Associate Director, Clinical Operations

Advanced Recruiting Partners; United States; On-site; USD 165,000 - 195,000; Full time

Job summary

Join a forward-thinking organization as an Associate Director in Program Management, where you'll play a pivotal role in the R&D sector. This position offers the opportunity to collaborate closely with Clinical Operations, ensuring effective communication and program tracking for groundbreaking gene therapy initiatives. Your exceptional organizational and communication skills will be key in fostering a motivating environment that drives team success. If you're ready to make a significant impact in a dynamic and innovative setting, this role is perfect for you.

Qualifications

• Minimum 8 years in pharma/biotech with 5 years in program management.
• Experience with regulatory filings and clinical trial applications.
• Strong organizational and project management skills.

Responsibilities

• Collaborate with Clinical Operations to drive deliverables.
• Provide clear direction on program requirements and track progress.
• Lead meetings to encourage collaboration and drive decisions.

Skills

Program Management

Clinical Operations

Regulatory Filings

Project Management

Communication Skills

Problem-Solving

Interpersonal Skills

Education

Bachelor’s degree in life sciences

Tools

MS Office

Smartsheet

Job description

The Associate Director (AD), Program Management, is responsible for providing program management support within the R&D organization and ensuring effective communication between the company and its partners (e.g., CROs, etc.). This role will closely collaborate with the Clinical Operations team to facilitate program tracking (e.g., timelines, risks, actions, and financials, as needed), decision-making, and planning in support of the lead gene therapy program. To succeed in this position, the candidate must be able to communicate clear direction (both verbally and in writing) and demonstrate exceptional organizational skills. Additionally, the ideal candidate will foster a motivating and engaging environment where the team collaborates effectively within their own team and across functions to achieve outstanding results and ensure long-term success.

• Collaborate with the Clinical Operations team to drive the completion of deliverables
• Partner with the PMO organization to develop short- and long-term management plans, track progress against these plans, and communicate timely, accurate status updates both formally and informally.
• Provide clear direction on program requirements to meet stakeholder expectations and establish and/or utilize tools for tracking and reporting activities, milestones, and risks. Escalate critical risks and decisions needed by senior management to keep the plans on track.
• Lead functional and cross-functional meetings to encourage collaborative dialogue, support the completion of deliverables, and drive decisions. Manage meeting agendas and minutes.
• Encourage collaboration between scientific and operational teams.
• Work with the Clinical Operations team to establish annual functional goals and report progress at least quarterly.
• Assist in identifying and evaluating external vendors and coordinate communication during the bidding and/or contracting process as needed.
• Contribute to the development and improvement of business processes, tools, and templates related to program management best practices.

Skills & Education Requirements

• Bachelor’s degree in life sciences with a minimum of 8 years of experience in the pharmaceutical, biotech, or life sciences industries.
• At least 5 years of experience in program management.
• Experience working with or partnering with Clinical Operations and/or gene therapy experience is preferred.
• Proven track record in regulatory filings for clinical trial applications (e.g., IND) and marketing approvals (e.g., NDA, BLA, MAA).
• Strong organizational, project, and time management skills, with a demonstrated ability to manage multiple projects and priorities simultaneously.
• Excellent communication skills, both written and verbal.
• Solutions-oriented with strong problem-solving capabilities.
• Proven ability to deliver results in a fast-paced, innovative, and dynamic environment while remaining flexible, proactive, and efficient.
• Strong interpersonal and relationship-building skills, with the ability to influence, negotiate, resolve conflict, and drive consensus across diverse individuals and teams.
• Demonstrated experience coordinating interdisciplinary teams and working with external vendors.
• Proficiency in MS Office programs and Smartsheet.
• A strong alignment with the company’s core values of Integrity, Accountability, and Teamwork.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Staffing and Recruiting

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