Primary leader oversees overall development strategy, and execution accordingly
Take lead in Clinical Development Activities related to products, protocols or studies.
Serve as a scientific, medical accountable person for quality and timely delivery
Actively participate in regulatory strategy formation.
Active participation of regulatory agency consultation, meanwhile oversight preparation and completion clinical dossier
Serve as HMPL clinical representative to external partners
Establish and liaise with medical community, institutions, key investigators, deeply involve in Investigator selection in HMPL development programs.
build and expand KOL pool, work with commercial on scientific key messages, launch plan and input on product life cycle management
Completes tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience.
Analyze, interpret, active present clinical trial results.
Supervise and lead the study conduct.
Assure that results meet the high standards of quality.
Support the clinical strategy for a project through Clinical development, in partnership with relevant matrix team members.
Contribute to achieving project goals and effectively influence individuals to accomplish objectives in a matrix team environment.
Be a scientific/medical reference for the assigned products, protocols or studies.
Serve as a key knowledge source for internal stakeholders including Country Medical.
Department staff regarding study data, to be utilized in communication media and in documents for the specific disease area.
Participate effectively in meetings, ensure interface with all departments involved in the project. Represent the client through contact with Health authorities, KOL, Universities, and CRO’s.
Participate and interface with the publication strategy team.
Interpret complex clinical data and experimental results.
Provide accurate and appropriate medical/scientific input into components of clinical development plans: draft protocol, population selection methodologies, outcome measures etc. This may require specific independent research and investigation (literature reviews, consultations, interviews…) to accomplish this objective.
Actively participate as a core member of the clinical project team and contribute to achievement of team objectives.
Prepare expert reports, including the IB and clinical study report.
Support RA during registration process.
Contribute to development of summary documents (Safety, Efficacy, Marketing, Approval)
A MD level is mandatory.
Proven expertise in clinical research (around 5 years) with international Good Clinical Practice.
Guidelines, basic knowledge of human experimentation laws and regulations.
Experience in Oncology in an asset, experience in medical cleaning of large data set is also an asset. At least one previous experience in oncology is highly recommended.
Basic mastery of statistics applied to clinical research.
Potential to develop capability to manage people and budget, starting level of mentoring or small teams under stress.
Good ability to interpret complex clinical data and experimental results.
Ability to develop network internally and externally to communicate in situations requiring special tact and diplomacy.
Excellent English (writing and speaking) and excellent mastery of English medical terminology.