Sr. Global Medical Director, Oncology, Late Clinical Development

The Senior Global Development Medical Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally, in a matrixed environment, with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel.   The Senior Global Development Medical Director and counterpart Global Development Scientist work collaboratively in the clinical aspects underpinning a product.  Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies, including providing clinical input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to (s)NDA/(s)BLA).  The Senior Global Development Medical Director plays a critical role in the medical monitoring of a clinical study ensuring safety to patients. They share responsibility with Clinical Operations team members in the planning, execution and closure of a clinical study.

The Senior Global Development Medical Director is responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety. The Senior Global Development Medical Director may also provide expert input or lead functional process improvement initiatives and provide expert contributions to cross asset, cross tumor working groups or cross Therapy Areas, depending on the level of experience. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements.  Senior Directors will mentor the development of less experienced members of the clinical team.

Clinical Development Responsibilities/Accountabilities:

• Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety.

• Work cross functionally within clinical product teams (CPT) to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents (such as Global ICF, CRF, TFL shells, etc). 

• Significant contributor to the development of program strategy for assigned compound(s)/programs including scientific contribution to the Target Product Profile and participation in the preparation of clinical development plans. 

• Provide expert clinical input to influence the study design via collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders, such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements, inform recruitment strategies and meets the strategic program objectives.

• Responsible for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation.

• Work with GPT/CPT members to develop a compelling business case for governance approval. 

• Participate or lead as needed the review and assessment of new opportunities and ESRs.

• Accountable for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans (including, but not limited to, the ICF, CRF, TFL Shells, and Safety Reports).

• Responsible for the delivery of final protocol and its governance approval. 

• Supports or leads interactions with global medical affairs, marketing companies, commercial, and regulatory functions in collaboration with GCH/GCPL to ensure cross functional input into protocols. 

• In partnership with GCPL, and/or GCH drive work required for technical review of protocols with governance bodies such as DRC and PRC. 

• Support Health authority interactions as needed. 

• May lead the development and approve the Medical Oversight Plan (MOP)

• May lead study level safety reviews amd medical monitoring activities

• Core member of the GST representing Clinical Development.

• Responsible for the clinical input into Feasibility Questionnaires and consulted on country and site selection

• Assures oversight of collected data, monitoring safety and efficacy within a study.

•  Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests

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