Senior Medical Director, Clinical Development

Harmony Biosciences is recruiting for a Senior Medical Director, Clinical Development in our Plymouth Meeting, PA location. In this role you will be responsible for leading and driving input into clinical development strategy for key studies and programs for Harmony Biosciences. This role will serve as the sponsor's safety physician and medical monitor, responsible for review of all safety information and adjudication of expedited safety reporting. This role will work very closely with Harmony's Clinical Operations team and partner with the lead Clinical Trial Manager in the operational delivery of clinical studies. This position offers an exciting opportunity in a growing organization with multiple development programs to provide an impact from the start and then grow and advance as the company builds out its clinical development enterprise.

Responsibilities include but are not limited to:

• Serve as safety physician and medical monitor with primary responsibility for patient safety and conduct of assigned trials as well as overall data interpretation and safety surveillance.
• Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports.
• Responsible for assisting in design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds or indications in the areas of interest to Harmony Biosciences.
• Draft clinical trial protocols and lead cross-functional teams in the review and efficient finalization of clinical protocols and related clinical documents
• 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.
• Supervise project team members in planning, conducting, 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:

• This position has no supervisory responsibilities (but may offer this opportunity as the company grows)

Qualifications:

• MD required, BE/BC Neurologist with experience in Pediatric Epilepsy is preferred
• 5+ years of experience in a CRO/pharma/biotech organization; pharmaceutical experience is most preferred; Knowledge of GCP is required.
• 5+ years of CNS clinical research experience with ability to draft clinical development plans, clinical trial protocols and related clinical documents preferred
• Experience working in a safety physician role with demonstrated knowledge of review of safety cases and drafting of clinical narratives preferred
• 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:

• Global travel is estimated to be up to 25% of the time for this position.
• 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 seven 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.

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