Manager, Global Clinical Operations – Immuno-oncology
Innovative & Rapidly Growing Global Biotech/Pharma – NJ
Summary: Our client is a reputable global biotech/pharmaceutical company with a proven track record of success which has experienced tremendous growth over the past few years. This company has an exciting oncology/immuno-therapy drug pipeline in early-late stage development. This is a great career opportunity where you will be able to utilize your clinical operations experience in managing operational oversight and cross-functional teams/relationships and gain valuable experience working on a variety of innovative/promising biologic compounds across multiple cancer indications. The right person for this company is someone who will bring fresh new ideas to the team, a big picture thinker, and will be able to hit the ground running.
Attractive Features about this Company and Position:
- World Class R&D Organization: Gain valuable experience working for a world-class Global company whose R&D organization is considered among the most productive and innovative in the industry.
- Culture & Environment: Not only will you gain valuable experience working on high profile global oncology trials, there is very real opportunity for internal growth/advancement.
- Cutting Edge Pipeline: Our client has a deep and diverse pipeline and portfolio of oncology biologic assets.
- Flexibility: Work for a company that is known for treating its employees well and providing a flexible work environment.
- Innovation-focused Company: You will be part of an organization that is focused on continuous innovation and creativity.
- Competitive Compensation Package: In addition to a base salary, this will include annual double-digit bonus, stock incentives, 401k automatic company contribution & matching, great benefits, flex time, etc.
Location: NJ metro area
- You will be an integral member in driving the planning and execution of global oncology clinical trials; manage the operational responsibilities of daily trial activities for oncology studies. This can include a range of cancer indications.
- Serve as project team leader accountable for the development and execution of these global trials with matrix management responsibility of the clinical trial team.
- Build relationships with internal and external partners (alliance partners, regulatory authorities, university/scientific associations).
- Clinical protocol development, protocol feasibility, forecasting and budget management, CRO/vendor selection and management.
- Develop relationships with key stakeholders and co-development partners.
- Preparation of clinical outsourcing specifications and in the follow-up with day to day operational activities with the CROs and vendors.
- Work on exciting new oncology products in development and support the life cycle management strategy for marketed products.
- Assist in program level activities (e.g., tracking of oncology clinical compound publications, development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, and responses to Health Authorities questions).
- Bachelors degree is required (preferably in life sciences area). Advanced degree is preferred.
- Relevant experience in Clinical Operations (CRO/vendor management, study management, budgets/timelines), Cross-Functional Management, Project Management, and Clinical Development working at a pharmaceutical and/or biotech company.
- A leadership presence as the primary operational contact for a global team of individuals assigned to the protocol.
- Experience managing cross-functional study management teams.
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Brian C. Skurka | Director
CORNERSTONE SEARCH GROUP, LLC – www.cornerstonesg.com
Life Sciences Executive Search
6 Campus Drive | Parsippany, NJ 07054