Project Manager – Clinical Research Pathology Services
Deciphex
Google Cloud Platform
Lead Clinical Scientist, Transplant
Biogen
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $180,000 - $248,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Help lead the design, execution, and analysis of late-stage organ transplantation clinical studies, ensuring alignment with program strategy while adhering to GCP and regulatory requirements
- Develop and refine clinical development plans, study protocols, and other trial related documents.
- Provide medical and scientific oversight of clinical trials
- Implement study-specific medical monitoring plans and support medical monitoring activities across clinical trials including ongoing review of patient eligibility, safety data, and protocol adherence
- Monitor patient safety by reviewing adverse events, laboratory results, and emerging data.
- Provide real-time medical guidance to investigators during trial conduct, including assessment of complex or unexpected clinical scenarios
- Participate in and contribute to Data Monitoring Committees, adjudication committees, and safety review meetings as required
- Support case report form design and modification to ensure optimal data capture, scientific rigor, and operational feasibility
- Direct ongoing review of clinical trial data, including query resolution, to ensure completeness, accuracy, and consistency.
- Partner with Data Management and Biostatistics to develop high-quality data review plans.
- Ensure that study databases are clean, audit-ready, and meet standards for regulatory filings.
- Work with clinical operation and site investigators to proactively identify and address enrollment challenges, ensuring recruitment goals are met
- Develop, maintain and strengthen investigator and investigator site relationships at specific study sites.
- Implement strategies to support patient enrollment and retention, including improving site engagement, participant experience, and adherence to study procedures
- Provide leadership to cross-functional project teams, partnering with clinical operations, biometrics, regulatory affairs, biomarkers, clinical pharmacology, and medical writing to deliver on study objectives.
- Establish and maintain strong external collaborations with investigators, academic partners, CROs, and other clinical trial stakeholders to ensure successful study execution.
- Represent Biogen at global scientific conferences, investigator meetings, and advisory boards.
- Support preparation and presentation of clinical data to health authorities, including FDA and EMA.
- Anticipate scientific and operational challenges, proposing innovative solutions to advance program timelines and deliverables.
- Contribute to overall portfolio strategy by integrating emerging scientific insights and competitive intelligence.
Requirements
- Advanced scientific degree required (MD, PhD, PharmD, or equivalent)
- 6+ years of clinical development experience in the biotechnology or pharmaceutical industry or equivalent, preferably in organ transplantation
- Ability to survey and interpret scientific literature related to assigned projects
- Strong interpersonal skills and ability to collaborate across internal teams and with external clinical partners.
- Strong analytical skills coupled with excellent oral and written communication skills to present findings and relevant data with the ability to educate and influence senior stakeholders and external experts.
- Strong organizational skills and ability to thrive in a fast-paced environment while prioritizing and responding to changing business needs
- Willingness to travel domestically and internationally (approximately 30%)
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical developmentstudy protocolsmedical monitoringdata review plansadverse events reviewclinical trial data analysiscase report form designregulatory complianceGCPbiostatistics
Soft skills
interpersonal skillscollaborationanalytical skillsoral communicationwritten communicationorganizational skillsproblem-solvingleadershipadaptabilityinfluencing skills
Certifications
MDPhDPharmD
