Neuropsychiatry Clinical Development Director

ADP, Inc.; Harmonville (PA); On-site; USD 200,000 - 320,000; Full time

Benefits offered by this job

Medical, Vision and Dental benefits

Paid time off and holidays

Disability benefits and Life Insurance

401(k) Retirement Savings Plan

Paid Parental leave

Employee Stock Purchase Plan (ESPP)

Wellness programs

Professional development opportunities

Great Place to Work recognition

Job summary

Harmony Biosciences is seeking an Executive Director, Clinical Development Neuropsychiatry Franchise Lead to drive program strategy and clinical execution in the Plymouth Meeting office. This senior role leads cross-functional teams, oversees trial design, data interpretation, regulatory submissions, and safety considerations for neuropsychiatry programs.

The ideal candidate has an advanced degree and 12+ years of pharma/biotech experience, with a strong record in NDA submissions, leadership

Qualifications

• Advanced degree required in psychiatry; PhD, MD or PharmD strongly preferred.
• 12+ years of clinical development experience within pharma/biotech/CRO with leadership of clinical programs; knowledge of GCP is required.
• Proven track record leading positive clinical studies and contributing to NDA submissions; cross-functional leadership.
• Experience leading cross-functional teams, driving alignment, accountability, and execution across multiple functions.
• Experience in clinical trial safety assessment; safety physician/medical monitor preferred for MD candidates.
• Excellent communication and presentation skills; proficient in Microsoft Office.

Responsibilities

• Provide clinical and scientific leadership for neuropsychiatric programs, including program development, clinical trial execution, data interpretation, and regulatory submissions; when medically qualified, serve as safety physician and medical monitor.
• Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports, with a focus on studies capable of supporting regulatory decisions.
• Lead clinical development plans and overall strategy for compounds or indications in neuropsychiatry, with particular attention to psychiatric disorders.
• Collaborate with pre-clinical and translational sciences, and senior management in assessing requirements for emerging products or business development opportunities.
• Provide leadership on cross-functional product development team(s).
• Participate in identification, selection and conduct of negotiations with clinical research sites and investigators.
• Participate in the selection and management activities of CROs.
• Lead and mentor project team members in planning, conducting, analyzing, and evaluating clinical trials.
• Oversee planning and management of investigator meetings, advisory boards and other scientific committees.
• Drive fiscal responsibility with the operational budget and cost savings initiatives.
• Maintain compliance with SOPs and policies and perform all duties consistent with GCP.
• Performs other related duties as assigned by management.

Skills

Leadership

Cross-functional teams

Regulatory submissions

GCP knowledge

Scientific writing

Medical monitoring

Education

PhD/MD/PharmD

Tools

Microsoft Office Suite

Job description

Harmony Biosciences is seeking an Executive Director, Clinical Development Neuropsychiatry Franchise Lead to drive program strategy and clinical execution in the Plymouth Meeting office. This senior role leads cross-functional teams, oversees trial design, data interpretation, regulatory submissions, and safety considerations for neuropsychiatry programs.

The ideal candidate has an advanced degree and 12+ years of pharma/biotech experience, with a strong record in NDA submissions, leadership