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Medical Director, Clinical Development
3 months ago
In this role you will be responsible for leading and driving input into clinical development strategy for key programs and studies for Harmony Biosciences.
This role will serve as the medical lead on Harmony's Epilepsy programs as well as the sponsor's safety physician for these programs.
This role will work very closely with Harmony's Clinical Operations team and partner with the lead Clinical Trial Manager and the CRO 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 medical and clinical strategy lead for clinical programs and studies.
Operate as a subject matter expert for an indication franchise/pilar of clinical development in Harmony Biosciences.
Provide medical oversight 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 leading/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 preclinical and translational scientists, 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.
Perform other related duties as assigned by management.
Supervisory Responsibilities:
This position currently has no supervisory responsibilities but may offer this opportunity as the company grows.
Qualifications:
MD:
Board certified in Neurology and fellowship in Epilepsy is required.
3+ years of experience in a medical lead / safety physician role in academia/CRO/pharma/biotech organization; if only academic 3+ years of experience, clinical trial experience is a must.
Experience working in a medical lead / safety physician role with demonstrated knowledge of review of safety cases and drafting of clinical narratives.
Understanding of and experience with most functions involved in clinical development programs, including program management, clinical operations, biostatistics, pharmacovigilance, medical writing, regulatory and medical affairs.
Strong verbal and written communication/presentation skills with the ability to address colleagues, business partners, stakeholders and upper management across varied styles and cultures.
High ethical & quality standards demonstrated through actions and communication.Demonstrated ability to function independently and seek guidance, as needed.
Demonstrated ability to identify opportunities for continual improvement with a proven track record as a proficient solver of complex problems.
Strong computer, organizational, and analytical skills required.Must think critically and creatively and be able to determine appropriate resources for resolution of problems and have strong organizational and planning skills.
Demonstrated experience working within a fast-paced, matrixed environment.Physical demands and work environment:
Travel is estimated to be 20% of the time for this position.
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 six 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, visitHarmony Biosciences, LLC 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.
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