Senior Director, Clinical Operations at PTC Therapeutics, Inc. in SOUTH PLAINFIELD, New Jersey

Job Description:

Job Description Summary:

The Senior 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 oversee clinical trials from study design through close out.

The Senior Director, Clinical Operations manages direct report(s)and provides overall leadership for clinical trial managers and their teams in a program setting.

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

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

Job Description:

• Hires, supervises, trains, and mentors clinical operations personnel, and helps set annual program goals, objectives and development plans for staff, provides performance feedback and conducts performance evaluations.


• As an integrated member of the clinical operations team leads, directs and actively contributes to the planning, execution, and reporting of clinical trials, including, but not limited to, estimation of clinical project timelines, Case Report Form (CRF) design, site and Clinical Research Organization (CRO) selection, study drug forecasting, site and CRO oversight and 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, PTC scientific and clinical staff, and as appropriate, Global Project Leaders to obtain/provide direction and feedback and to ensure teams are appropriately resourced.


• Assists in the evaluation of scientific literature and investigator advice regarding current clinical practice as a component of clinical strategy and protocol development; reviews study protocols, protocol amendments, study manuals, informed consent forms, and related documents.


• Manages and oversees clinical study timelines using the appropriate tools; contributes to study/site budget development 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 clinical operations team meetings.


• Facilitates regulatory submissions and communications by working with appropriate team members during the submission process; may review assigned portions of reports for submission to regulatory agencies, institutional review boards, scientific journals, and conferences.


• May provide on-going 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.


• Liaises with functional team members to agree on methods of work and lines of communication to improve processes.


• Supports the functional team members on matters related to the TMF.


• Maintains a positive culture and strong working relationships across organizational functions.


• Attends scientific conferences as needed.


• Manages, coaches and mentors direct reports.


• Performs other tasks and assignments as needed and specified by management. 

Qualifications:

• Bachelor’s degree in a relevant discipline and a minimum of 9 years of progressively responsible experience in global clinical development/clinical operations in a pharmaceutical, biotechnology, CRO, university medical center or related environment OR equivalent experience and/or education.

* Special knowledge or skills needed and/or licenses or certificates required.

• Demonstrated expertise of clinical operations, the clinical drug development process and clinical trial methodology.


• Ability to recognize safety and efficacy trends of clinical data.


• Demonstrated senior leadership ability in clinical operations and demonstrated experience managing, coaching and mentoring direct reports.


• 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), New Drug Applications (NDAs)  and/or BLA submissions.


• Proficiency with Microsoft Project and PowerPoint.

* Travel requirements: 10-20%

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.

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