Director, Site Activation Therapeutic Lead

Location: United States

Notice

This position is no longer open.

Requisition Number: 2948

Position Title: Director, Site Activation and Regulatory Therapeutic Lead

External Description:

SUMMARY: The Director, Site Activation Therapeutic Lead (SATL) is responsible for the overall delivery, operational and financial performance of global Site Activation within a therapeutic area or customer. This is a leadership role reporting to the Senior Vice President from whom the job holder receives coaching and direction. The jobholder will have direct--and may have indirect--management responsibilities for the site activation performance of projects in a region or therapeutic area or significant customer portfolio.
 
Responsibilities and tasks may include but are not limited to:
 
Leadership and Operations

  • Provide strategic leadership, promote expected behaviors and establish a culture within assigned Site Activation Therapeutic Area that is aligned with Worldwide values and objectives.
  • Apply knowledge and experience with regulatory and legal requirements related to site activation activities; develop and approve processes in collaboration with other SATLs
  • Conduct Monthly Portfolio Review meetings within therapeutic area or customer portfolio that result in trending improvement of site activation delivery as measured by department and project performance indicators
  • Oversee the development, implementation and adherence to site activation project plans and performance indicators
  • Ensure consistency in operational and financial delivery within assigned therapeutic area
  • May contribute to the development and review of site activation-related SOPs and other Quality Management Documents

Business

  • 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
  • May provide operational leadership to bid defense meetings and may attend bid presentations for key accounts
  • Establish discipline and consistency within assigned Site Activation Therapeutic Area in the management of scope (change order) and risk throughout project delivery
  • Poactively 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

  • Develop and maintain connections and productive working relationships with customers
  • Manage and prevent internal and external site activation escalations within assigned therapeutic area of customer; facilitate resolution of issues arising within the customer relationships
  • Advises 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
  • Partners with Worldwide Business Development to gain repeat business with existing customers

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  

Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
 
OTHER SKILLS AND ABILITIES:

  • Demonstrated expertise in strategically leading customer focused multi-project/program teams resulting in positive customer relationships and repeat business
  • 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 ten (10) years of global clinical pharmaceutical industry experience including 5 years demonstrated skills and competency in management, including direct management of staff in a global environment
  • Demonstrated ability to inspire effective teamwork and motivate personnel within a matrix system
  • Experience in managing global development programs
  • 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 #LI-Remote

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Employment Type: Regular

Community / Marketing Title: Director, Site Activation Therapeutic 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.

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