某biotech公司
medical director
生命科学
医疗
北京, 上海
10年以上
博士
面议
职位描述
Works hand-in-hand with the Chief Medical Officer to steer clinical strategies and their operationalization in programs and trials.
Drives the operational planning, content, execution and delivery for our programs and studies. Will manage day-to-day clinical activities for our clinical studies including management of protocol amendments, overseeing data review activities and communicating with investigator / sites where appropriate.
Collaborates with other development functions (e.g. Regulatory, Pharmacovigilance, Statistics, etc.) to support clarity on clinical objectives and drives alignment on objectives and expected outcomes
Responsible for trial medical/ safety aspects and risk-benefit assessments.
Develops Risk Management Plans.
Responsible for ongoing medical data review
Ensures on program (where appropriate) and trial level, that the clinical development team works hand-in-hand with Clinical Operations team for patient centric drug development, ensuring balancing of high medical quality, trial complexity, as well as time and cost considerations
Takes ownership together with other partner functions in Development on the acceleration of program and trial design and innovation for the patient
Creates input for clinical sections of key documents, including Investigator's Brochures, IND summary documents, CTAs, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs.
Ensures that the Clinical Study Report (CSR) medical content in assigned programs and trials meets high quality expectations on medical standards, provides respective guidance to other members of the clinical development team
Manages relationships with key external stakeholders (industry partners, Key Opinion Leaders, health authorities).
Represents the team to decision/governance meetings, senior management, or advisory boards as applicable.
Contributes to a collaborate culture within and outside Clinical Development and actively manages best practice sharing and capability building within the clinical team.
职位要求
M.D. and/or M.D. /Ph.D with strong scientific and clinical background in Hematology or Nephrology. Board certification in Oncology/Hematology or Nephrology preferred.
Minimum of 6 years of experience in a biotech/pharmaceutical setting, including leading clinical development activities, ideally from exploratory Phase I/II clinical trials through late stage development in Phase III and NDA/BLA submission.
Good understanding of the clinical and scientific methods and approaches used in clinical development, from FIH to registration; experience with regulatory processes and registration a plus.
Ability to write high quality and executable trial designs and protocols.
Hand-on experience in managing the ongoing clinical day-to-day work for the successful delivery of clinical trials.
Experience in liaising with clinical operations as well as with other functional groups on a regular basis for efficient clinical trial conduct.
Experiences in preparing and conducting global health authority interactions (e.g. NMPA, EMA, FDA). Having participated in drug development activities, leading to successful registration is an advantage.
Deep experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects
Ability to strategize clinical activities based on a TPP and CDP and translate into trial designs
Experiences with working in a matrix environment (global and cross-functional), including contributing to establishing clarity and structures and driving state of the art collaborations with external academic and industry partners.
Good understanding of the science supporting the clinical development programs. Confident to discuss and present scientific and mechanistic aspects of drug development.
Subject matter expertise on drug development topics, and genuine interest to drive innovation and continuous improvement
Proficiency in English (written and spoken)
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