Associate Director, Clinical Operations

Harmony Biosciences is recruiting for an Associate Director, Clinical Operations in our Plymouth Meeting location. In this role you will be responsible for leading the end-to-end execution of clinical trials, including protocol development, vendor selection, study start-up, conduct, and close-out, ensuring high-quality delivery and adherence to timelines. Oversees the development and review of key study documentation while providing guidance to team members and maintaining strong collaboration with CROs, vendors, and cross-functional partners. Drives strategic planning, risk mitigation, and operational efficiency, including budget management, KPI tracking, and continuous process improvement. Partners closely with senior leadership and medical experts to align clinical development plans with business objectives, regulatory requirements, and overall company strategy.

Responsibilities include but are not limited to:

• Responsible for the oversight of trial-level operations for existing and/or future clinical studies, including but not limited to protocol concept design, CRO and vendor selection, CRO oversight, investigator meetings, etc.
• Oversee clinical trial conduct including study start-up, enrollment, study conduct and close-out.
• Prepares and/or reviews study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters). Provides oversight and guidance if some tasks are delegated to a Clinical Trials Specialist.
• Ongoing oversight of collaboration partners, including setting study goals, team training, development of trial budgets and implementation of a financial reconciliation process for clinical studies.
• Identify ways to accelerate the project execution where possible while maintaining high quality standards.
• Provides contingencies and alternate approaches to Senior Management
• Understands and applies overall business objectives and company strategy.
• Responsible for facilitation of effective internal and external departmental relationships, efficient group functionality, new process and method evaluation, and achievement of clinical research department goals.
• Responsible for managing the strategy, design, development, and evaluation of the clinical plans and expediting the implementation of related clinical trials for the purpose of regulatory filing, obtaining outcomes data, and marketing efforts.
• Coordinates closely with cross-functional leaders (medical affairs, compliance, regulatory, etc.) to ensure optimal alignment of commercial goals, site operations, data monitoring and review, and safety surveillance and reporting.
• Interacts regularly with senior management and key medical opinion leaders in the synthesis of clinical development plans and clinical research strategies.
• Establishes and administers KPIs to ensure customer and company business needs are consistently achieved and provide timely information to executive management team to drive effective business strategies

Qualifications:

• Bachelor's degree required; Master's degree is preferred
• 8+ years of experience required in clinical research in the pharmaceutical/research industry leading complex clinical research deliverables in a multi-disciplinary, cross-functional environment
• Experience in more than one therapeutic area is required
• Working knowledge of legal, compliance, and regulatory guidelines related to conduct of late-phase trials in the US and globally
• Analytical skills, quick perception and excellent judgment; able to identify risks and problems, to develop adequate problem-solving strategies even in complex situations, and to take appropriate measures when required.
• Considers quality and attention to detail as fundamental and necessary attributes of all output and patient safety as an overarching responsibility
• Strategic problem-solver with ability to identify appropriate solutions
• Effective written and verbal communication skills
• Proficient in the use of Microsoft Office Suite

Physical demands and work environment:

• Travel (both domestic and international) is estimated to be 25% 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 requires use of 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.

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