Clinical Strategy Lead (CSL)
The Clinical Strategy Lead provides strategic clinical directions for the life cycle of products as a representative of GCD (global clinical development). He or she will have clear awareness of priorities to align clinical resources and have a clear understanding of company’s current global investment in evidence collection as well as the company’s strategic goals.
· Responsible for developing "Global Clinical Evidence Plans" including short and long-term strategies, development of methodologically sound clinical study synopsis and clinical study plans with regulatory strategy and pathway, including product’s targeted indication, population, efficacy endpoint, and the competitive landscape.
· Serve as GCD representative for one or more franchise teams and actively participate in the respective regular franchise committee meeting and GCD meetings.
· Liaise with pre-clinical teams, medical information group, and clinical operation personnel, to ensure effective study alignment with product strategy throughout the design, implementation, and lifetime of the studies. As needed, participate in due diligence assessments of new product business opportunities.
· Provide updates of franchise needs and forecast resource demands to GCD management and clinical study teams.
· Work closely with the clinical study management), the data management group, and biostatisticians from study design to result report.
· Assist clinical study managers as needed in training investigators, research coordinators, CROs, central laboratories, and other study vendors on study procedures. Support scientific and professional meetings.
· Identify and establish professional relationships with KOLs, potential study investigators and professional organizations to support Global Clinical Plan development and maintenance.
· Provide insights to department SOPs and policies to identify and implement process improvements.
· Participate in internal/external GCD-related audits and regulatory inspections as needed. Implement appropriate corrective and preventative actions (CAPA), if necessary.
· Domestic or international travel up to 25% of the time.
· Doctor's degree or equivalent in bioscience related/healthcare field, or combination of equivalent education and experience in a medical or scientific setting. Additional training in clinical epidemiology preferred.
· A minimum of 5 years of experience in the pharmaceutical industry, clinical study-setting or scientific/research field required.
· Ability to handle complex projects, flexibility in managing priority changes, and skills in strategic thinking and problem solving.
· Skills in clinical study negotiation, English writing and verbal communication are required. Knowledge of industry standards and good practices in clinical data management, US Code of Federal Regulations, ISO 14155, ICH GCP are preferred.
· Supervisory experience is needed. The successful candidate would also need to possess experience in medical literature review and publication policies, experience with Clinical Trial Management Systems, Microsoft Access, Excel, Word, PowerPoint, Outlook, SharePoint, Visio, and Project. Experience with some statistical programs like SAS, STATA, and R is needed.