Clinical Operations Leader:Innovative Biotech Co., New York City Job
Clinical Operations Leader:
Innovative Biotech Co., New York City
Summary: Our client is a highly attractive and innovative globally traded Biotech Company located in New York City. They are currently in the process of rapidly growing a Clinical Development and Operations group and are looking for a Clinical Operations Leader (Asst Director-level) to come in and lead/manage all aspects of Clinical Operations within particular Therapeutic Areas, including Cardiovascular and/or Metabolism. This ground-floor opportunity offers a best of both worlds environment including both an incredible amount of visibility/potential coupled with stability (publicly traded with a large amount of cash).
Position: Clinical Operations Leader
Location: New York City
Compensation: This company will make a fair and competitive offer depending the depth and quality of relevant work experience and accomplishments. This includes a double digit bonus and can include stock options.
Attractive features about this position and company:
- Stability Growth: Our client has a strong multi-therapeutic pipeline, is publicly traded, and has large amounts of cash on hand. You would be joining the group before they grow larger.
- Visibility: A challenging, highly-visible role where you will work alongside of the Medical Directors, CMO and EVP.
- Innovative Company: Work for a unique biotechnology company which is focusing on innovative therapies.
- Unique Culture: Work in a very collegial, fast-paced environment, which will not only gain you valuable experience, but also tremendous opportunity for internal growth/advancement.
- Reporting Structure: You will be working very closely with a personable and highly respected Medical Director.
Responsibilities:
- Provide overall leadership to one or more global clinical programs.
- Develop relationships with, and is the primary contact for, key stakeholders and co-development partners.
- Communicate regularly in regards to study status and escalates unresolved issues to upper-management.
- Develop plans that deliver studies on time, with the most efficient use of budget and resources, and risk and quality assessment.
- In accordance with the overall project plan, establish and maintain accurate study level plans in internal project management software.
- In collaboration with other functional groups, develop and oversee the implementation of the audit, quality, risk management and contingency plans.
- Lead the development of the protocol feasibility.
- Oversee the development and active management of the study patient recruitment strategies.
- Responsible for ensuring therapeutic area training.
- Finalize country selection for studies across project.
- Oversee the drug supply requirements and availability across studies.
- Chair core meetings, ensuring minute-taking is rotated and appropriate follow-up is taken on action points.
- Organize agenda and oversee the chairing of investigator meetings and CRO kick off meetings.
- Ensure that data is reviewed in accordance with Data Quality plans.
- Lead the identification and selection of CRO/CRO partners.
Requirements:
- Bachelor's degree in a scientific or life sciences area. Master’s degree (MS) is desirable.
- 3-7 years of relevant Clinical Trial Manager and Clinical Research work/therapeutic expertise with knowledge of clinical drug development process in biotechnology/pharmaceutical or CRO industry required.
- Cardiovascular and/or Metabolism/Diabetes experience is a plus, but not required.
- CRO/vendor management is a must.
- Ability to develop and manage clinical program budget.
- Multiple therapeutic areas acceptable.
- Broad knowledge and cross-functional understanding of clinical trial methodology.
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Contact
Thomas J. Fascia
Director, Pharmaceutical Recruiting Practice
CORNERSTONE SEARCH GROUP, LLC
Pharmaceutical Recruiting Specialists
6 Campus Dr. | Parsippany, NJ 07054
p 973.656.0220 x 717 | f 973.656.0228
tfascia@cornerstonesg.com | www.cornerstonesg.com
http://www.linkedin.com/in/tomfascia
About CORNERSTONE SEARCH GROUP
Cornerstone is a Pharmaceutical | Biotechnology Executive Search Recruitment firm located in the heart of New Jersey's Pharmaceutical Corridor.
Cornerstone partners with Pharmaceutical, Biotechnology, and Consumer Healthcare companies to identify, attract and hire accomplished professionals from the Senior Staff through Executive levels that are involved in the discovery, development, and commercialization of drugs and therapeutic treatments for the US and international markets.
Cornerstone offers a comprehensive range of talent acquisition services including: Retained Search, Performance-Based Retained Search, Contingent Search (for full-time and consulting positions), and Strategic Advisory Services (e.g. organizational structure development, recruitment strategies, and compensation/benefit guidance).
Cornerstone has a deep reservoir of industry knowledge and contacts due to our single industry focus, a highly experienced management team committed to professional client service, and we continuously invest in our people, processes, and technology.
Cornerstone strives every day to meet and exceed our mission statement: Building Better Companies, Building Better Careers ®
Other Opportunities
Cornerstone Search Group is currently working on Executive Search Recruitment assignments in several of the following business areas: Discovery, Clinical Research Development, Medical Affairs and Commercial/Marketing, and in several of the following functional areas: Biostatistics, Statistical Programming, Clinical Operations, Clinical Research, Data Management, Health Economics Outcomes Research, Market Research, Medical Affairs, Medical Directors, Clinical Scientists, Medical/Drug Information, Medical/Scientific Communications, Medical Writing, Pricing Reimbursement, Product/Brand Management, QA/QC, Pharmacovigilance Drug Safety, Regulatory Affairs, Scientists, Sourcing and Pathologist. Please visit our company’s web site for a comprehensive listing of available positions/opportunities at www.cornerstonesg.com.
Key words: Clinical Trial Manager, Clinical Study Manager, Clinical Research Manager, Clinical Project Manager