Associate Director, Clinical Operations

About the role

The Associate Director, Clinical Operations will lead the end-to-end execution of clinical trials, oversee their conduct, and collaborate closely with senior leadership and medical experts to align clinical development plans with business objectives, regulatory requirements, and overall company strategy.

Responsibilities

• Oversee trial-level operations for existing and/or future clinical studies, including 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.
• Prepare and/or review 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).
• Provide 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.
• Facilitates effective internal and external departmental relationships, efficient group functionality, new process and method evaluation, and achievement of clinical research department goals.
• 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 Key Performance Indicators (KPIs) to ensure customer and company business needs are consistently achieved and provides 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
• Strategic problem-solver with ability to identify appropriate solutions
• Effective written and verbal communication skills
• Proficient in the use of Microsoft Office Suite

Benefits

• 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

What can Harmony offer you?

Harmony Biosciences offers a competitive compensation package, including medical, vision, and dental benefits, generous paid time off, and a variety of employee benefits such as disability insurance, life insurance, a 401(k) retirement savings plan, parental leave, and an Employee Stock Purchase Plan (ESPP). Additionally, we offer professional development initiatives and continuous learning opportunities, as well as a supportive and inclusive workplace culture.

How to apply

To apply for this position, please follow the instructions provided in the application link or email your resume and cover letter to [email protected]. We appreciate your interest in joining Harmony Biosciences.