Director, Gene Therapy Clinical Science

Rocket Pharmaceuticals, Inc.; Idaho; On-site; USD 206,000 - 248,000; Full time

Benefits offered by this job

Bonuses (short-term incentives)

Medical, dental, and vision insurance

Life insurance

401(k) with company match

Paid vacation and holidays

Global shutdown days

Wellness programs

Equity awards

Job summary

Rocket Pharma is seeking a dynamic Director, Gene Therapy Clinical Science to guide and execute clinical development strategies, lead First in Human programs through proof of concept, and ensure high-quality trial execution while upholding patient safety and scientific integrity.

You will collaborate with investigators and cross-functional teams, manage protocol development, data monitoring, and regulatory communications, and mentor clinical scientists to advance gene therapy efforts in a

Qualifications

• Nursing degree required; MSN or BSN with 10+ years of progressive experience in clinical research drug development preferably with cell or gene therapy in the pharma industry.
• Knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management and clinical data review is required.
• Excellent oral and written communication skills; ability to work cross-functionally in a dynamic environment.

Responsibilities

• Lead the clinical science team—assign resources and coach clinical scientists.
• Provide leadership and management of clinical studies, including planning, execution, completion, and reporting of trials.
• Oversee data review, safety monitoring, and preparation of clinical/regulatory documents.

Skills

Communication

Organizational skills

Detail-oriented

Leadership

Education

BSN

MSN

Job description

Overview

Create a future where DNA is no longer destiny. Join Rocket Pharma.

Rocket Pharma is a fully integrated, late-stage biotechnology company advancing gene therapies with curative potential for patients with rare and life-threatening diseases. We are a team of creative, compassionate, and driven individuals united by a profound mission of seeking gene therapy cures. Rocket places tremendous value on our people and fosters a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values guide everything we do: we trust one another, show generosity toward patients, embrace curiosity, and strive to elevate science. Team members receive a competitive total rewards package, including equity participation, 401(k) matching, and excellent health benefits.

Position Summary

Rocket Pharma is currently seeking a dynamic, and highly motivated Director, Gene Therapy Clinical Science. The candidate will support, guide and implement clinical development strategy and plans. Responsible for the timely execution of First in Human programs through proof of concept and delivery on clinical study designs, high quality trial execution, and preparation of clinical protocols. The candidate will be responsible for leading, developing, and managing clinical studies while building and maintaining relationships with investigators and key opinion leaders. In addition, candidate will be accountable for the medical & scientific integrity of the study and the wellbeing of the patients enrolled in one or more clinical trials. Maintains compliance with all internal and external standards, proactively mitigates risk and manages emerging clinical/medical issues in a timely manner. The position will report to the Associate Vice President, AAV Global Program Head.

Responsibilities

• Leading the clinical science team - responsible for assigning resources and coaching clinical scientists (with ability to delegate and guide).
• Provide leadership, oversight, and management of clinical studies including planning, execution, completion, and reporting of clinical trials.
• Provides clinical/medical input to support development of the protocol/ Informed Consent Form and Investigator Brochure. Leads development of protocol amendments, and other related documents.
• Provides clinical/medical input to the development of data collection tools, such as EDC database and other related tools, as applicable.
• Oversee the review and analysis of clinical data and the generation of study reports, publications, and clinical-regulatory documents.
• Oversee and conduct data review, analysis, and interpretation of clinical trials data
• Drafts and follows safety and data review plans to perform and document regular review of patient safety data and perform review of cumulative safety data
• Draft clinical and safety sections of critical documents
• Prepare and conduct presentations regarding strategy and/or data and support and assist in the development of publications, abstracts and presentations
• Partners with cross functional teams, such as basic research, translational science, clinical operations, regulatory affairs, manufacturing, medical affairs, project management etc as needed to ensure compliance with GCP and quality execution of plans that involve patient samples, analysis and clinical data
• Help with establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees. Oversee related charter development, committee presentations and documentation of outcomes.
• Serves as the key contact with external investigators and internal study team for questions relating to clinical/medical aspects of protocol.
• Represents the science function at key meetings, give scientific input at ad boards, congresses etc.
• Reviews, and manages protocol deviations.
• May support responsible colleagues with the development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs)
• Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.

Qualifications

• Nursing degree required. MSN and 10+ years, BSN and 12+ years of progressive experience in clinical research drug development preferably with cell or gene therapy in the pharma industry.
• Knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management and clinical data review is required.
• Must have ability to work collaboratively as part of a multi-functional drug development team in a dynamic environment.
• Must be self-motivated, highly organized, detail-oriented and able to multi-task, delivering high quality work.
• Excellent oral and written communication skills; excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally.

Compensation

The expected salary range for this position is $206,000 to $248,000.

At Rocket, our compensation philosophy and ranges are built upon data and insights collected from validated world-class providers. We are committed to compensating employees equitably based on several factors, including responsibilities and level of the position, depth and types of the employee’s experience, location of the position and availability of similar talent in a competitive market.

For U.S.-based candidates, this is an at-will position, and Rocket reserves the right to adjust the range at hire or during the year due to market shifts.

In addition to base salary, Rocket offers a competitive total rewards package that may include:

• bonuses (short-term incentives)
• medical, dental, and vision insurance
• life insurance
• 401(k) with company match and generous vesting
• paid vacation and holidays
• global shutdown days between Christmas and New Year's
• a variety of wellness resources and employee support programs
• eligible for added forms of compensation, such equity awards (long-term incentives)

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.