Harmony Biosciences is recruiting for an Executive Director, Clinical Development Neuropsychiatry Franchise Lead in our Plymouth Meeting office. This role leads the clinical development strategy and execution for the neuropsychiatric programs at Harmony Biosciences. This role requires deep expertise in psychiatry to provide scientific and clinical leadership across study design, conduct, interpretation, and regulatory submissions, including New Drug Applications (NDAs). The Executive Director partners with Clinical Operations and cross-functional teams to deliver high-quality studies and advance development programs.
Responsibilities include but are not limited to:- 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 of 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.
SUPERVISORY RESPONSIBILITIES: - Leads and mentors cross-functional project teams; direct supervisory responsibilities may be assigned based on organizational needs.
Qualifications:- Advanced degree required, PhD, MD or PharmD is strongly preferred; proven expertise in psychiatry and neuropsychiatric clinical development required
- 12+ years clinical development experience within a pharmaceutical, biotechnology, or CRO organization, including leadership of clinical programs; knowledge of GCP is required
- Demonstrated track record of leading positive clinical studies and contributing to NDA submissions, including clinical strategy, study reports, or submission documents
- Demonstrated experience leading cross-functional teams, driving alignment, accountability, and execution across multiple functions to achieve strategic business objectives.
- Experience in clinical trial safety assessment and interpretation required; experience serving as a safety physician or medical monitor is preferred for MD candidates
- Strong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures
- Excellent presentation skills to include oral and written communication skills
- Proficient in the use of Microsoft Office Suite
Physical demands and work environment:- Travel (both domestic and international) is estimated to be 15% of the time for this position; Candidate must be able to maintain or obtain valid US Passport within 90 days of hire date
- While performing the duties of this job, the noise level in the work environment is usually quiet.
- Specific vision abilities required by this job include: Close vision.
- Manual dexterity required to use computers, tablets, and cell phone.
- Continuous sitting for prolonged periods.
What can Harmony offer you?- Medical, Vision and Dental benefits the first of the month following start date
- Generous paid time off and Company designated Holidays
- Company paid Disability benefits and Life Insurance coverage
- 401(k) Retirement Savings Plan
- Paid Parental leave
- Employee Stock Purchase Plan (ESPP)
- Company sponsored wellness programs
- Professional development initiatives and continuous learning opportunities
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