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Head, Clinical Operations, Elpidera

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POST DATE 8/11/2016
END DATE 1/6/2017

Moderna Therapeutics Cambridge, MA

Cambridge, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)


Head, Clinical Operations, Elpidera


Moderna Therapeutics is seeking a Head, Clinical Operations for its Rare Disease initiatives. This position will initiate and lead clinical operations initiatives across projects as well as external contractors and CROs. This role will report internally to executive leadership and will participate in development of the strategy and implementation of clinical development programs at Elpidera.


* Leadership of first-in-human clinical trials with adherence to GCP and FDA Regulatory compliance

* Managing internal staff, cross functional leadership and CRO/vendor management related to clinical trial operations aspects

* Lead in the selection and oversight of CROs and other vendors

* Develop and lead the review of clinical outsourcing strategies and plans

* Manage assigned clinical trial budgets and resource assignment

* Responsible for representing Clinical Operations on cross-functional project teams and Vendor/CRO operational meetings and ensuring compliance with global operational standards and procedures

* Initiate and lead monitoring oversight activities are conducted in accordance to Moderna and ICH/GCP standards

* Represent the Company externally to Investigators and trial site administrators

* Oversee activities leading to internal GCP audits and regulatory inspections related to clinical trial conduct

* Maintain oversight and participate in the review of departmental SOPs to ensure compliance

* Develop and maintain strong, collaborative relationships with key stakeholders in Clinical Development and the broader Moderna organization


* At least 8-10 years of clinical trial management, biopharma industry experience in rare disease

* Multi-dimensional Clinical operations background with capability of devising plans for operational challenges such as site activation, patient enrollment, monitoring oversight, protocol deviation management, data cleaning, etc

* Cross Collaboration proficiency with other functions such as R&D, Finance and production

* Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world

* Experience in regulatory GCP inspections/audits

* Outstanding verbal and written communication skills, in addition to excellent organizational skills

* Ability to work in agile, small team environment with fast pace and diverse programs

* Proven track record as a leader in clinical trials in the biotech or pharmaceutical industry; Creative, capable problem-solver


* 10+ years of management experience in a clinical research environment preferably with Rare disease and pediatric studies

* Demonstrated excellence in First in Human clinical operations activity; managing multiple global Clinical Research projects in different phases (I IV) and in different therapeutic areas, ability to travel and manage selection and oversight of multiple Clinical Research organizations and individual vendors


* Personal Leadership Skills balanced with Team Orientation

* Outstanding Communication Skills (oral & written)

* Goal Orientated

* Collaborative and respectful

* Common Sense

* Curious

* Bold and relentless