Executive Director, Clinical Development Neuropsychiatry Lead

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Executive Director, Clinical Development Neuropsychiatry Lead

Full Time Management Plymouth Meeting Office, Plymouth Meeting, PA, US

Harmony Biosciences is recruiting for an Executive Director, Clinical Development Neuropsychiatry Franchise Lead in our Plymouth Meeting office.

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
• A certified Great Place to Work for eight consecutive years based on our positive, values-based company culture

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Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com

Harmony Biosciences is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.