R&D - Clinical Research Director - SH/BJ

JOB DESCRIPTION

Clinical Research Director

The Clinical Research Director (CRD) is noted as the primary clinical expert for programs.  The role requires a well-organized, strategic and operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.

The role of the CRD is to:

• Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps

• Take on as necessary the Associate CRD role:

• Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report)

• Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)

• Contribute to the Extended synopsis and Protocol for their project

• Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China andanswers to questions from health authorities

• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators

• Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data

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  Key responsibilities include:

  1.Leading the clinical development plan strategies:

  oResponsible for the clinical development plans and clinical sections of integrated development plans (IDP)

  Collaborate with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams

  Raise study or project-level issues to the project head

  oContribute in the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects

  oCollaborate with external partners, regulators, and diverse internal stakeholders and collaborators

  oEvaluates relevant medical literature and status from competitive products

  2.Lead, Support and oversee the execution of clinical development and studies activities

  oReview and validate the final protocol and protocol amendments

  oReview the ICF WSI and TDF

  oAssisted by related functions (e.g. clinical operations, project management, and procurement), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)

  oLead the study specific committees (IDMC, steering com, adjudication …) with operational support

  oCo-Develop the SAP in collaboration with bio stats

  oResponsible for key results preparation

  oDevelop the clinical study report

• Raise study or project-level issues to the project head

§Develop the abbreviated protocol

§Develop the final protocol and protocol amendments

§Medical support to clinical operation team during the clinical feasibility

§Review and provide clinical input across different study documents written subject information, CRF, e-diary, monitoring plan

§Medical support to clinical operations team on study plans: CMP/MRP, DR & DS review

• Raise study or project-level issues to the project head

§Participate in the elaboration of training material and presentations at the investigator meetings

§Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with operational support, bio stat and GSO

§Answer to medical questions raised by EC/IRBs, sites

• Support CRD trial master file documents readiness and availability, and mandatory trainings linked to the clinical function

• Collaborate and communicate appropriately with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs), including but not limited to:

• • feasibility managers for feasibility preparation and validation of feasibility results

  • Medical Writers to develop, review and finalize WSIs, study protocols and reports

  • Clinical Scientists, Medical review team and Coding

  • Pharmacovigilance (GSO, CME)

  • CTOMs, Biostatisticians

  • CSU medical advisors for the best knowledge of the study, compound, protocol

  • TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs

  • CROs

  • Regulatory affairs

• Collaborates with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to the global project head and clinical lead

• Provide operational expertise to project clinical sub team, as needed

3.Responsibilities related to regulatory and safety documents and meetings:

oReview and/or contribute in the the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP

oContribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP

oEnsures clinical data meets all necessary regulatory standards

oParticipates in Advisory Committee preparation

4.Scientific Data evaluation and authorship:

oParticipate and author manuscripts and abstracts

oSupport the planning of advisory board meetings

oEstablish and maintains appropriate collaborations with knowledge experts

oContribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams

Experience

oUnderstanding of pharmaceutical product development and life cycle management gained through ~6 years of development and medical experience

oVery good Scientific and medical/clinical expertise

oVery good expertise in clinical development and methodology of clinical studies

oVery good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies

oDemonstrated capability to challenge decision and status quo with a risk-management approach

oAbility to negotiate to ensure operational resources are available for continued clinical conduct

oFluency in written and spoken English

oVery good teaching skills, demonstrated ability to assist and train others

oAbility to work within a matrix model

oInternational/ intercultural working skills

oOpen-minded to apply new digital solutions

Minimum Level of any Required Qualifications: 

• At least 6 years of experience in Clinical Drug Development for a large pharmaceutical or a biopharmaceutical company

• Strong medical background particularly within the therapeutic domain, background in Hametology and Neurology will be perferred  

• Excellent understanding of the drug development processes and the regulatory framework for clinical trials.

• Strong team player with Experience in leading multiple, diverse clinical development programs. 

• Strong verbal and written communication skills, fluency in English, ability to work transversally

• Ability to interpret clinical data accurately

• Good understanding of biostatistics, pharmacokinetics, regulatory environment (China and Worldwide)

• Ability to analyze and summarize scientific and clinical data and develop recommendations that affect the conduct of studies and the content of regulatory submissions.

• Cross-cultural experience in Clinical Drug Development

• Quality and Compliance oriented

• Ability to drive change and innovation

• Ability to work independently and think strategically

• Result-oriented and decision-making mindset

• Behavioral excellence