Director, Clinical Scientist, Immune/Inflammatory

Role Summary

The Director Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Director leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Director reports to the Senior Director Clinical Scientist and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs.

Responsibilities

• May function as lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist
• Member of the Clinical Study Team and Global Clinical SubTeam
• Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments
• Maintains advanced understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape
• Applies advanced scientific expertise to propose, design, and execute clinical research and development studies for early and/or late stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature
• Develops the Expanded Synopsis and authors clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments
• Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and resolve cross functional comments independently
• Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
• Independently leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal stakeholders
• Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
• Applies advanced analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies
• Ensures consistent first line medical/clinical data review techniques and conventions across studies/programs; leads drafting/updating/review of clinical data review plan and medical monitoring plans; ensures execution where appropriate for assigned studies/program
• Identifies areas of potential inconsistent data review across assigned clinical research program(s) and implements solutions and/or escalates as appropriate
• May serve as a peer coach and/or mentor and provides guidance to junior members of department and cross-functional team members as appropriate

Qualifications

• Required: BS/MS/PhD/PharmD and ≥ 10 years of pharmaceutical clinical drug development experience.
• Required: Demonstrates advanced knowledge of the global drug development process, Good Clinical Practice, complex study design, clinical research methodology and medical writing skills.
• Required: Extensive knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines.
• Required: Proven track record in clinical trial process improvements.
• Preferred: Experience in managing cardiovascular and/or metabolic and/or immune/inflammatory related clinical trials.

Skills

• Cross-functional collaboration and matrix leadership
• Strong scientific and analytical capabilities to design, execute, and interpret clinical studies
• Experience with clinical data review, medical monitoring plans, SAPs, informed consent forms and clinical study reports
• Regulatory writing and interaction with regulatory authorities
• Data risk assessment and mitigation planning
• Mentoring and coaching junior staff

Education

• BS/MS/PhD/PharmD or equivalent