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Worldwide Clinical Trials · 2 hours ago

Senior/Director, Regulatory Pre-award Strategy - US/Europe - Remote

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

12+ years exp

Worldwide Clinical Trials is a global, midsize CRO dedicated to innovating and improving lives through clinical research. The Regulatory Pre-award Strategy Director will lead business development and pre-award activities, ensuring the development of competitive proposals and effective regulatory strategies.

Health CarePharmaceutical

Responsibilities

Have and apply knowledge of global start-up and regulatory activities to pre-award customer deliverables, resulting in a differentiated advantage for bid defense and award

Attend and provide leadership in bid defense meetings and presentations

Collaborate with Regulatory team leadership, Therapeutic Area leadership, Business Development, Project Management, Site Management and other functions to develop comprehensive pre-award site activation strategies

Develop and implement a comprehensive department-wide training and coaching program in collaboration with internal stakeholders

Train and coach department team members on pre-award activities to expand pre-award skills and increase flexibility when assigning qualified resources to pre-award work

Achieve operational and financial performance targets related to proposal budgets and strategies

Provide department resource projections and coordinate with the resourcing team to ensure pre-award staffing plans and forecasts are accurate and adequate

Proactively interact cross-organizationally to develop and learn about emerging business, regulatory, therapeutic, and operational strategies that improve service to our internal and external customers

Instill confidence in our customers during the proposal and bid process through knowledgeable and accurate communication of our startup strategy, including global / country regulatory requirements

May help develop and implement cross-functional initiatives for continuous process and quality improvements

May have line management responsibilities

Qualification

Regulatory AffairsGlobal clinical experienceSite activation strategiesDigitalSoftware systemsTeam managementClient needs understandingCollaborationPersuasionAdaptabilityCommunicationProblem-solvingTeamwork

Required

Demonstrated strong ability to define, organize, and develop complex site activation strategies into effective customer deliverables

Strong ability to collaborate effectively among multiple functions and personalities to achieve organizational goals

Demonstrated strong experience in effectively persuading internal and external customers and engaging in difficult conversations with desired results

Demonstrated ability to manage activities and people in ambiguous and time-sensitive situations

University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory, or laboratory technology) or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities

Minimum of twelve (12) years of global clinical pharmaceutical industry experience, including 3 years of demonstrated skills and competency in managing teams in a global environment

Experience in Regulatory Affairs in Pharma, CMC and/or Preclinical (Toxicology) knowledge

Experience in Scientific advisory support & briefing packages prep

Demonstrated ability to inspire effective teamwork and motivate personnel within a matrix system

Available for domestic and international travel, including overnight stays

Valid passport

Fluent in local office language and in English, both written and verbal

Broad knowledge of the drug development process and client needs

Preferred

Experience with requirements and expectations of at least one cross-functional department, such as Regulatory compliance, Feasibility, Site Management, Project Management, or Patient Recruitment

Interest and adaptability to drive innovative solutions for our customers, such as with decentralized clinical trials, remote and local home healthcare models, and direct-to-patient technologies

Aptitude or proficiency in using and learning digital and software systems

Deep knowledge of the US & Global regulatory landscape is a plus