Regional Lead CRA | Exciting Ground-Floor Opportunity | Well Funded NJ Biotech: RETAINED SEARCH
Summary: Cornerstone Search Group has been retained by an exciting pre-IPO biotech company whose lead clinical candidate is a first-in-class, treatment that will revolutionize epileptic treatment. In this newly-created role, you will report into the VP Clinical Operations and work right alongside the founder/CEO and Chief Medical Officer. Given the smaller biotech environment, our client is seeking an experienced clinical site monitoring operations professional who is hands-on, flexible, forward-thinking, and can positively collaborate cross-functionally across all levels within the organization. This company has been attracting experienced and talented industry professionals and offers the “best of both worlds,” (i.e. small team comradery and a nimble, entrepreneurial environment where smart decisions are made quickly minus the red tape/bureaucracy, while also having the financial backing of some top-tier healthcare investors. As opposed to being a small fish in a big pond at a large organization, you will be a visible part of this company’s strategy, direction, and success.
Company: This pre-IPO biotech has a well-proven leadership team with proven success leading pre-IPO companies and prior success in this therapeutic area.
Location: This is a remote-based position (w/occasional team meetings in Summit, NJ).
Attractive Features about this Position and Company:
- Visible and Impactful New Position: This is a very important and impactful newly-created role where you will utilize your monitoring/site management experience. This is a position where you will have the ability to truly impact the organization (unlike in Big Pharma).
- Exciting Company: Work for a unique biotechnology company which is focusing on innovative therapies.
- Great Time to Join: This is a perfect time to join this company while they are at the ground-floor and an exciting inflection point as they are advancing further into development.
- CEO’s Track Record of Success: The CEO (who we know personally) has extensive leadership experience in the biotech industry and he is very personable and genuine.
- Manage site selection, initiation, monitoring and close-out visits of investigational sites for the Company’s clinical trials.
- 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.
- Oversee and conduct monitoring activities, develop collaborative relationships with investigative sites and personnel.
- Lead/manage assigned sites through regular contact to ensure site compliance, adequate enrollment, and understanding of study requirements.
- Assures that clinical sites are being managed properly and ensures action plans are put in place as needed to ensure compliance.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Accountable for the implementation and management of overall project and quality systems required for GCP and GMP compliance during clinical product development.
- Ensures regulatory inspection readiness at clinical sites.
Desired Background & Experience:
- A bachelor’s degree in life sciences or related field.
- 5+ years of relevant and progressive experience in on-site monitoring of clinical trials working at a pharmaceutical and/or biotech company, or a CRO.
- Experience with quality procedures and vendor audits preferred.
- Proven ability to work effectively in a fast-paced entrepreneurial environment, to be self-motivated, and to communicate effectively with senior management.
- Willingness and flexibility to travel up to 70% (Investigator meetings, site visits, etc.).
Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted/shared with us as confidential information. Any information provided/shared with us will not be shared with any parties outside of Cornerstone Search Group without your prior permission.
Brian Skurka | Partner
firstname.lastname@example.org – P 973-656-0220 x738
CORNERSTONE SEARCH GROUP - Life Sciences Executive Search
6 Campus Drive | Parsippany, NJ 07054 USA
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