Director, Clinical Affairs & Operations
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Job Location:
Los Gatos, CA - USA
Monthly Salary:
$ 180000 - 210000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 .
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).
- 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:
- Bachelors 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 $180000 - $210000 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
Required Experience:
Director
Key Skills
- Employee Relations
- Employee Evaluation
- Management Experience
- Profit & Loss
- Conflict Management
- Operations Management
- Project Management
- Budgeting
- Leadership Experience
- Supervising Experience
- Leadership management
- Financial Planning
