Director, Strategic Development - Rare, Orphan & Paediatric Diseases

United States
11 Jun 2021
11 Jul 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Director, Strategic Development - Rare, Orphan & Pediatric Diseases

Remote, Anywhere in the US

Who We Are

Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Position Overview

As the Director of Strategic Development for Rare, Orphan & Pediatric Diseases, you will be responsible for contributing to business development activities, providing operational and strategic leadership as well as executive oversight, ensuring client delivery.

Specific tasks include:

  • Therapeutic Strategy:
    • Review and provide strategic input for client proposals and budgets
    • Provide strategic input for and participate in bid defense meetings
    • Identify appropriate internal and/or external advisors in specific therapeutic areas/indications, including KOLs and patient advocacy groups, and integrate their considerations in the development of a customized project strategy
    • Provide internal training of proposals, BD, and operational staff on study strategy
  • Business Development:
    • Work with the business development team to expand the pipeline of business through new and existing client relationships
    • Attend client meetings to conduct capabilities presentations and assess client objectives
    • Maintain scientific, competitive, and strategic intelligence.
  • Operations:
    • Drive program strategy to meet client and operational objectives by leveraging past experiences and knowledge of the therapeutic area and providing training and guidance to the operational team
    • Attend business development, outsourcing, and operational and meetings
    • Provide executive oversight by interacting with the client and the delivery teams to ensure project deliverables and client satisfaction; may include formal project team governance role and/or relationship governance with select clients
    • Liaise with PM leadership and the project managers to understand project risks and mitigation plans, set KPI's, and provide on-going project reviews to assess project performance over the life of the project
    • Perform project profitability analysis in conjunction with the finance organization


  • Life science degree, preferably with a post-graduate qualification in sciences or business management
  • Minimum of 10 years' project management and operational experience, preferably in a CRO environment
  • 4+ years of effectively contributing to business development at both tactical and strategic levels
  • CRO Experience required
  • Strong understanding of the clinical trial process (Phases I - IV)
  • Understanding of financial processes and profit/loss statements
  • Understanding of GCPs, ICH guidelines, FDA and other applicable country regulations
  • Proficiency in Microsoft Word, Excel, and PowerPoint, Outlook
  • Strong verbal and writing skills; English + local language, if relevant
  • This position requires the ability to travel 25%

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.

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