators, overseeing monitors as needed, troubleshooting, case coverage, etc.
- Solid knowledge of ISO 14155, 21 CFR Parts 50, 54, 56, 812 and 814, and other applicable international regulatory requirements.
- Proven experience in managing early medical device feasibility as well as pivotal studies, US and/or OUS.
- Ability to work as part of a team and as an individual contributor.
- Excellent verbal and written communication skills.
- B.S. in life sciences, bioengineering, biomedical engineering, mechanical engineering, electrical engineering, or similar discipline. Advanced degree preferred.
- 12+ years of proven experience in clinical trial management preferably in medical devices including a minimum of 5 years in a supervisory role managing clinical affairs staff.
- Familiarity with cardiovascular products and managing cardiovascular device trials.
- Structural heart therapy and previous CRA experience a plus.
Seniority level
Seniority level
Director
Employment type
Employment type
Full-time
Job function
Job function
Research, Analyst, and Information TechnologyIndustries
Medical Equipment Manufacturing
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