Senior Director, Clinical Pharmacology

Harmony Biosciences is recruiting for a Senior Director, Clinical Pharmacology in our Plymouth Meeting, PA location. In this role you will lead the planning, development and conduct of clinical pharmacology and pharmacometrics studies and provide the overall strategy to support the full Harmony Biosciences portfolio.

Responsibilities include but are not limited to:

• Propose, communicate and implement an overall clinical pharmacology and pharmacometrics strategy to support all stages of drug development.
• Lead clinical pharmacology activities in cross- functional settings, effectively collaborating and interacting with other functions to ensure strategic alignment across related functions.
• Provide guidance on and completion of protocol, IB, SAP, regulatory documents, and study reports to support clinical pharmacology plans and studies; responsible for all clinical pharmacology delivery timelines.
• Manage dedicated clinical pharmacology studies by selecting and working closely with suitable vendors, manage vendor operations and provide technical input to ensure trial success.
• Lead clinical pharmacology regulatory document authoring, submission and responses to agency's information requests and comments.
• Build and maintain a state of the clinical pharmacology function, and apply the most effective approaches in clinical development and strategy based on individual project needs.
• Plan and manage infrastructure, budget, and team building for clinical pharmacology.

Supervisory Responsibilities:

• The position carries out supervisory responsibilities of clinical pharmacology and pharmacometrics consultants and/or contactors in accordance with the organization's policies and applicable laws.
• Reflecting the growth potential of the position, supervisory responsibilities may expand to full time employees
• Interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Qualifications:

• PhD or PharmD required
• 10+ years pharmaceutical industry experience in clinical pharmacology with expertise in one or more areas of clinical pharmacology, pharmacometrics, or preclinical and human ADME studies.
• Experienced in having a leading clinical pharmacology role in supporting clinical development activities from pre-IND to IND and NDA submissions and filings based on interactions with regulatory authorities.
• Proved tracking record of scientific publications in clinical pharmacology, human ADME and pharmacometrics.
• Strong knowledge of modeling and approaches, and experience with related platforms, e.g., Phoenix WinNonlin and NONMEM.
• Good project management skills, e.g., in scope proposal and management, progress tracking and driving, and time management.
• Familiar and understanding of clinical pharmacology related guidance documents. Can effectively implement into the drug development process.
• Ability to work independently as well as collaboratively with other related functions such as regulatory, clinical science, clinical operations, CMC etc.
• Ability to clearly articulate clinical pharmacology development strategies, plans, and results in regulatory settings and internal cross functional settings, influencing decision making.
• Ability to work well with internal teams, external vendors, collaborators, and agencies with professionalism and integrity.

Physical demands and work environment:

• Domestic travel is estimated to be up to 20% 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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