Associate Director, Clinical Operations

PTC Therapeutics - Warren, NJ

Full-time - Mid Level

Warren, NJ

Chemical Manufacturing

About the position

The Associate Director, Clinical Operations provides the scientific and operational expertise required to lead the execution of the complete life cycle of clinical trials in accordance with appropriate regulatory requirements for one or more indications within or across therapeutic areas. The incumbent works as an integrated member of the clinical team to manage clinical trial(s) from study design through close out. This role involves significant collaboration with internal departments and external resources to address Clinical Operations related issues, ensuring adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs).

Responsibilities

• Lead, direct and contribute to the planning, execution, and reporting of clinical trials, including estimation of clinical project timelines, protocol writing, Case Report Form (CRF) design, site selection, study drug forecasting, site and Clinical Research Organization (CRO) management, data review, and study reporting.
• Interact with external and internal project team members to assist in the development of clinical strategies, trial design, study plans, and project deliverables; meet with investigators and PTC scientific and clinical staff to obtain direction and feedback.
• Assist in the evaluation of scientific literature and investigator advice regarding current clinical practice as a component of clinical strategy and protocol development; write, review and/or edit study protocols, protocol amendments, study manuals, informed consent forms, and related documents.
• Prepare investigational site lists and participate in the review and approval of investigational sites; negotiate contracts and budgets with sites and vendors and present to the project team for approval; plan, coordinate, and conduct investigator meetings including presentations at the meetings; respond to questions from sites and trial monitors regarding trial conduct.
• Manage clinical study timelines using appropriate project management tools; develop budgets and manage expenditures for clinical trial program, including those for investigational sites and vendors; present project progress reports through accurate, succinct summaries of clinical study work at internal team meetings and investigator meetings.
• Facilitate regulatory submissions and communications by working with appropriate team members during the submission process; write assigned portions of reports for submission to regulatory agencies, institutional review boards, scientific journals, and conferences.
• Provide ongoing review of clinical trial data to ensure timely, consistent, and accurate data; assist in the interpretation of clinical data in preparation for clinical study reports and regulatory submissions.
• Manage, coach and mentor direct reports.

Requirements

• Bachelor's degree in a scientific discipline and a minimum of 7 years progressively responsible US and/or global experience in clinical research in a pharmaceutical, biotechnology, CRO, university medical center or related environment.
• Comprehensive working knowledge of the drug developmental process.
• Working knowledge of clinical trial design, conduct, data acquisition, and reporting.
• Ability to recognize safety and efficacy trends of clinical data.
• Hands-on experience supporting and understanding Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and International Conference on Harmonisation (ICH) guidelines.
• Ability to influence without direct authority.
• Proficiency with Microsoft Word and Excel.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Nice-to-haves

• Prior involvement in Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions.
• Previous experience as a field monitor.
• Medical writing experience or training.
• Proficiency with Microsoft Project and Powerpoint.
• People and project management experience.