Senior Clinical Scientist, Clinical Development

Key responsibilities

• Drive development of protocols/protocol amendments for clinical studies
• Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, Safety Management Plan, Medical Monitoring Plan, SRC Charter, IND, briefing books)
• Work closely with clinical team members within the assigned project to execute activities associated with the conduct of clinical trial
• Contribute to development of end-to-end clinical development strategy
• Prepare and/or provide input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
• Monitor, review and interpret safety and efficacy data of ongoing clinical trials
• Act as (clinical science expert) liaison to cross-functional project core team, clinical study teams, CRO’s, study sites and others
• Establish relationships with investigators, KOLs, partners and appropriate consultants
• Provide clinical scientific input to business development (e.g. due diligence) and marketing activities
• Perform literature research
• Develop and deliver presentations to internal and external stakeholders. Provide input in scientific communication plan and scientific publications

Your profile:

• Master’s in Life Sciences, Pharmacist or PhD in Life Sciences (preferred)
• At least 7-10 years of relevant experience in clinical development within the pharmaceutical industry, including development of CDPs and protocols
• Experience in conducting Clinical Studies in Oncology
• First experience in working on prostate cancer is a strong asset
• First experience working on studies in Anti-infectives in an asset
• Broad experience in the principles and techniques of data review, analysis, signal detection, interpretation and clinical relevance
• Well-versed in medical aspects of GCP, ICH, FDA, EMEA and other relevant guidelines and regulations
• Knowledge of the multidisciplinary functions involved in drug development process (e.g.: clinical operations, biostatistics, regulatory, business, etc.) and can proactively integrate multiple perspectives into the clinical development process for best end-results.
• Driven and proven abilities to perform responsibilities independently and with limited guidance
• Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget delivery. Focused on results, flexible and open-minded, able to adjust to changing circumstances.
• Strong interpersonal, verbal/written communication, negotiation and influencing skills in English
• Proven track record of effective decision-making
• Proven track record of working highly effectively, efficiently and collaboratively with multidisciplinary teams
• Demonstrates curiosity and challenges status-quo