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Clinical Scientist

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

United Kingdom

Offer summary

Qualifications:

Minimum 3-5 years of drug development experience, Master's degree required, advanced degree preferred, Knowledge of clinical research and GCP, Strong verbal and written communication skills.

Key responsabilities:

Support regulatory filings and correspondence
Prepare reports for product maintenance

LanceSoft, Inc. XLarge https://www.lancesoft.com/

1001 - 5000 Employees

See more LanceSoft, Inc. offers

Job description

Objectives/Purpose:
The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases.
The PDT BU R&D group is seeking to hire a Senior Clinical Scientist contractor to support the maintenance of marketed products. Responsibilities will include but not be limited to support of regulatory filings, regulatory correspondence, and preparation of reports.
A minimum of 3-5 years of drug development experience is required. Experience with developing products for bleeding disorders is desired.
The incumbent’s will contribute to guiding a multi-disciplinary, multi-regional, matrix team through highly complex decisions.
This individual has responsibility for integrating the input from various disciplines to create, maintain, and execute a global plans for product maintenance and geographic expansion.
Dimensions and Aspects:
Leadership:
• Global perspective with a demonstrated ability to work across functions, regions, and cultures
• Ability to identify potential challenges and opportunities and make recommendations
• Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company
• Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization
• Invests in helping others learn and succeed
Decision-Making and Autonomy:
• Accountable for acting decisively and exercise sound judgment in making decisions with limited information
• Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence
• Ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities
• Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution
• Develops executable plans and meets budget and deadlines

Interaction:
• Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU
• Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions
• Strong communicator, able to persuasively convey ideas verbally and in writing
• Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders
Complexity:
• Delivers solutions to abstract problems across functional areas of the business.
• Identifies and solves fundamental issues for major functional areas through assessment of intangible variables.
• Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through exceptional influencing skills.
• Creates clarity of accountabilities in a global and highly matrixed organization, with a high degree of complexity
Requirements:
• Minimum of 3-5 years experience with clinical research drug development in a pharmaceutical, or biotech industry.
• Master’s degree required, advanced university degree preferred.
• Knowledge of clinical research discipline and GCP.
• Excellent verbal and written communication skills.
• Presentation, organizational and interpersonal skills are a requirement.
• Confident decision-making, and ability to work affectively as a team leader, team member or individually.
• Interest in application of clinical/medical knowledge in drug development