Key Responsibilities:
Responsible for concept development and design of clinical trials andcontributes to the integration of clinical strategy into the overallclinical development plan.
Participate in or lead a matrixed clinical development team,responsible for the generation and maintenance of a scientifically soundclinical development plan aligned with regulatory and commercialstrategies and act as the primary clinical strategy representative onthe core project team and on safety/ risk management teams.
Responsible for clinical development aspects of project planning,protocol concept development and clinical trial design, generation ofstudy synopses, and assessment of clinical study results. Provideclinical review for study relevant documents such as protocols, clinicalstudy reports, Investigator Brochures and review study specific planscovering aspects such as data coding conventions and data reconciliationprocedures, statistical analysis plans and informed consent documents,and provide review of final study reports. Responsible for studyspecific medical responsibility plans to document medical monitoringactivities required for a specific study.
Contribute to the writing of clinical efficacy components ofregulatory dossiers through authoring key clinical sections and provideoversight to contributions from other stakeholders. Provide advice onthe clinical aspects of regulatory strategy in support of the filing ofINDs/CTAs and license applications throughout the development lifecycle.Lead/ contribute to the preparation of clinical sections for regulatorymeetings and attend and present at such meetings (e.g. pre-IND or endPhase 2 meetings/ Scientific Advice/ Advisory Boards) where required.
In collaboration with Clinical Operations, CRO and SAB identify keyinvestigators. Develop and maintain relationships with leadinvestigators within assigned therapeutic area. Additionally, activelyparticipate in investigator meetings.
Act as an internal clinical therapeutic expert developing andmaintaining an understanding of key disease states/etiology, treatments,therapeutic trends, competitive agents for the indications anddevelopment projects within the assigned therapeutic area.
Requirements:
Advanced degree (MD, PhD or PharmD) in life science/healthcare expected
＞10 years of Clinical development experience with a working knowledgeof pharmaceutical and regulatory development processes is essential.
Strong leadership and communication skills and a demonstrated abilityto develop constructive and effective relationships
Able to build and lead effective, well integrated, collaborative teams
Works successfully in a matrix organization with multiple disciplinesand to build collaborative relationships
Able to think globally and contemplate multiple aspects and impacts ofissues and plan proactively