Clinical Trial Manager | First-in-Class Cell Therapies | Unique Ground-Floor Opportunity | Quickly Growing Biotech | NJ/NYC
This is a newly created position for an experienced clinical trial/operations professional to join an exciting, innovative, and rapidly growing biotech company that focuses on developing novel first-in-class gene therapy treatments for rare diseases. You will report into a highly-regarded Head of Clinical Operations (whom we have a long-term relationship with) and will handle responsibilities across clinical operations both in-house and at clinical sites as needed. Given the smaller biotech environment, our client is seeking a candidate who is comfortable working in a hands-on, highly-visible and autonomous type of role, and who is flexible and truly wants to be a part of something special and unique.
This is a very exciting time within the organization as they are growing across a number of departments, and this is a great opportunity to join this company at the early stages in its growth and have the autonomy to truly impact the organization. This company has been attracting experienced and talented industry professionals and offers a small team camaraderie and fast-paced/collaborative environment, while also having a diverse development pipeline and impressive leadership team.
Attractive Features about this Company & Opportunity:
- New “Ground Floor” Opportunity: This is a perfect time to join this exciting high-growth biotech company, as they are still small and nimble and starting to build/grow their Clinical Operations team. You will have much more opportunity to grow and diversify your experience than at a larger, more compartmentalized company.
- Cutting-Edge Science & Gene Therapies: Leveraged by its unique technology/approach, cutting-edge science, and robust pipeline (which includes multiple compounds with “Fast Track” designation), this company is primed to make a splash in the cell therapy space.
- Impact & Exposure: You will report into an excellent Head of Clinical Operations and work alongside other Executive Leadership team members. So you will gain tremendous exposure at all levels and have the opportunity to make a visible/significant impact right away.
- Exciting Biotech Culture: The company offers all the attractive features sought with an entrepreneurial development/clinical-stage Biotech (small team camaraderie, impact, nimble, quick decision-making, autonomy, minimal layers/bureaucracy) which fosters more collaboration, communication and swifter decision making (i.e. emphasis on progress and moving things forward).
- Ability to Make a Real Difference: As opposed to being a small fish in a big pond in Big Pharma, you will work in a lean, entrepreneurial and collaborative environment where you will have the autonomy and visibility to make a significant impact on the company’s success, as well as in the lives of patients suffering from devastating diseases.
- This person will be responsible for managing the Company’s clinical trials, and will be a key interface with the CROs and other vendors in support of the Company’s clinical trials, and clinical sites.
- Perform site selection, study start-up, initiation, monitoring and close-out visits of investigational sites for the Company’s clinical trials.
- Development and active management of the study patient recruitment strategies.
- Lead/manage assigned sites through regular contact to ensure site compliance, adequate enrollment, and understanding of study requirements.
- Identify enrollment issues and help find solutions; travel when needed to meet with investigative sites and represent the company.
- Manage the progress of assigned studies by tracking patient recruitment and enrollment, CRF completion and submission, source data verification, drug accountability, data collection, and data query generation and resolution.
- Develop collaborative relationships with investigative sites and personnel.
- Assist in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports for regulatory filings.
- Prepare regulatory submissions, monitor patient safety and address protocol deviation, data quality issues, drug accountability and identify process improvements for assigned sites.
Education & Desired Experience:
- Bachelor’s degree in a nursing, scientific or life sciences discipline.
- 5+ years of relevant clinical operations experience (i.e. clinical trial management, site management, monitoring clinical trials, etc) at a pharmaceutical/biotech company or CRO.
- Clinical experience with rare/orphan disease products and/or gene therapy clinical trials, or a relevant complex therapeutic area is ideal.
Brian Skurka, Partner
firstname.lastname@example.org - P 973-656-0220 x738
Cornerstone Search Group, LLC
6 Campus Drive
Parsippany, NJ 07054
Keywords: Clinical Trial Manager, Clinical Study Manager, Clinical Operations Manager, Clinical Research Associate, Clinical Monitor, CRA, Clinical Site Manager, Clinical Site Management, Clinical Operations, Trial Management, rare diseases, gene therapy, cell therapy, orphan drugs