Company
pharmaceutical
Director,ClinicalProgramLead
Neural analysis suggests this role is
optimal for Director candidates.
“Director, Clinical Program Lead. Skills: Clinical development strategy, Clinical trial execution, Regulatory submissions, People management. Leads China clinical development strategy and delivery, as part of global early development. Ensures that early oncol clinical trials for their program are designed and executed to the highest scientific and quality standards, and are focused on addressing the relevant technical and/or business objectives”
What You'll Achieve.
Delivery of clinical trials in line with agreed timelines; High scientific and quality standards in clinical trials; Addressing relevant technical and/or business objectives; Timely production and approval of quality clinical deliverables
Industry & Context.
Identifies and assesses program risks; Creates, implements and assesses effectiveness of mitigation plans; Resolution of clinical queries from drug regulatory agencies
What They're Looking For.
Must Have
Proven track record of being a successful Study Clinician (preferably in late phase development, or post-approval, as applicable to role)
Nice to Have
Postgraduate training/certification/fellowship in a medical discipline or in drug development, Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.), Thorough understanding of local/ international regulations applicable to clinical trials (pre and post approval), Experience in pharmaceutical industry as people manager of clinical colleagues
What You'll Do.
Leads China clinical development strategy and delivery
as part of global early development
Ensures that early oncol clinical trials for their program are designed and executed to the highest scientific and quality standards
and are focused on addressing the relevant technical and/or business objectives
Accountable for negotiating milestones and ensuring delivery of clinical trials in line with agreed timelines
Identifies and assesses program risks
implements and assesses effectiveness of mitigation plans
Performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk lead
Responsible for identifying emerging safety trends and raising them forward for further discussion
Contributes to clinical preparation for and attends meetings with regulatory agencies and the resolution of clinical queries from drug regulatory agencies
Maintains disease area knowledge relevant to their program
in particular with regards to design and outcome of clinical trials for competitors
Responsible for operational excellence and timely production and approval of quality clinical deliverables for their program
contributions to the clinical plan and regulatory submissions/documents
and manuscripts intended for external publication
Ensures appropriate medical and scientific expertise from different countries and regions is consistently brought to all clinical program strategy
execution and interpretation activities
Involves internal experts and consults with relevant technical advisory committee(s) to ensure high quality protocol designs and efficient clinical development plans
Provides clinical leadership on Phase 3b/4 programs regarding Scientific and Commercialization Support (SCS)
product defense and clinical consultation on Epidemiology and Outcomes Research studies
Maintains a productive
collaborative relationship with a broad group of internal stakeholders
Plans resources required for elements of program under his/her responsibility
in order to accomplish the clinical objectives in a timely and resource-efficient fashion
Responsible for the development
retention and engagement of clinical colleagues reporting to them
Ensures technical excellence and functional competency of Study Clinicians who report to them
performance management and training
Keeps Category Development Lead informed of clinical progress and any critical clinical issues
especially those impacting the emerging benefit: risk profile
May support technical review of licensing opportunities
including due diligence activities
Ensures compliance with global and local training requirements and adherence to relevant global / local clinical and medical controlled documents (CMCDs) assigned to them and to the clinical colleagues reporting to them
May present to senior management
governance committees and external audiences on the clinical aspects of compound development
Contributes to (or leads) continuous improvement activities
and to education and training of clinical staff in areas of competence/experience
How You'll Work.
Team & Collaboration
Effective collaboration with colleagues in relevant Global Clinical function; Maintains a productive, collaborative relationship with a broad group of internal stakeholders (e.g. Medical, Statistics, Clinical Pharmacology, Portfolio and Project Management, Clinical Trial Management, Pharmaceutical Sciences, Safety, Regulatory etc.); Involves internal experts and consults with relevant technical advisory committee(s)
Communication Scope
Communication with regulatory agencies; Present to senior management, governance committees and external audiences
Process & Methodology
Clinical program management, Negotiating milestones, Ensuring delivery of clinical trials in line with agreed timelines, Resource planning, Timely production and approval of quality clinical deliverables
Full Job Description
**Responsibility:** -· Leads China clinical development strategy and delivery, as part of global early development. · Ensures that early oncol clinical trials for their program are designed and executed to the highest scientific and quality standards, and are focused on addressing the relevant technical and/or business objectives. · Accountable for negotiating milestones and ensuring delivery of clinical trials in line with agreed timelines. · Identifies and assesses program risks; creates, implements and assesses effectiveness of mitigation plans. · As delegated by Category Development Lead, may lead development of and adherence to Safety Review Plan (SRP). Consistent with SRP, performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk lead. For all studies, clinical safety review should be performed in consultation with a designated medically-qualified Medical Monitor. · Responsible for identifying emerging safety trends and raising them forward for further discussion with Category Development Lead and/or medical monitor as appropriate. · In collaboration with Category Development Lead and Onc Dev colleagues, contributes to clinical preparation for and attends meetings with regulatory agencies and the resolution of clinical queries from drug regulatory agencies. · Maintains disease area knowledge relevant to their program, in particular with regards to design and outcome of clinical trials for competitors. This may include responsibilities for clinical expert panel meetings and advisory boards to give input on clinical plans. · Responsible for operational excellence and timely production and approval of quality clinical deliverables for their program, including protocols, study reports, contributions to the clinical plan and regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR), and manuscripts intended for external publication. The China Clinical Program Lead provides final sign off for do
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