Head of MRT Clinical & Regulatory Ops



August 1, 2014

The Head of MRT Clinical and Regulatory Operations will be responsible for clinical and regulatory leadership for MRT Programs. The Head of MRT Clinical and Regulatory will interface with Shire R&D Leadership and will execute programs primarily through the use of external partnerships, consultants and vendors. The scope of this position includes:
* Design, implementation and monitoring of clinical studies of mRNA-based therapeutics designated for clinical development.
* Development of protocols and case report forms, which will provide adequate efficacy and safety information particularly focused on Phase 1 and 2 clinical trials.
* Interaction with data management personnel to plan data entry and analysis; recruitment/screening/selection of competent investigators; organization of investigators' meetings; assurance that Good Clinical Practices (GCPs) are followed; assurance of timely completion of studies; monitoring data for safety and efficacy trends by
reviewing clinical data; and the writing of clinical reports upon completion or termination of studies (in cooperation with statistical staff).
* The review of requests for results of Investigational New Drugs (IND) studies, and provision of input for pharmacokinetics and pre-clinical studies.
* Preparation of INDs, including protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios.
* The planning of clinical programs and development of a timetable, budget and resource analysis for clinical programs and personnel administration.
* Establishment and maintenance of relationships with alliance partners, external companies, investigators and opinion leaders to optimize performance on clinical trial activities.
* Preparation of manuscripts for technical journals and presentations at scientific meetings.

* 30%: Develop a clinical trial strategy and oversee all clinical trial activities
* 15%:Lead all interactions with regulatory authorities
* 15%:Build and maintain key opinion leader relationships
* 15%:Serve as the clinical lead for advisory meetings
* 25%:Liaise with multiple contractors and internal stakeholders, including manufacturing operations, CROs and business development

Education and Experience Requirements:

A MD or MD/PhD in a relevant scientific discipline and a minimum of 15-20 years of experience in clinical research. Experience in the Biotechnology or Pharmaceutical industry.

Key Skills, Abilities, and Competencies:
* Extensive experience in clinical development required with particular emphasis on phase I/II clinical trials
* Demonstrated leadership centered on the ability to develop an overall clinical-regulatory development strategy
* Comprehensive understanding of clinical regulatory requirements, and knowledge of all relevant guidelines
* Ability to work in a small startup environment, interact across multiple disciplines, and manage outside consultants
* Experience in managing alliance partnerships
* An understanding of regulatory requirements necessary for the various phases of drug development and experience interacting with regulators
* A work history which demonstrates: ability to lead and build relationships to gain the respect and trust of others; Intellectual quickness, curiosity, discipline, resourcefulness and resilience; Ability to work with flexibility, efficiency, enthusiasm, and diplomacy both individually and as part of a team effort
* Demonstrated skills in building collaborations across organizations and guiding therapeutics from early development through clinical testing
* Effective skills in communication to diverse decision-making groups including external regulatory agencies; excellent ability to articulate strategic vision and scientific underpinnings of technologies
* Excellent problem solving and interpersonal communication skills

Other Job Requirements:

* Occasional domestic and international travel Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives

As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Please apply at: Application URL: http://www.aplitrak.com/?adid=YWxlYXRvbi42MDk0NC4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ

Apply Now

  • Company Shire
  • Contact Name Shire
  • Position Location Lexington, Massachusetts
  • Job Reference Code 8887BR
« Back to list


Fresenius Medical Care