Job Overview
Compensation
Salary
Range $196,000.00 - $294,000.00
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life insurance
401(k) matching
Paid Time Off
equity participation
Job Description
Rocket Pharma is a fully integrated, late-stage biotechnology company dedicated to advancing gene therapies with curative potential for patients suffering from rare and life-threatening diseases. Founded on a foundation of innovation and compassion, Rocket Pharma is a dynamic and rapidly growing company that fosters a collaborative and inclusive environment where creativity and bold ideas are championed. The company places tremendous value on its employees, offering a supportive workplace culture energized by a shared mission: to change the future of medicine by developing transformative gene therapies. Rocket Pharma’s team of driven, compassionate, and knowledgeable professionals work together to push the boundaries of science and medicine, emphasizing trust, generosity toward patients, curiosity, and constant scientific elevation.
The position of Director, Clinical Operations – AAV, plays a pivotal role within Rocket Pharma’s clinical development landscape. Reporting directly to the Vice President of Clinical Operations, this leadership role is responsible for the strategic oversight and operational execution of clinical programs focused on adeno-associated virus (AAV) gene therapies within the company’s portfolio. The director will oversee the planning, initiation, continuous supervision, and completion of clinical research studies centered on rare genetic diseases. This includes managing critical timelines, adhering to budgets, supervising clinical trial sites, coordinating with vendors, and ensuring deliverables meet the highest standards for quality and regulatory compliance throughout the trial process.
The Director of Clinical Operations will act as the primary liaison between clinical vendors, trial sites, and various internal and external stakeholders. The role requires strong leadership capabilities to drive collaboration across cross-functional teams, employing strategic and critical thinking skills to prioritize and ensure smooth clinical operations that align with Good Clinical Practices (GCP) and all relevant regulations. Additionally, the individual will mentor and guide clinical operations team members, fostering professional development and multi-functional collaboration to achieve successful clinical outcomes.
This position offers a competitive salary range between $196,000 and $261,000, complemented by a comprehensive benefits package including equity participation, 401(k) matching, excellent health coverage, paid time off, and wellness resources. Rocket Pharma embraces an at-will employment policy for U.S.-based candidates and is committed to equity in compensation reflecting the responsibilities of the role, experience levels, position location, and competitive market factors. Overall, this role represents a unique opportunity to contribute to groundbreaking clinical research aimed at transforming the lives of patients with rare diseases by harnessing the power of gene therapy.
The position of Director, Clinical Operations – AAV, plays a pivotal role within Rocket Pharma’s clinical development landscape. Reporting directly to the Vice President of Clinical Operations, this leadership role is responsible for the strategic oversight and operational execution of clinical programs focused on adeno-associated virus (AAV) gene therapies within the company’s portfolio. The director will oversee the planning, initiation, continuous supervision, and completion of clinical research studies centered on rare genetic diseases. This includes managing critical timelines, adhering to budgets, supervising clinical trial sites, coordinating with vendors, and ensuring deliverables meet the highest standards for quality and regulatory compliance throughout the trial process.
The Director of Clinical Operations will act as the primary liaison between clinical vendors, trial sites, and various internal and external stakeholders. The role requires strong leadership capabilities to drive collaboration across cross-functional teams, employing strategic and critical thinking skills to prioritize and ensure smooth clinical operations that align with Good Clinical Practices (GCP) and all relevant regulations. Additionally, the individual will mentor and guide clinical operations team members, fostering professional development and multi-functional collaboration to achieve successful clinical outcomes.
This position offers a competitive salary range between $196,000 and $261,000, complemented by a comprehensive benefits package including equity participation, 401(k) matching, excellent health coverage, paid time off, and wellness resources. Rocket Pharma embraces an at-will employment policy for U.S.-based candidates and is committed to equity in compensation reflecting the responsibilities of the role, experience levels, position location, and competitive market factors. Overall, this role represents a unique opportunity to contribute to groundbreaking clinical research aimed at transforming the lives of patients with rare diseases by harnessing the power of gene therapy.
Job Requirements
- Bachelor’s degree in health care, life sciences, or related field
- minimum 12 years clinical trial experience in pharmaceutical, biotech, or clinical research organization
- at least 8 years managing clinical trial programs in a global setting
- proven leadership managing clinical trial teams
- experience with gene therapy or rare disease clinical trials preferred
- knowledge of regulatory requirements and filings
- strong project management expertise
- experience creating SOPs and clinical guidelines
- excellent interpersonal and communication skills
- prior experience with clinical trial management software preferred
- proficiency with MS Office and collaboration tools
- ability and willingness to travel 10-20%
Job Qualifications
- Bachelor’s degree preferably in health care or life sciences or related field
- 12 years of relevant clinical trial experience in pharmaceutical/biotech industry or clinical research organizations
- at least 8 years managing clinical trial programs including vendor management in a global environment
- experience managing Clinical Trial Manager and Clinical Research Associate teams
- experience in gene therapy, rare or orphan disease preferred
- knowledge of regulatory filings such as NDA, BLA, MAA and health authority inspections highly desired
- thorough knowledge of Clinical Development process and global regulatory compliance including ICH/GCP and 21 CFR
- in-depth knowledge of clinical operations and site management across all clinical trial phases
- advanced project management skills in schedule, budget, communication, and quality
- experience in developing SOPs and clinical procedures
- proven ability to develop effective relationships with stakeholders and lead cross-functional teams
- prior experience with Medidata RAVE, Veeva CTMS, eTMF, and QMS preferred
- proficiency in MS Office and SharePoint
- experience working internationally
- ability to travel 10-20%
Job Duties
- Serves as Clinical Operations single point of accountability in AAV Global Program Teams (GPTs)
- provides overall operational and strategic input during clinical trials planning and execution
- oversees and directs team members for clinical monitoring and site activities ensuring GCP compliance
- manages clinical monitoring activities including site qualification, initiation, interim monitoring, and closeout visits
- oversees monitoring trip reports and resolution of CRO action items
- informs AAV leadership on clinical trial status and issues
- manages Clinical Vendors including CROs, labs, and imaging vendors, overseeing contracts and budgets
- develops communication pathways for trial logistics and site communication
- directs cross-functional Study Operations teams and manages meetings
- oversees quality review and reconciliation of study documents
- supports Clinical Operations leadership in process improvement and mentoring
- leads team efforts in clinical data review and accuracy
- ensures study teams have appropriate management tools
- collaborates with CQA for GCP/GPV inspection readiness and audit follow-up
- represents Clinical Operations in Regulatory Agency inspections
Job Criteria
Experience
Expert Level (7+ years)
Job Location
Your Profile Is Visible To Hiring Managers Across OysterLink.
We'll match you with best jobs
Get job offers faster


Search For More Opportunities:
How Candidates Get Hired Faster
Apply to 2–3 similar roles
Complete profile & get best matches
Check new opportunities daily

