Clinical Research Scientist

PRIMARY DUTIES:

- Integrates scientific knowledge and operational expertise to ensure excellence in development and translation of clinical research plans into efficiently delivered studies
- Responsible for supporting the development of methodologies to support proof of pharmacology, proof of mechanism and proof of concept studies under the remit of translational research
- Responsible for supporting individual clinical research studies (methodology studies, biomarker studies, proof of mechanism studies, proof of concept studies, medical device studies etc) including development of outline/core elements (in conjunction with the clinician), clinical review and oversight, and clinical representative on clinical study teams.
- Provides input to the operational strategy and feasibility of clinical research studies, in conjunction with development operations.
- Establishes relationships with key clinical experts/sites and uses this information to work jointly with CPM on site selection
- Be outward facing including learning/applying best practice from the external environment and being the key point of contact for clinical research
- Responds and contributes to novel study designs and ensures these novel designs are optimized for operational effectiveness to ensure timely and cost effective delivery
- Maintains a high degree of awareness of the external environment and ensures external innovations in scientific aspects and operational delivery are applied to the Research portfolio
- Tracks emerging study data to ensure appropriateness of the chosen subject population and proactively assesses the performance of techniques used for endpoint measures on an ongoing basis to ensure data quality
- Builds relationships with external investigators to promote scientific discussions, smooth operational delivery and avid interest in the company's success
- Understands and applies novel techniques and works with the platform lines to overcome potential barriers to ensure novel study data is captured and analyzed in a timely and effective manner
- Develops both scientific and operational expertise in novel techniques and trains others in their application.
- Tracks emerging safety profile of the drug, keeping clinician informed of changes in the safety profile as they occur in the assigned studies. Must be fully knowledgeable about the safety profile of allocated drugs on which studies are being conducted, or which are called for in the protocol.
- Ensures that serious adverse event monitoring is conducted according to SOPs and assists in timely reporting as required to regulatory authorities.
- Will need to be flexible in supporting a dynamic cross-therapeutic area research portfolio and may need to support multiple studies in parallel
- Contributes to the clinical development plan and biomarker strategy from PRISM through to POC
- Accountable to research clinician for ensuring that scientific aspects of study fit within the overall clinical strategy
- Partners with the clinical project manager (CPM) to ensure study delivery
- Partners with biologists and other relevant team members to ensure appropriate method development and sourcing of human tissues/biofluids

BEHAVIORAL COMPETENCIES:

- Acts Decisively - Makes timely and effective decisions by applying business and financial acumen. Makes decisions that translate into competitive advantage. Acts with urgency to deliver and removes barriers that hinder productivity
- Timely Decision Making - Makes effective decisions in a timely manner, often with incomplete information and under tight deadlines and pressure; able to evaluate risk and use this to inform decision making; does not prevaricate; actively seeks solutions to problems. Entrepreneurial and innovative; takes managed risks; thinks out of the box; challenges the status quo and dogma.
- Builds effective teams that can succeed in the adversity of drug discovery. Able to take teams through all stages of team development and willing to address matters that affect team performance. Blends people into teams when needed; creates strong morale and spirit in his/her team; shares wins and successes uses and builds on the expertise of others; fosters open dialogue; embraces diversity in the team; lets people finish and be responsible for their work; defines success in terms of whole team; maintains momentum through adversity.
- Accountability - For Self and Others - Takes personal accountability for outcomes. Sets the bar high for performance outcomes and holds others accountable for their commitments.
- Drives for results - Can be counted on to exceed goals; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self & others for results.
- Managingsets clear objectives and measures; monitors process, progress and results; designs feedback loops into work.
- Self Awareness - Recognizes own strengths and limitations and personal motivations. Actively seeks feedback and knows one's impact on others. Acts with authenticity and maturity.
- Self-knowledge - Knows personal strengths, weaknesses, opportunities and limits; seeks feedback; gains insight from mistakes; is open to criticism; isn't defensive; is receptive to talking about shortcomings; looks forward to balanced performance reviews and career discussions; manages own confidence.

SKILLS:

TRAINING & EDUCATION PREFERRED:

- Established scientific basis, as evidenced by science degree (BS/MS, PhD, or PharmD)
- Experience in managing complex projects

RELEVANT THERAPEUTIC AREA KNOWLEDGE AND EXPERIENCE:

- Comprehensive understanding of the drug development process with particular emphasis on Phase Ia/b/IIa/b clinical trials.
- (3+)-7 years of Clinical experience.
- Pharma experience preferred.

TECHNICAL COMPETENCIES:

- Understanding of project management, clinical regulatory requirements, and knowledge of GCP and ICH guidelines
- Working understanding of company infrastructure and processes is desirable eg SOPs, standards, goals and policies on business conduct.
- Scientific excellence
- Ability to review and understand emerging data and proactively instigate measures to ensure delivery of quality study results.
- Regulatory Documentation
- Good Clinical Practices (GCP)