Associate Medical Director, Gene Therapy Clinical Development - Cardiology

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 Cardiologist for the position of Associate Medical Director, Clinical Development. 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 in Chief Medical Officer of the company

Responsibilities

• Performs medical monitoring on one or more clinical trials: Provides study-related medical information and assistance, e.g., on:
  • medical questions from investigators, site personnel and non-study health care providers
  • safety findings, medical issues, and oversight of potential adverse events.
  • audits or inspection medical responses
• Lead medical data review on clinical trials with other colleagues on an ongoing basis.
• Provides clinical/medical input to support development of the protocol. 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.
• Oversight, approval and updates to Informed Consent Forms including responses to external stakeholder questions.
• Provides clinical/medical input to development of the Integrated Quality Management Plan.
• Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees. Oversee related charter development, committee presentations and documentation of outcomes.
• Inputs to, reviews, and approves, Risk Management Plan and Safety Review Plan. Ensures activities are conducted consistently with the approved plan and partners with key stakeholders (clinical operations, safety risk lead, etc) to develop and implement any risk mitigations.
• Reviews and approves country selection, site selection criteria, and contributes to authoring of site training materials.
• Serves as the primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of protocol.
• Reviews, and manages protocol deviations.
• Oversight of trial master file (TMF) compliance for clinical documents for respective studies.
• Inputs and reviews the Clinical Study Report including the review of narratives. Responsible for supporting disclosure of safety and efficacy data and trial conclusions. Contributes to primary publication of clinical trial results.
• May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan (PIP), Investigator Brochure (IB), IND/NDA Annual Reports, and Development/ Periodic Safety Update Reports and Regulatory authority responses) if required.
• 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

The successful candidate must have the following qualifications:

• MD/ DO or equivalent foreign medical degree, from a recognized medical school/university. 3-5 years of relevant academic/industry experience are required
• Cardiology training.
• Deep understanding of the science and genetics, underlying cardiomyopathy and heart failure
• Familiarity with clinical research and innovative imaging technologies in cardiovascular disease research, including echocardiography, magnetic resonance imaging, positron em