Executive Director, Clinical Operations
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Job Location:
Newark, DE - USA
Monthly Salary:
$ 282000 - 346000
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
Description
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Position Summary:
The Executive Director Clinical Operations will oversee the Clinical Trial team including all clinical trial personnel. This role will act as liaison to the Data Management QA and CMC teams. This position will maintain effective communication with the team and all Clinical Operations service providers. The incumbent will work closely with the Clinical Program Management team with CROs and clinical vendors to ensure that all assigned operational trial deliverables are met according to established timelines budget operational procedures quality standards SOPs and business guidelines.
Responsibilities:
- Provide recommendations and implement strategic milestones to ensure optimized clinical development plans for assigned projects
- Provide guidance to the Clinical Operations Leads to identify opportunities to optimize and streamline the delivery of clinical trials
- Provide direction and leadership in CRO and Vendor selection and management
- Establish external best practices and standards of working with Clinical Operations Service Providers including effective communication
- Oversee and participate in initial and Vendor Assessments in collaboration with QA in conjunction with the Clinical Operations Leads and SMEs
- Partner closely with cross functional teams including Biostatistics Data Management Drug Safety CMC and Supply Chain Project Management and Regulatory to optimize operational excellence and improvements
- Build manage and cultivate high performing clinical teams and mentor new employees
- Create and manage the clinical operations budget and ensure clinical projects remain on schedule and within budget
Qualifications:
- Bachelors degree with 12 years of related leadership experience in the pharmaceutical or biotechnology industry or equivalent experience
- Strong organizational presentation documentation and interpersonal skills as well as a willingness to work within a team-oriented environment
- Direct and control the activities of a broad functional area through partnership with cross- functional department managers within the company
- Overall control of planning and strategic innovation; recommend and implement changes to current methods to increase efficiency and reliability
- Effective leadership skills and proven ability to foster team productivity and cohesiveness
- Strong organizational presentation documentation and interpersonal skills as well as a willingness to work within a team-oriented environment
- Excellent teamwork and collaboration skills with attention to detail
- Working knowledge of clinical trial systems (CTMS EDC eTMF)
- Strong knowledge of ICH/GCP guidelines and multinational clinical trial regulations
The anticipated annualized base pay range for this full-time position is $282000 - $346000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors including years of relevant experience training qualifications and internal equity. The compensation package may also include an annual bonus target and equity awards subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees including a 401(k) plan with generous employer match 12 weeks of paid parental leave up to 12 weeks of living organ and bone marrow leave equity incentive plans health plans (medical prescription drug dental and vision)life insurance and disability flexible time off annual Winter Holiday shut down and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
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
About Company
From discovery through commercialisation, all of us at Ardelyx are driven to advance targeted therapies where significant medical needs persist.
