SCYNEXIS is pioneering a new class of antifungal medicines to help millions of patients worldwide in need of new options to overcome and prevent difficult-to-treat and drug resistant infections. Our lead candidate, ibrexafungerp, is a broad-spectrum, intravenous (IV)/oral agent in late-stage development for multiple indications, ranging from the treatment of vaginal yeast infections in the community setting to life-threatening invasive fungal infections in hospitalized patients. Our passion for the patient is the core foundation of our company and we use our resourceful mindset to drive our efficiency. The company is building its commercial organization and has initiated pre-launch activities for the upcoming launch of Ibrexafungerp in Vulvovaginal Candidiasis (VVC).
We are seeking a talented and highly motivated Associate Project Manager, R&D to be based in our Jersey City, NJ offices 2-3 days a week (flexible schedule for the ideal candidate). We are committed to positively impacting the lives of patients by developing innovative therapies, come join us and make a difference.
The Associate Project Manager, R&D supports the implementation of assigned clinical trials and general projects for the company. In addition, this role has hands-on responsibility and strategic oversight on the planning and execution of R&D related projects including, but not limited to clinical studies.
Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and other vendors. This position will report to the Senior Program Manager, Research & Development.
- Key contributor to the Clinical Operations team responsible for supporting the execution of assigned clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance, in line with corporate goals for approval of
- Participate in the selection of CROs and other vendors to support clinical study operations
- Manage consultants and collaborators under their responsibilities.
- Liaise with the clinical operations and development team to ensure proper planning and distribution of clinical trial supplies including forecasting of clinical supply needs and ensuring they are available in a timely manner.
- Support required country regulatory (e.g., FDA, MoH) and country/site IRB/IEC approvals/notifications.
- Support budgeting activities for clinical development activities and other departments as needed.
- Establish productive, interactive relationships with key internal departments, as well as the medical and scientific
- Assist with management and tracking of timelines for different departments, as needed.
- Create and implement cross-functional processes within the R&D department.
Requirements and Preferred Skills:
- Minimum Bachelor’s Degree in relevant field (Healthcare degree preferred).
- 2+ years of current pharma / biotech / CRO / Clinical Vendor experience, including Clinical Development and/or Clinical Operations with a minimum of 2 years of project management.
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory.
- Vendor oversight experience including oversight of CRO study.
- Experience working on Phase 2 and 3 trials; global clinical trial management a plus.
- Experience in designing clinical trial strategies to ensure successful clinical trial completion.
- Ability to apply clinical expertise to a clinical development program and evaluate clinical strategies.
- Application of Project Management tools, methodologies, practices, risk analysis, decision analysis and contingency.
- Ability to establish relationships with external individuals/organizations (e.g., investigators, KOLs/CROs).
- Strong project and vendor management, analytical and problem-solving.
- Effective verbal and written communication and interpersonal.
- Ability to quickly adapt to and manage an environment with rapidly changing organizational growth.
- Ability to manage multiple projects and responsibilities.
- Ability to travel domestically, occasional travel may be required to participate in investigator meetings or conferences.
For more information about SCYNEXIS, please visit, https://www.scynexis.com/about/careers.
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