Marinus Pharmaceuticals, Inc.

Clinical Program Director

Location
Villanova Area
Posted
Jun 21, 2018
Required Education
Bachelors Degree
Position Type
Full time

 

Do you want to make a difference?

At Marinus, we are bringing hope to patients by developing new treatments to improve the lives of patients and families affected by epilepsy and neuropsychiatric disorders.  We are comprised of a team of highly qualified individuals committed to developing new therapies for CNS disorders and we are passionate about making a positive difference in the lives of the patients we serve.

We are growing and seeking new team members

 We have multiple clinical programs and are expanding our clinical operations group.  We are seeking a Clinical Program Director to  support our trials in Pediatric Orphan Indications and Postpartum Depression.  We are in the process of initiating a Phase 3 global study in children with CDKL5 deficiency disorder, a rare genetic epilepsy with no approved therapies. We have studied other disorders that affect pediatric patients such as PCDH19 related epilepsy, Lennox Gastaut Syndrome, and Fragile-X Syndrome, some of which we may consider further studying in the future.

We are currently enrolling patients in our two Phase 2 clinical trials in women with postpartum depression – The Magnolia and Amaryllis Studies.  Post-Partum Depression can affect a mother’s ability to care for her child and negatively affect a child’s cognitive development.  The most common medications prescribed to women who seek treatment for PPD are SSRI’s and SNRI’s which have limited evidence of efficacy.  There are currently no approved therapies to treat PPD.

We provide very competitive compensation and benefits packages.

To learn more about our company please see our website 

http://www.marinuspharma.com/

To apply, please attach your resume in word or a pdf using this format: last name, first initial Director or send to 

HR@marinuspharma.com

Clinical Program Director

Provides 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. Open effective, and proactive communication of the clinical development activities is critical for success in this role.

Must have strong leadership skills and be able to work independently and productively.

Responsibilities

  • Proactively manage all operational aspects of the clinical trials within assigned global programs including but not limited to management of trial timeline, budget, resources and vendors.
  • Represent Clinical Operations Project Team meetings providing updates including status of trial-level activities, program initiatives, etc.
  • Coordinate trial activities, vendors, sites and CROs; build and maintain effective working relationships with interfacing groups.
  • Ensure effective project plans are in place and operational for each trial and work proactively with the clinical trial team members (both internal and external) to set priorities, operational procedures, policies, guidelines and regulatory requirements.
  • Ensure study risks are appropriately escalated to the Executive Director of Clinical Development and Operations.
  • Monitor the quality of vendor deliverables, address quality issues and identify opportunities to improve training, execution and data flow across all trials within assigned program.
  • Review and approve vendor invoices in collaboration with Accounting team to ensure payments are issued in a timely manner based on levels of authority.
  • Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements.
  • Foster and cultivate relationships with key opinion leaders and other experts in the CNS community.
  • Chair and lead clinical trial team meetings and ensure meeting minutes are completed, distributed to team members and filed in a timely manner.

Skills, Education, and Experience Required

  • BS in the life sciences or related discipline, at minimum
  • 8 or more years of clinical operations experience, with increasing levels of responsibility,
  • A minimum of three years’ experience of current clinical project management experience leading trial teams.
  • Therapeutic experience in CNS, preferred
  • Experience in early phase trials (Phase I-III)
  • Experience in managing global clinical trials
  • Ability to work both independently and as part of a team demonstrating excellent communication and interpersonal skills is required.
  • Excellent working knowledge of FDA, GCP and ICH guidelines
  • Experience working with foreign regulatory agencies (e.g. EMA), preferred

Marinus is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.