Director, Clinical Operations - AAV

Rocket Pharmaceuticals•Cranbury, NJ

2d•$196,000 - $261,000•Onsite

About The Position

The Director, Clinical Operations – AAV, reporting to the VP, Clinical Operations, is responsible for strategic oversight & operational execution of the Clinical Operations function within the AAV programs in the Rocket portfolio, specifically the aspects of planning, initiating, ongoing supervision, and completion of clinical research studies for several rare genetic diseases. Responsibilities include the oversight of managing timelines, budgets, clinical sites, vendors, and deliverables while maintaining quality and regulatory compliance. This role will also be responsible for being the liaison with clinical vendors, clinical sites, and a wide range of internal & external company stakeholders. 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. The candidate will also act as a mentor to members of the Clinical Operations & wider Clinical Development organization to utilize expertise and promote collaboration cross functionally to ensure successful outcomes.

Requirements

Bachelor’s degree preferably in health care or life sciences or other related field of study
12 years of relevant clinical trial experience in the pharmaceutical/biotech industry, clinical research organizations and/or clinical research experience in a healthcare setting
At least 8 years of direct experience in managing clinical trial programs (start-up through close-out) including vendor management, preferably in a global environment.
Experience in managing teams of Clinical Trial Manager and Clinical Research Associates
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.
In-depth knowledge regarding all clinical operations and site management/monitoring activities across all phases of clinical trials.
Advanced skills in Project Management, particularly regarding management of schedule, budget, communication, resources, and quality
Demonstrated experience in developing SOPs, procedures, policies & Work Instructions across various Clinical Development functional areas.
History of successfully developing effective relationships with internal & external key stakeholders and the ability to effectively lead cross-functional teams in a matrix environment with a professional demeanor.
Proficient in MS Office tools (Excel, Word, PowerPoint, Outlook & Teams), SharePoint.
Experience working in a global environment
Ability to travel approximately 10-20%

Nice To Haves

Experience in gene therapy, rare/orphan disease highly desired.
Experience in regulatory filings (e.g., NDA, BLA, MAA) & health authority inspections highly desired.
Previous experience with Medidata RAVE & Veeva CTMS, eTMF & QMS highly desired.

Responsibilities

Serves as Clinical Operations single point of accountability in AAV Global Program Teams (GPTs); accountable for Clinical Operations strategy, execution of deliverables within designated study budgets/timelines/quality standards, sharing risks & opportunities, collaborating & communicating with Team Members and GPH/PM
Provides overall operational and strategic input during the planning and execution of clinical trials that include, but are not limited to: clinical planning tools, protocol review, case report form (CRF) development and review, clinical trial-related operational manuals, oversight of study-specific eTMF plans, training materials, and various clinical trial plans (e.g., monitoring, risk mitigation, communication, etc. plans) and budget planning.
Oversees and directs other team members on clinical monitoring and site activities to ensure compliance with Good Clinical Practices (GCP) and applicable regulations.
Oversees clinical monitoring (site qualification, site initiation, interim monitoring, clinical trial closeout visits) to ensure the integrity, accuracy, and accountability of clinical data. May participate in on-site visits as needed or accompany junior team members for training purposes.
Oversees monitoring trip reports process and ensures resolution of all action items related to CROs.
Informs the AAV leadership team and Head of Clinical Operations, on the overall clinical trial status and potential issues/mitigation.
Provides management and oversight of Clinical Vendors associated with assigned studies (i.e., CROs, Central & Specialty Labs, Imaging vendors, etc.) Ensures that vendors comply with all required standards and raises any issues and/or concerns. Oversees RFP process, contract and budget preparation, negotiations, and management throughout the trial life cycle.
Develops communication pathways and study-specific processes to allow team members to communicate with clinical trial sites regarding all logistics including contract agreements, support materials and training, and IRB/EC application process.
Direct oversight of cross-functional Study Operations teams Ensures that study information is disseminated to the appropriate stakeholders. Oversees and manages other meetings to include internal team meetings, investigator meetings, and other trial-specific meetings.
Oversees ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages. Develops and oversees clinical site budgets, investigator and vendor payment processes and invoices related to projects assigned.
As a member of the Clinical Operations Leadership Team, supports the Head of Clinical Operations in initiatives to streamline and improve processes, SOP development, mentoring and developing Clinical Trial Managers & Clinical Research Associates
Leads cross-functional team efforts on review of clinical data listings (protocol deviations, study data review, etc.) for completeness and accuracy and escalate issues as needed.
Ensures that internal study teams and clinical sites have the appropriate study management tools to execute the study.
Collaborate with CQA in ensuring GCP/GPV inspection readiness of the organization, its vendors, and its clinical investigators/sites, and subsequently managing follow-up within the Clinical Development organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)
Provides representation for the Clinical Operations organization in Regulatory Agency inspections.