Associate Director, Clinical Operations

PTC Therapeutics, Inc.; New Jersey; On-site; USD 170,000 - 214,000; Full time

Benefits offered by this job

Short- and long-term incentives

Medical, dental, vision

Retirement savings plan

Job summary

PTC Therapeutics, Inc. seeks an Associate Director, Clinical Operations to lead the end‑to‑end life cycle of clinical trials across indications. You will manage study design, timelines, site selection, budgeting and data review as part of a cross‑functional team.

In this role, you will collaborate with investigators and internal stakeholders, drive regulatory submissions, and oversee mentor-mentee relationships. A strong GMP/GCP/ICH background and excellent communication are essential.

Qualifications

• Bachelor’s degree in a scientific discipline and a minimum of 7 years progressively responsible US and/or global experience in clinical research.
• Experience with protocol development, CRF design, site selection and budgeting.
• Familiarity with GMP, GCP and ICH guidelines; ability to interpret clinical data.

Responsibilities

• Lead, direct and contribute to planning, execution, and reporting of clinical trials, including timelines, protocol writing, site management, drug forecasting, and data review.
• Interact with internal and external team members to develop clinical strategies and study plans.
• Prepare and edit study protocols, amendments, manuals, informed consent forms, and associated documents.
• Manage investigation sites, budgets, contracts, and investigator meetings; respond to site questions.
• Manage study timelines and budgets; present progress at team and investigator meetings.
• Support regulatory submissions and communications; contribute to reports for agencies and journals.
• Mentor and guide direct reports; travel up to 20% as needed.

Skills

Clinical operations

Project management

Regulatory understanding

Data review and reporting

Communication skills

GMP/GCP/ICH knowledge

Mentoring

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

PowerPoint

Job description

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!

Site: www.ptcbio.com

Job Description Summary

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.

The Associate Director, Clinical Operations may manage direct report(s).

The incumbent works cross-functionally with internal departments and external resources on Clinical Operations related issues.

The Associate Director, Clinical Operations supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Description

ESSENTIAL FUNCTIONS

Primary Duties/responsibilities

• Performs as an integrated member of the clinical team to 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; recommends monitoring, safety, eligibility, enrollment, and data consistency strategies.
• Interacts with external and internal project team members to assist in the development of clinical strategies, trial design, study plans, and project deliverables; meets with investigators and PTC scientific and clinical staff to obtain direction and feedback.
• Assists in the evaluation of scientific literature and investigator advice regarding current clinical practice as a component of clinical strategy and protocol development; writes, reviews and/or edits study protocols, protocol amendments, study manuals, informed consent forms, and related documents.
• Prepares investigational site lists and participates in the review and approval of investigational sites; negotiates contracts and budgets with sites and vendors and presents to the project team for approval; plans, coordinates, and conducts investigator meetings including presentations at the meetings; responds to questions from sites and trial monitors regarding trial conduct.
• Manages clinical study timelines using the appropriate project management tools; develops budgets and manages expenditures for clinical trial program, including those for investigational sites and vendors; presents project progress reports through accurate, succinct summaries of clinical study work at internal team meetings and investigator meetings.
• Facilitates regulatory submissions and communications by working with appropriate team members during the submission process; writes assigned portions of reports for submission to regulatory agencies, institutional review boards, scientific journals, and conferences.
• Provides on-going review of clinical trial data to ensure timely, consistent, and accurate data; assists in the interpretation of clinical data in preparation for clinical study reports and regulatory submissions.
• Manages, coaches and mentors direct reports.

Knowledge/Skills/Abilities Required

• Minimum level of education and years of relevant work experience.
• 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.
• Special knowledge or skills needed and/or licenses or certificates required.
• 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 and skills.
• Ability to work independently and collaboratively, as required, 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.
• Special knowledge or skills and/or licenses or certificates preferred.
• 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.
• Travel requirements
• Up to 20%

Expected Base Salary Range: $170,200 - $214,200.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.

EEO Statement

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.