Director, Clinical Affairs, Akura Medical
Director, Clinical Affairs, Akura Medical
Posted on :
23-07-2025
Employer Active
1 Vacancy
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Yearly Salary
$ 185000 - 210000
Vacancy
1 Vacancy
Posted on :
23-07-2025
Job Description
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 900000 Americans resulting in about 100000 premature deaths. To learn more about Akura Medical please visit .
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 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 ISOCFR Partsand 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.
Education & Work Experience:
- 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.
Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge location skills experience relevant education and training/certifications and the job title may be assessed one level lower or higher accordingly. The base salary range for this full-time position is between $185000 to $210000/year equity benefits.
Required Experience:
Director
Employment Type
Full-Time
Key Skills
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