Associate Director, Feasibility Lead

DirectorDirectorFull TimeRemoteTeam 1,001-5,000Since 1999H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

68 days ago

Salary

$146.8K - $220.2K / year

Bachelor Degree5 yrs expEnglish

Job Description

• Accountable for leading and conducting the end-to-end data-driven feasibility process. • Proactively seeks input from customers, which may include patients, sites and other Genmab functions both in and outside of DevOps. • Responsible for the creation and maintenance of study-level patient enrolment forecast based on final operational plan approval and final feasibility. • Point of contact for assigned program and study-level feasibilities, leading cross functional teams to develop, validate and refine allocation strategy, inclusive of timelines, scenarios, and risk mitigation plans. • Identify and resolve events in the indication landscape (e.g. competitive landscape) that represent operational risks for the execution of clinical trials within the given indication/program. • Key contributor to the study’s operational plan. • Actively engages in continual process improvement; gathers cross-functional feedback and depending on business needs, this position may take leadership and/or will participate in initiatives that are at the intersection of technology, process and development experience.

Job Requirements

  • Minimum 5 years of direct feasibility experience in the pharmaceutical/CRO/biotech industry as a feasibility lead or equivalent.
  • Proven experience in data analysis and interpretation to inform strategic decision making, project management, developing study delivery strategies and tactical operational plans aligned to the commercial and regulatory objectives.
  • Excellent stakeholder management, concise written communication, ability to influence, clearly communicate and collaborate across an increasingly complex matrix environment.
  • Strong understanding of all aspects of clinical drug development, with particular emphasis on clinical trial design, trial execution, and strong knowledge about the feasibility and country/site allocation process of a program and/or study.
  • Must understand the Clinical Trial matrixed process from research through post-marketing Phase IV, including health authority guidelines.
  • Experience with MS Office and other (relevant) systems/tools.
  • Excellent communication skills in English, both verbal and written.
  • Approximately 5% business travel (overnight) required for internal meetings and congresses.

Benefits

  • 401(k) Plan: 100% match on the first 6% of contributions
  • Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
  • Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
  • Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
  • Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
  • Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses

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