Marinus Pharmaceutical Looking for Director, R&D Program Management at Radnor, PA  Full Time

Full Time
Remote, Remote, US
Professional
1194

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

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 a

Director, R&D Program Management

Marinus Pharmaceuticals is seeking a highly motivated and experienced individual who will be responsible for driving the cross-functional execution of R&D activities across the brand. The PM will partner with leaders and teams across R&D, and the broader company, to efficiently and effectively deliver on strategic priorities and related projects across all phases of the product and program lifecycle.

Responsibilities include but not limited to the following:

• Work collaboratively and cross-functionally to coordinate, manage, and deliver seamless execution of global R&D strategic objectives.
• Provide project management support to global product development teams and sub-teams for the development and approval of new and existing drug/indication/formulation candidates.
• Under the direction of the regulatory lead, define, track, oversee and monitor the delivery of content needed for regulatory submissions working in collaboration with medical writing to oversee the success of applicable cross-function teams. Content could include INDs/CTAs, BLAs/MAAs (Modules 1-5), meeting requests, briefing packages, responses to health authority requests.
• Collaborate with R&D members of company-wide program and product teams to develop and maintain high-quality, integrated, project plans (IPPs) that align with overall program and R&D strategies. Drive associated communication, scenario planning and decision making. Ensure timely execution of R&D portions of IPP.
• Ensure alignment of R&D and broader organizational timelines and deliverables.
• Facilitate the identification, management, and communication of key risks to the project plan and their associated mitigation and contingency plans.
• Develop and implement stage appropriate and value-added processes, best practices, and tools (integrated development and approval timelines including clinical, preclinical, regulatory, CMC, drug supply and other processes) to increase efficiency and consistency of R&D processes/deliverables.
• Drive the creation and execution of best practices, template, procedures, and tools to expand program management capabilities within the organization.
• Leverage strong project and organizational knowledge, leadership, and facilitation skills to optimize team meetings and facilitate effective governance and decision making.
• Build and leverage relationships and networks across R&D and the broader company to improve and enhance team dynamics; proactively identifying opportunities and removing obstacles to drive business results

Qualifications:

• Bachelor’s degree is required (degree in science, engineering or related discipline preferred); Advanced degree preferred
• Minimum 10 years of experience in the pharmaceutical/biotech industry
• Experience in cross-functional drug development from Phase 1 through approval.
• Minimum 7 years of project management experience, including tracking and planning of cross-functional product development projects.
• Prior experience supporting (as a project manager) an NDA/BLA/MAA application is preferred.
• In-depth R&D knowledge with understanding of functions relevant to the position which includes Regulatory, CMC, Preclinical, Clinical, and Manufacturing.
• Excellent business acumen, leading and facilitating project team meetings, cross-functional communication and decision making, and ensuring ongoing alignment with internal/external stakeholders.
• A proactive and strategic thinker, with strong facilitation, problem-solving and issue resolution skills.
• Operating knowledge of key software tools including Excel, PowerPoint, OnePager MS Project, and Smartsheet.
• Highly collaborative with outstanding communication and relationship management skills.
• Adaptive leadership style with ability to influence teams without formal authority.
• Ability to work effectively with cross-functional teams.
• PMP credential and experience with latest PM tools, software and processes preferred.
• Up to 15% travel may be 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

PI201982641