Senior Director, Global Clinical Development CNS- Psychiatry

2 weeks ago

Washington, Washington, D.C., United States Lifelancer Full time
About the Job

We are seeking a highly skilled Senior Director, Global Clinical Development CNS- Psychiatry to join our team at Lifelancer. As a key member of our organization, you will be responsible for designing and overseeing clinical research programs and protocols for our products under good clinical practices (GCP).

Job Description

The successful candidate will have a strong background in clinical medicine and science management, with experience in the pharmaceutical industry or academic translational clinical research. They will be responsible for evaluating and developing CNS and Digital Medicine products at different stages of development for a global healthcare market.

Key Responsibilities
  • Consult with patients, clinical, regulatory, and scientific leaders to optimize trial objectives, designs, and protocols.
  • Develop focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical, and other research project team members.
  • Author program strategies and oversee trials essential for determining the clinical safety, efficacy, medical usefulness, and value of drug or medical device product candidates.
  • Interpret and communicate results of Phase I-IV investigations in preparation for a new drug.
  • Act as the signatory on NDA submissions and clinical study and safety documents.
  • Provide strategic oversight in vendor and CRO relationships and provide clinical input into their governance committees.
  • Lead and support regulatory filing activities and documents, providing strategic direction and editing to provide concise, clear, and convincing argumentation in all written and verbal communications.
Requirements
  • A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist with prior management experience.
  • Experience in the pharmaceutical industry or academic translational clinical research, with a strong background in clinical medicine and science management.
  • A thorough knowledge of clinical medicine and science management, with the ability to communicate effectively in meetings and via written and oral presentations.
  • Demonstrated experience leading, managing, and motivating team members, with a strong understanding of drug development principles and clinical trial implementation, management, and reporting.
  • An advanced understanding of global regulatory requirements, with experience in successful regulatory filings.
Competencies
  • Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
  • Strategic Thinking Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
  • Patient Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
  • Impactful Communication - Communicate with logic, clarity, and respect, influencing at all levels to achieve the best results for Lifelancer.
  • Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
  • Empowered Development - Play an active role in professional development as a business imperative.

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