Clinical Trial Lead, Immunology and Neuroscience, Medical Evidence Generation

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The Clinical Trial Lead, I&N will be responsible for the day-to-day oversight of the MEG BoW which provides scientific expertise necessary to design and deliver Medical Affairs Sponsored Trials, execute on the ISR book of work, and co-develop Integrated Evidence Plan

The Clinical Trial Lead for assigned asset is responsible for driving the development, tracking, and maintenance of the Integrated Evidence Plan, provide oversight of Investigator Sponsored Research (ISR) Book of Work 
 

Key Responsibilities

• Clinical Scientist on assigned MASTs, ensuring quality execution of deliverables for all phases of assigned MASTs (start-up/conduct/closure), through activities such as:

  • Protocol design concept sheet, Protocol and ICF development

  • Site-facing activities

  • CRA training materials

  • Data quality activities; ensure consistent, quality data review across trial teams

  • Investigator Meetings, SIVs, Advisory Board, and Study committee (e.g., DMC) activities

  • Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, regulatory responses)

• Develop IEP that reflects asset strategy, market priorities, and medical data generation support in partnership with cross functional teams including (but not limited to) GDD, Translational Development, & HEOR

• Develop Areas of Interest based on key open data questions identified in the IEP with market input in collaboration with WWM

• Identify ISR studies at risk for failing to meet timelines and negotiate mitigation plans with key internal stakeholders and investigators

• Assist in reviews of concepts through RFP process, including providing context for ongoing book of work, area of interest development, and upcoming data read outs

• MEG representative at AIMs for assigned asset and AIMs working team lead

Qualifications & Experience

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN, or other scientific field preferred) with at least 2 years’ experience with clinical trial oversight

• Demonstrated proficiency in driving and managing company-sponsored clinical trials and leading teams (e.g., Clinical Scientist team lead)

• Demonstrated track record of leadership in a complex, matrix environment.  Experience delivering successful results in a variety of business situations.

• Excellent communication skills and experience with difficult discussions.

• Successful track record of leading through influence and working across complex, global organizational matrices

• Able to analyze, interpret, and present data

• Ability to self-supervise, and act independently to identify/resolve program level issues

• Proficient critical thinking, problem-solving, decision-making skills, oral and written communication skills

• Strong leadership presence

• Commitment to Quality

• Adaptable / Flexible

• Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally

• Promotes a culture of scientific excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality, and effective communication

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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