Marinus Pharmaceutical Hiring For Director, Clinical Operational Excellence at Radnor, PA  Full Time

Full Time
Remote, Remote, US
Professional
1167

Marinus is a commercial stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders.

Headquartered in Radnor, PA, we are a hybrid team of dedicated and talented professionals who value innovation, are committed to developing new therapies for patients with rare epilepsy and seizure disorders and are passionate about making a positive impact on our patient and local communities.

We are currently searching for an experienced professional to join our team as a

Director, Clinical Operational Excellence

Reporting to the Vice President, Clinical Development Operations (CDO), the Director is responsible for driving process/system optimization, best practices with adherence to regulatory and industry standards, is an expert in efficiency and innovation of all aspects of clinical trials with strong focus on trial set-up for long term success.

Key responsibilities include but not limited to the following:

Drive operational excellence and data quality

• Optimize site start-up and close-out processes, site engagement and recruitment initiatives, and real-time data capture and evaluation.
• Steer trial operations process creation or improvement aligned with R&D leadership vision for scalable trial delivery capability.
• Lead CDO training on processes and conduct routine quality internal reviews for inspection readiness.
• Enhance patient and site-centric approaches and study risk management.

Operational model and resource management

• Assist VP CDO with trial execution model (in-house/outsource by phase and geography), and related contract CTM/CRA resource allocation and contract management.
• Refine and support study budget creation, cost control and reforecasting in partnership with Finance and Sourcing departments.

Study timings, metrics, and corporate goals

• Standardize study milestones, metrics, and process/controls to incorporate in product-level project plans. Set goals for improvement with process efficiency and new technologies.

Business intelligence

• With internal business partners identify and respond to opportunities or threats such as new regulation, technologies or competing trials.

Qualifications:

• Minimum Bachelor’s degree is required, preferably in a scientific discipline. Advanced degree preferred
• Minimum 10 yrs of experience within the Pharmaceutical/Biotech industry
• Experience with clinical trial conduct and data quality
• Sponsor experience is preferred
• Demonstrated experience of establishing right-sized organization, processes, functional capabilities and technology for a rapidly evolving company. Deep appreciation of strategic business imperatives and ability to make difficult choices and prioritize.
• Expert knowledge of GCP, ICH and national regulatory requirements for clinical trial conduct, and compliance requirements of pre- and post-commercialization interactions with healthcare providers.
• Experience with NDAs or other regulatory submissions
• Line management experience is preferred
• Proven track record of successful sponsor, site, and vendor inspections.
• Strong communication skills, problem solving skills and collaboration skills.
• Up to 20% travel is required based upon business needs

At Marinus, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

All employment is decided on the basis of qualifications, merit, and business need

Search Firm Representatives Please Read Carefully

Marinus Pharmaceuticals does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.

Please see job description

PI190069104