Senior Vice President, Clinical Development

Company: Rocket Pharmaceuticals
Location: Cranbury
Posted on: August 6, 2022

Job Description:

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.Rocket is seeking an experienced Clinical Development professional for a leadership role to further our development efforts involving transformative cell- and gene-based therapies for rare and life-threatening hematopoietic and cardiovascular disorders. The candidate will have demonstrated expertise in leadership of multidisciplinary teams focused on clinical investigation of complex, severe disorders in a biotechnology or pharmaceutical setting.The position will report to the Chief Medical Officer and will involve intense collaboration within the organization and with external academic and industry partners to ensure optimal study conduct, reporting and adherence to GCP guidelines and other relevant health authority regulations.We are seeking a motivated, skilled, and operationally minded physician/executive to play a pivotal role in the ongoing development of several cell- and gene-therapy clinical programs as they approach registrational or health-authority submission stages, and to coordinate the growth and collaboration of multiple groups comprising the clinical development organization.It is anticipated that the position will involve extensive preparation of material supporting FDA & EMEA submissions, and oversight of clinical operations, data management, medical writing, and pharmacovigilance colleagues. Ongoing collaboration with statistical and regulatory colleagues, CMC, laboratory, and translational research scientists is essential. They will act as a mentor and provide strategic and technical oversight to their direct reports and, foster close cross-functional collaboration with Regulatory Affairs, Program Management, Quality Assurance, Translational Sciences, Business Development, CMC, and Commercial.Responsibilites:Partnership with global program leaders to ensure that the organization is equipped to achieve development goals and milestones and that team members are successfully pursuing and reaching key objectives.Operational oversight of multi-disciplinary and growing clinical organization, including oversight of clinical operations, data management, medical writing, and pharmacovigilance groups.Translation of complex scientific and therapeutic program goals into manageable workstreams for colleagues across multiple disciplines and levels.Participation in ongoing development of key strategic objectives for all programs and therapeutic areas.Communication of essential scientific, operational, and business objectives to internal and external stakeholders.Ensure that all studies and development plans, across the portfolio, are consistent with study aims and are designed to address the scientific and strategic needs of the company, with strong consideration for regulatory guidance, clinical practice, commercial landscape, and payor's needs.Ensure that all operational plans for trials are conducted within timeline, budget, and quality specifications.Lead the Phase 1-3 programs and develop the late-stage clinical development strategy.Provide and execute on strategic and organizational plan for building out the clinical department from first-in-human to pivotal studies, across multiple indications.Support clinical leads in the interpretation of data analyses of clinical trials, safety reviews, study readouts and topline results, authoring of clinical trial reports and scientific publications.Accountable for key clinical documents intended for regulatory submissions, including INDs, protocols and protocol amendments, investigator brochures, clinical study reports, briefing documents to support regulatory interactions, drug safety update reports, integrated efficacy and safety summaries for filings and benefit/risk ratios.Develop and maintain key opinion leader relationships and drive development-focused advisory board meeting processes.Establish and maintain relationships with alliance partners, internal/external stakeholders, investigators, and opinion leaders to optimize design and timely execution of clinical trials.Partner with patient advocacy stakeholders (both internal and external) to incorporate patient input into clinical protocols.As programs mature, partner with the Access and Reimbursement team on optimal health economic and outcomes research (HEOR) to secure conventional coverage and reimbursement.Act as key clinical stakeholder for business development & licensing activities and processesRequirements:PharmD or board-certified MD who has completed training in a complex specialty, ideally with experience in cell- and gene-therapy or other complex therapeutic area. Team leadership experience in biotech/pharma is essential, as is successful clinical development track record.Candidate must have demonstrated expertise in oversight of clinical studies evaluating advanced therapeutics in complex or life-threatening disorders. Must be able to function effectively as a leader of a multi-disciplinary teams. Excellent written and verbal communication skills, mentorship and problem-solving capabilities are essential. At least 15 years of relevant industry experience.Extensive Phase 1-4 clinical development experience in an industry setting, including first-in-human and pivotal studiesDirect experience with leading regulatory interactions in key regions (e.g., FDA, EMA), IND and other filings, scientific and clinical advisory boardsExtensive knowledge of clinical trial methodology, statistics, regulatory and compliance requirements governing clinical trials, including GCPHigh integrity and the ability to bring out the best in others, intellectually and interpersonallyPrevious experience in advanced therapeutic area product development, product registration, and launch and commercializationA 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.Full COVID-19 vaccination is required for employment at Rocket Pharmaceuticals.

Keywords: Rocket Pharmaceuticals, Trenton , Senior Vice President, Clinical Development, Healthcare , Cranbury, New Jersey