Director, Clinical Program Lead

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 documents generated by Study Clinician(s) when supervising their activities.
• Through effective collaboration with colleagues in relevant Global Clinical function, ensures appropriate medical and scientific expertise from different countries and regions is consistently brought to all clinical program strategy, design, 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 that reflect Enhanced Clinical Trial Design (ECTD)/ Enhanced Quantitative Drug Development (EQDD) principles, current disease area knowledge, and incorporation of all relevant elements of the Understand and Deliver decision-making framework for their program.
• Provides clinical leadership on Phase 3b/4 programs regarding Scientific and Commercialization Support (SCS), co-promotion, product defense and clinical consultation on Epidemiology and Outcomes Research studies.
• 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.).
• 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, through oversight, coaching, mentoring, 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, including milestones, strategies and data, as appropriate.
• Contributes to (or leads) continuous improvement activities, and to education and training of clinical staff in areas of competence/experience.
Qualifications (Training, Education & Prior Experience):
Education
• Required: M.D., Ph.D., D.V.M., M.S., and/or PharmD or equivalent qualifications.
• Preferred: Postgraduate training/certification/fellowship in a medical discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, et c.).
Experience
• Required: Proven track record of being a successful Study Clinician (preferably in late phase development, or post-approval, as applicable to role).
• Preferred: Thorough understanding of local/ international regulations applicable to clinical trials (pre and post approval). Experience in pharmaceutical industry as people manager of clinical colleagues.
Work Location Assignment: On Premise
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