Marinus Pharmaceutical Hiring For Associate Director, Clinical Development Operations at Radnor, PA  Full Time

Full Time
Remote, Remote, US
Management
1134

Marinus Pharmaceuticals is a clinical stage biopharmaceutical company committed to developing breakthrough therapies to improve the quality of lives of patients and their families as they battle rare and life-threatening diseases.

Based in Radnor, PA we are a team of dedicated and talented professionals who value innovation and commitment to developing new therapies for CNS disorders and are passionate about making a positive difference in the lives of our patients.

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

Associate Director, Clinical Development Operations (CDO)

Reporting to the Senior Director/Executive Director, the Associate Director will provide leadership, project management and program oversight to plan and conduct multiple high quality global clinical trials concurrently. The incumbent will manage all operational aspects of clinical development projects. Note: a “project” is defined as a study and a “program” is defined as a group of studies.

Key responsibilities include but not limited to the following:

• Serves as an SME for the clinical program strategy & liaison between project team(s), CDO staff and department Leadership as well as other external key stakeholders (i.e., PM, CMC, QA, etc.)
• As appropriate, consults with other stakeholders including external partners and other internal departments to ensure well-informed decisions and sound strategy at the program level (e.g., SOPs, program-level initiatives related to, discovery, R&D, commercialization, and post-marketing commitments)
• Develops operational standards and reinforces consistency in execution among programs
• Ability to identify project- and program-level concerns and collaborate with core or internal and external stakeholders in support of effective solution(s)
• Collaborates with PM to develop / maintain program timelines and proactively communicates proposed efficiencies, challenges and solutions with budget impact in mind
• Proactively communicates employee performance to CDO Leadership (e.g. individual, project team, program-level, cross-functional team External Service Providers)
• Actively leads / participates in key meetings (e.g. CDO Core Leadership, Project/Program/Service Provider Governance, Development Team (DT), Strategic Leadership Team (SLT) (where appropriate)
• Provides leadership, oversight and strategic perspective to weekly project team meetings
• Accountable for executive reporting of program updates in weekly strategy team meetings or other meetings as requested (ie. Board meetings)
• Performs all activities in close collaboration with team(s) to enable better management, support, and development of project team / program members and employees
  1. Successfully manages conflict to resolution escalating or communicating with CDO Leadership when appropriate
  2. Effectively able to delegate and oversee activities
• Model behavior consistent with a leader to gain and maintain respect of others (e.g., peers, subordinates, management, leadership, internal/external stakeholders)
• Fully accountable for efficient operations, quality deliverables and budgetary aspects of the program

Qualifications:

• Minimum Bachelor’s degree or RN with equivalent related work experience is required
• Minimum 8 yrs of industry related experience required
• Experience managing people, vendors and budgets is required
• Extensive Global Clinical Trial experience is required
• CNS experience is preferred
• Experience in Hospital Based / In-patient clinical trials is preferred
• Must have strong knowledge of ICH / GCP / FDA guidelines required
• Proven project management skills and study leadership ability required.
• Must have excellent interpersonal, written and verbal communication skills, and administrative skills.
• Excellent computer skills with: MS Word, PowerPoint, Excel and Project
• Up to 15% 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

PI175970374