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Principal Clinical Trial Lead

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Location
Billerica, MA
Job Type
Direct Hire
Date
May 10, 2017
Job ID
2404130

KEY ACCOUNTABILITIES

  • Implements, conducts or monitors on-site clinical trials.
  • Takes responsibility for on-site operations of clinical trials, including documentation strategies, implementation of clinical trials protocols, standard operating procedures (SOPs) and case report forms (CRFs). May also help define or improve these but main emphasis will be on implementation. Conduct and be reponsible for clinical studies in one or more therapeutic areas.
  • Leads own team of professional staff to identify and resolve technical, operational and organizational problems of medium complexity.
  • Filters, prioritizes, analyzes and validates dynamic material from a diverse range of external and internal sources to respond to operational challenges.
  • Applies understanding of how different areas jointly contribute to achieving objectives within the sub-function (i.e. a subset of a function, typically consisting of several areas with independent budgets) supported by good industry knowledge to achieve objectives.
  • Be responsible for planning, coordinating, preparing and conducting as well as for the budget of clinical studies within assigned therapeutic area(s).
  • Steer all activities of the study-team and the contributions of further internal and external units.
  • Acquire clinical/pre-clinical development strategies in the assigned therapeutic area in cooperation with the involved parties.
  • Accountable to drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations
  • As core member of the Clinical Operations Team and leader of the Clinical Trial Team, aligns clinical trial team with organizational goals and objectives of the Clinical Operations Team and/or Global Program Team
  • May in addition take leadership of the Clinical Operations Team
  • Drives protocol development process. Provides clinical, scientific and operational input into concept sheets and protocol (rational, objectives, design), Case Report Form, and other key protocol/program documents and activities
  • Leads multiple cross-functional trial teams through start-up activities including study/site budgets and contracts, global geographic deployment (country/site identification, feasibility, selection), and country/site protocol approvals (MOH, IRB/EC) to study conduct, analysis and reporting
  • Leads the execution of clinical phases of assigned global programs across all phases (Phase 1-4) including post-marketing commitments and Biosimilars
  • Acts as a central point of contact for communication between the team and the external partners, developing mitigation and resolution strategies, and promptly responding to action items
  • Develops and leads the presentation on trial status to ICSC and other relevant committees for deviations from budget and timelines as needed, highlighting issues and risks
  • Qualifies operational feasibility and establishes and analyzes protocol-level budget and grants throughout the life cycle of the trial
  • Applies clinical and scientific knowledge to prioritize the clinical data review and cleaning
  • Drives oversight of CROs and vendor management at trial level according to the applicable partnership model
  • Acts as functional lead for process improvement initiatives
  • Understanding of trial feasibility elements
  • Understanding of regulatory requirements across countries

 

 

 

 

FINANCIAL DIMENSION

  • Trial budget within a program – up to EUR 300 m

 

 

STRATEGIC IMPACT

  • Ensures trials for high priority programs (eNPV > EUR 800 m, expected peak year sales > EUR 500 m, yearly development costs ~ EUR 25-30 m) are running according to plan and expectations, ultimately impacting timely delivery of program
  • Impacts the level of service and multiple teams within an area to meet quality, volume and timeliness objectives which affects the performance of the entire area.
  • Has impact on implementation of policies and concepts based on strategy (functional/divisional programs)
  • Contributes value-added perspectives or advisory services that are important to decision
  • Leads execution of all operational trial activities across multiple trials, therapeutic areas, development phases and geographies
  • Supports and provides input into sourcing strategy and implementation of partnership model with CROs
  • Oversight of CROs at trial level ensuring high quality and timely delivery of portfolio
  • Provide input to the concept sheet creation ultimately influencing country selection, study conduct and timelines
  • Acts as functional lead for process improvement initiatives

 

SCOPE OF PEOPLE RESPONSIBILITY

Management of people

  • Manages a team that consists largely of professionals and is accountable for the performance and results of the team.
  • Contributes to the definition of roles and responsibilities.
  • Contributes to the business and financial planning process.
  • Matrix management of multiple cross-functional trial teams (each trial team working on a different protocol)
  • Coaching and mentoring of CTLs and CTCs (among others)

COOPERATION

Internally

  • Guides, influences and convinces others, in particular colleagues in other areas as well as external customers or agencies.
  • Usually global, outside of the company, within/beyond own discipline.
  • Management of several local/regional projects
  • Other GCO functions – alignment with COT members on trial design
  • Early Stage Clinical Operations
  • Biosimilars Unit
  • GRED and GDM clinicians – development of protocol for the trial
  • Global Biostatistics – alignment on trial protocol
  • R&D Quality assurance
  • Other GRED and GDM functions as appropriate

Externally

  • Medical experts/key opinion leaders
  • CRO and other service provider/vendor personnel
  • Investigators & clinical trial site personnel
  • Representatives of institutions/hospitals
  • Representatives of Ethics Committees/Institutional Review Boards & Health Authorities

 

 

 

CANDIDATE’S PROFILE

 

EDUCATION

  • Advanced degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals) preferred or equivalent that provides knowledge of theories, principles and concepts within the relevant discipline.

WORK EXPERIENCE

Necessary professional experience

  • Requires substantial professional experience (approximately 8-10 years)  in clinical research in CRO or a Pharmaceutical or Biotechnology Industry environment with at least five (5) years of them depth and/ or breadth of expertise in clinical trial management including managerial responsibility
  • Proven experience in all aspects of clinical trial planning and start up (including budget and resource planning), and in executing the complete range of clinical trial activities, from start up through final trial report
  • Proven track record of having successfully led one or more multinational trials

JOB-SPECIFIC COMPETENCIES & SKILLS          

Specifies personal skills and competencies required

  • Solid leadership skills and influencing skills
  • Solid problem solving skills
  • Fluency in English (oral and written)
  • Position requires both domestic and international travel up to 30% of time