Site Activation & Regulatory Affairs Business Development Lead

Location: Morrisville, North Carolina, United States

Notice

This position is no longer open.

Requisition Number: 1584

Position Title: Site Activation and Regulatory Business Development Lead

External Description:

The Site Activation and Regulatory Business Development Lead (SAR-BD Lead) is responsible for developing Site Activation and Regulatory strategies and budgets into compelling and competitive proposal offerings leading to bid defense and award. The SAR-BD Lead serves as an expert resource, trainer and coach for other members of the SAR department to achieve new business objectives.
 
This is a leadership role reporting to the Senior Vice President, Site Activation and Regulatory. The jobholder may have management responsibilities for the site activation performance of projects in their assigned therapeutic area or customer portfolio.

 
RESPOSIBILITIES: 
Responsibilities and tasks may include but are not limited to:
 
Leadership and Operations:

  • Provide strategic business development leadership, promote expected behaviors and establish a culture in Site Activation and Regulatory that is aligned with Worldwide values and objectives
  • Train and coach Site Activation and Regulatory team members to learn about the proposal process and develop strategies and budgets into compelling and competitive business offerings
  • Have and apply knowledge and experience with global (country/local) regulatory and legal requirements related to site activation activities; develop and approve processes in collaboration with Site Activation Therapeutic Leads, Business Development, Project Management, Site Management and other functional areas
  • Achieve operational and financial performance targets through robust proposal budgets and strategies
  • May contribute to the development and review of site activation-related SOPs and other Quality Management Documents
     
    Business:
  • Provide operational leadership to bid defense meetings and may attend bid presentations for key accounts
  • May be assigned to lead or review and approve strategy, content and costing of proposals in collaboration with Business Development, Project Management, Site Management and other functional areas
  • Proactively interact cross-organizationally to develop and learn about emerging business, therapeutic, and operational strategies that improve service to our internal and external customers
  • May help develop and implement cross-functional initiatives for continuous process and quality improvements
     
    Customers:
  • Instill confidence from our customers during the proposal and bid process through knowledgeable and accurate communication of our startup strategy
  • During the bid process, advise customers on Site Activation issues, including regulatory requirements
  • May represent Site Activation at a customer Governance meeting within the assigned therapeutic area or customer portfolio
  • Partner with Worldwide Business Development to gain repeat business with existing customers
  • Provide input into patient facing materials and patient recruitment strategies from a regulatory perspective
     
    Site Activation Team Management and Resourcing:
  • Responsible for management of site activation resources in assigned therapeutic area in collaboration with Site Activation Global Performance Leads, HR and/or Finance
  • Oversight of regulatory compliance and requirements for Site Activation activities ensuring that these are managed effectively and appropriately reflected in the project plan
  • Coordinate with internal departments to ensure global staffing plans and forecasts are accurate, adequate and agreed by Worldwide functional groups and customers
  • In collaboration with HR People Partners, manage direct report appraisals, development, hiring and termination within assigned therapeutic area  
  • Occasionally perform site activation “hands on” functional tasks within assigned therapeutic area when successful delivery depends upon it 

OTHER SKILLS AND ABILITIES:

  • Demonstrated experience with effectively persuading internal and external customers and engaging in difficult conversations
  • Demonstrated ability to manage projects and people in ambiguous and time-sensitive situations, e.g., when desired non-critical information is not available before the decision is required
  • Experience with requirements and expectations of at least one cross-functional department such as Regulatory compliance, Feasibility, Site Management, Project Management, or Patient Recruitment is preferred
  • 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

 
REQUIREMENTS:

  • 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 demonstrated skills and competency in managing teams in a global environment
  • 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 drug development process and client needs 

#LI-HD1

City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Site Activation & Regulatory Affairs Business Development Lead

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Research Triangle Park, North Carolina US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

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