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Associate Director, Clinical Operations
PTC Therapeutics, Inc.Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading clinical trials, including protocol development, project management, and regulatory submissions. Proficient in analyzing clinical data and ensuring compliance with GMP, GCP, and ICH guidelines while effectively collaborating with diverse teams.
Highest-signal resume keywords
Clinical Trial ManagementProtocol DevelopmentRegulatory SubmissionsData AnalysisProject Management
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Lead, direct, and contribute to planning, execution, and reporting of clinical trials
- Estimate clinical project timelines and develop protocols and Case Report Forms
- Select and manage investigational sites and Clinical Research Organizations
- Forecast study drug requirements and recommend monitoring, safety, eligibility, enrollment, and data consistency strategies
- Collaborate with internal and external project team members on clinical strategies, trial design, study plans, and deliverables
- Evaluate scientific literature and investigator advice to support clinical strategy and protocol development
- Write, review, and edit protocols, amendments, study manuals, informed consent forms, and related documents
- Prepare investigational site lists and participate in site review and approval
- Negotiate site and vendor contracts and budgets
- Plan, coordinate, and conduct investigator meetings, including presentations
- Respond to site and trial monitor questions regarding trial conduct
- Manage clinical study timelines, budgets, and expenditures
- Present project progress reports at internal and investigator meetings
- Facilitate regulatory submissions and communications
- Write assigned portions of reports for regulatory agencies, institutional review boards, journals, and conferences
- Review clinical trial data for timely, consistent, and accurate data
- Assist with interpretation of clinical data for clinical study reports and regulatory submissions
- Manage, coach, and mentor direct reports
Requirements
What you’ll need- Bachelor’s degree in a scientific discipline
- 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 GMP, GCP, and 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
- Analytical thinking and excellent problem-solving skills
- Excellent planning, organization, and time management skills
- Preferred: prior involvement in INDs and NDAs submissions
- Preferred: previous experience as a field monitor
- Preferred: medical writing experience or training
- Preferred: proficiency with Microsoft Project and PowerPoint
- Preferred: people and project management experience
- Up to 20% travel
Benefits
Comp & perks- Short- and long-term incentives
- Medical plan
- Dental plan
- Vision plan
- Retirement savings plan
- Equal opportunity employment
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial DesignData AcquisitionGMP KnowledgeGCP KnowledgeICH GuidelinesAnalytical ThinkingProblem-SolvingMedical WritingBudget ManagementTimeline Management
Soft Skills
Excellent Communication SkillsInfluencing Without AuthorityCollaborationPlanning and OrganizationTime Management
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft ProjectMicrosoft PowerPoint
Industry Keywords
Clinical ResearchPharmaceuticalBiotechnologyCROIND SubmissionsNDA SubmissionsInvestigator MeetingsSite ManagementClinical Data ReviewStudy Drug Requirements