We are developing innovative treatments using our gene editing platform to target solid tumors.
This is an exciting opportunity to become an employee of a high energy, start-up biotechnology organization that strives to discover, develop and commercialize novel first-in-class therapeutics. We are looking for an enthusiastic candidate who understands the innovative and entrepreneurial environment of a start-up biotechnology company and, who is willing to do what it takes to contribute to the success of the organization.
Position Summary:
This position is a strategic leadership role accountable for leading programs, including all operational activities and cross-functional trial activities, and managing study management staff across our portfolio. This role is responsible for strategic planning & oversight, delivery of all operational activities in accordance with the Clinical Development Plans (CDPs) and in accordance with GCP guidelines, line management including recruiting, building, and maintaining
a best-in-class Study Management organization.
Essential Functions / Responsibilities:
Manage all operational and strategic operational aspects of clinical development programs.
Provide oversight for clinical trial site management, assuring the timely and high-quality implementation of clinical studies, including site selection, clinical study agreement process, CRF design, study document preparation, study initiation, patient enrollment,
monitoring oversight, data collection, and report writing.
Contribute to clinical operations resource strategy including identifying and managing external resources such CROs, contractors, clinical operations consultants, and other external vendors across studies/programs.
Recruitment and oversight of Study Management staff across the portfolio.
Contribute to scenario plans, high-level forecasting of timelines, assessing global program-level feasibility, estimation and allocation of resources and budget, and development of high-level operational strategies.
- Develops and communicates budget, resource, risks and timelines to internal and externalstakeholders.
- Operate at strategic level including input into risk management plans, business valueassessment, long range planning and therapeutic area/indication expertise.
- Accountable for providing functional and program leadership with oversight, guidance,and expertise to all Clinical Operations staff assigned to the clinical program.
Required Education and Experience:
Bachelors (preferably in a Life Science or Business discipline) or equivalent.
Minimum10 years industry experience.
Minimum 4 years project and line management experience.
Experience in leading and managing global phase 1-4 clinical trials within designated
timelines, resources and budgets.
Extensive experience in selection of CROs/ vendors and management of external
resources.
Strong working knowledge and understanding of operational and regulatory requirements
for drug development and approval in multiple key regions (ie. US, EU, China and
Japan).
Strong working knowledge ICH Guidelines and GCPs governing the conduct of clinical
Proven track record showing excellent clinical project management skills including clinical
supply logistics and managing approved budgets.
Broad understanding of clinical operations in relation to clinical development functions
(e.g. CMC and drug supply).
Strong financial acumen with experience managing clinical program budgets.
Good working knowledge of data management, data review and analysis, and drug safety
and Pharmacovigilance.
Demonstrates excellent communication (written and verbal), presentation and
interpersonal skills.
Ability to travel as required.
Preferred Education and Experience:
• Experience of early clinical development, particularly with NASH, antiviral or anti
infectious, cancer or autoimmune compounds is preferred. • Experience in rare disease drug development is desirable.
qualified candidates should email resume and cover letter to jobs@tseworldwide.com