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Associate Director, Clinical Process Management

3 months ago

Cranbury, United States Rocket Pharmaceuticals Full time

Overview Work at ROCKET PHARMA and help cure rare diseases

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

Position Summary The Associate Director, Clinical Process Management & Operational Excellence (reporting through the Senior Director, CQA) provides leadership and operational oversight of activities associated with clinical procedural development & maintenance, clinical training program management, inspection preparedness, and assessment & investigation of clinical quality compliance issues for the clinical and related functions in the R&D organization (i.e., Clinical Development, Clinical Operations, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Regulatory & RWE). The candidate will drive collaboration with the internal and external stakeholders on deliverables to ensure expected timelines, quality standards, Good Clinical Practices (GCP) and applicable regulations are being met throughout the Clinical Development Process. The candidate should be able to prioritize tasks, utilize strategic & critical thinking skills, and drive cross-functional teams with an emphasis on high quality outcomes.

Responsibilities · Partner with Functional & Executive Leadership to establish the vision and strategy for innovative and effective business processes and associated learning programs in support of clinical trial execution and in alignment with business vision, objectives & priorities.

· Lead the development and approval of controlled documents related to clinical study processes and systems including SOPs, Policies, SOPs, Work Instructions, forms and templates in compliance with global regulatory standards.

· Lead efforts with functional teams to create process flows to streamline processes and implement strategies to optimize workflow & productivity.

· Establish best practices in process ownership and development.

· Create standards for the development of procedural documents, including a detailed process overview, process for associated document management (e.g., glossary, curricula), and instructions for using electronic document repository.

· Provide leadership in continuous improvement of good clinical practices, regularly interacting with senior management or executive levels on matters concerning several functional areas.

· Lead the strategic development, implementation & execution of role-based curriculum and GCP training within the Clinical organization, and lead efforts on tracking & trending training compliance.

· Prepare/collect training documents in preparation for internal & external training file audits/inspections (e.g., completed SOP matrices, CVs, JDs etc.)

· Provide support for Regulatory Agency inspections, as necessary.

· Manage follow-up of procedural document and training aspects of Clinical Development related audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)

· Assist with management and oversight of the tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI), including reporting (if applicable) and ensure follow-up and closure.

· Support the completion of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities.

· Assist with oversight and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments

· Establish and assure adherence to budgets, schedules, work plans, and performance requirements.

· Point of contact for the clinical development organization and cross-functional stakeholders to manage concerns, provide ongoing guidance and clarify process requirements.

· Lead the escalation and communication of risks and issues associated with departmental processes as appropriate.

Qualifications Education/Experience and Skills Requirements:

· Bachelor’s degree required, preferably in health care or life sciences or other related field of study.

· Minimum 12 years of pharmaceutical/biotech industry and/or clinical research organization experience, with 8 years of direct experience in supporting global clinical programs with standards and compliance including health authority inspections (in either a Compliance, Quality, Clinical Operations, Training or Project Management function).

· Minimum of 6 years managing all aspects of clinical trial activities (start-up through close-out) including vendor management, preferably in a global environment.

· We encourage applicants with strong expertise in cell and gene therapy and rare disease, particularly those with Process Improvement backgrounds, to apply. This skill set may outweigh the requirement for a specific number of years of experience.

· Experience with Process Improvement methodologies (e.g., Six Sigma, Lean, Agile, etc.) highly desired.

· Experience in gene therapy, rare/orphan disease highly desired.

· Experience in regulatory filings (e.g., NDA, BLA, MAA) & health authority inspections highly desired.

Required Skills:

· Thorough, integrated knowledge and understanding of overall Clinical Development process & global regulatory and compliance requirements for clinical research, including

but not limited to ICH/GCP Guidelines, 21 CFR, and other applicable federal, local & international regulations.

· Demonstrated experience in developing SOPs, procedures, policies & Work Instructions across various Clinical Development functional areas.

· Experience in developing training and/or informational material and presenting to both internal and external stakeholders.

· Prior experience working on cross-functional teams in a lead capacity.

· History of successfully developing effective relationships with internal & external key stakeholders

· Ability to identify & troubleshoot issues, providing potential solutions and mitigation strategies.

· Experience working in a global environment.

Desired Competencies:

· Ability to adapt and prioritize competing demands within a dynamic environment.

· Outstanding organizational, time management, planning and record keeping skills.

· Advanced skills in Project Management, particularly regarding management of schedule, budget, communication, resources, and quality

· Advanced communication, presentation, interpersonal and negotiating skills.

· Ability to analyze, evaluate and prioritize key issues and problems, and subsequently seek-out and recommend possible solutions and mitigation strategies before escalation.

· Ability to effectively lead cross-functional teams in a matrix environment with a professional demeanor.

· Demonstrated strengths in conflict management & timely issue escalation.

· Ensure an enthusiastic and open attitude towards continuous professional development.

· Previous experience with Veeva CTMS, eTMF & QMS highly desired.

· Proficient in MS Office tools (Excel, Word, PowerPoint, Outlook & Teams), SharePoint.

Travel Requirements: Ability to travel approximately 10-20%

EEO Statement A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

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