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Biogen

Clinical Country Site Lead (Southwest)

RemoteUnited States only· Prefers United States
Published
Role
Operations
Experience
Lead
Company size
Mid-size
$134k–$179k/yr
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Open to US only · Prefers United States. Set where you work from to check your eligibility.

The listing prefers candidates in United States.

No BS summary

Clinical research leader with 8+ years managing clinical trial activities, especially sponsor oversight with CROs/vendors. Must be US-based, strong in ICH/GCP, local clinical operations, project management, English communication, and willing to travel 50–75%.

Required languages

English Proficiency in non-English speaking countries; strong communication skills including English proficiency in role description.

What you'll do

  • Support and manage the internalized flexible model, including effective collaboration and potential management with Clinical Monitoring Leads (CMLs), CRAs, and communication with FSP partners.
  • Support and collaborate with partners working under the FSO model.
  • Maintain up-to-date local knowledge of therapeutic areas researched by Biogen and clinical trial requirements.
  • Engage in operational and scientific discussions to provide country-level information on studies and programs.
  • Drive global operational strategy by delivering study information.
  • Manage investigator and site relationships to foster collaboration and satisfaction.
  • Lead local activities for country and site selection to incorporate feedback from local stakeholders.
  • Serve as the primary contact for strategic development and execution of sponsor oversight of CRO activities.
  • Oversee Sponsor Oversight Visits, audits, and inspections to ensure compliance with regulations.
  • Monitor trial progress, address local challenges, and align with global teams effectively.
  • Act as Lead CCSL for study or program leadership, including training and coordination of site selection activities.
  • Build relationships across the organization while operating remotely.

What they require

  • Bachelors Degree with a science background and experience required; advanced/graduate degree preferred.
  • 8+ years of clinical research experience including experience managing clinical trial activities, especially sponsor oversight with CROs/vendors.
  • Understanding of cross-functional drug development processes and scientific/clinical knowledge across key therapeutic areas.
  • Familiarity with ICH/GCP and country regulations.
  • Strong organizational and project management skills.
  • Proficiency in relevant IT tools for virtual teamwork.
  • Excellent knowledge of clinical operational activities in local geography.
  • Strong communication skills, including English proficiency in non-English speaking countries.
  • Willingness to travel 50-75% (2-3x/month).
  • Preferred: Leadership skills and interpersonal skills.
  • Preferred: Collaborative decision-making approach.
  • Preferred: High emotional intelligence and cultural awareness.
  • Preferred: Preferred locations: Colorado, Texas, Arizona, Midwest region.
  • You thrive in an external-facing role, leveraging deep clinical research experience and scientific knowledge to drive strategic decisions.
  • Your organizational skills and project management abilities allow you to set clear goals and manage multiple tasks efficiently.
  • You are customer-focused, culturally aware, and possess high emotional intelligence.
  • Your strong communication skills, including proficiency in English, enable you to assimilate new knowledge rapidly and convey complex information with clarity.

Benefits

  • Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities.
  • Medical, Dental, Vision, & Life insurances.
  • Fitness & Wellness programs including a fitness reimbursement.
  • Short- and Long-Term Disability insurance.
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31).
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance.
  • 80 hours of sick time per calendar year.
  • Paid Maternity and Parental Leave benefit.
  • 401(k) program participation with company matched contributions.
  • Employee stock purchase plan.
  • Tuition reimbursement of up to $10,000 per calendar year.
  • Employee Resource Groups participation.
  • Stability and resources of a well-established business.
  • Environment where individual contributions make a significant impact.
  • Opportunities for learning, growth, and expanding skills.

American multinational biotechnology company

BiotechMid-sizebiogen.com/
$134k–$179k/yr