Senior Global Development Scientist Director

The Senior Global Development Scientist Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT & GST members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. The Senior Global Development Scientist Director and counterpart Global Development Medical Director work collaboratively in the clinical aspects underpinning a clinical program. This includes the shared responsibility with Clinical Operations team members in the planning and execution, including recruitment and delivery of a clinical study. Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies. This includes 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 NDA/BLA).

The Senior Global Development Scientist Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross asset or cross tumor area working groups depending on the level of experience. As a key member of the clinical team, this position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca. 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. Depending upon experience level, the role will mentor the development of less experienced members of the clinical team, and may involve direct line management.

Responsibilities:

• 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 compounds/programs including scientific contribution to the Target Product Profile and participation in the preparation of clinical development plans.

• Provide expert clinical input to shape 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 and meets the strategic program objectives.

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

• Accountable for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans.

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

• Provides expert input into the development of the protocol and related documents (including, but not limited to, the ICF, CRF, TFL Shells, and Safety Reports).

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

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

• Support Health authority interactions as needed.

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

• May lead study level safety reviews

• May lead the study-level medical monitoring activities

• Contribute to the timely initiation and delivery of clinical trials in close collaboration with Clinical Operations and other CPT/GST members (including supply chain and sample management).

• Core member of the GST representing Clinical Development.

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

• Responsible for the clinical and scientific input into a study and for the quality of the clinical data.

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

• Contribute to advisory boards to ensure there is engagement with site specific KEEs to ensure robust study designs, recruitment strategies.

• Through a strong partnership with Clinical Operations (including Program Management, GSTs, SMM and investigational sites), proactively flag recruitment risks with proposed mitigations and support implementation of mitigations in a timely fashion.

• Proactively engage with MSLs to build strong partnerships with SMMs and KEEs to provide robust feasibility assessments and streamline study execution.

• Contribute to development and delivery of face to face or virtual investigator and monitor training.

• In partnership with the Global Medical Director, GCPL and/or GCH, lead the review and interpretation of clinical data (HLRs) and the development of content needed for governance committee interactions seeking Go/No Go decisions.

• Support the development of clinical components of regulatory and EC/IRB submission documents for instances where marketing approval is warranted. • Lead development and delivery of the clinical study report

• Work cross functionally in the preparation of launch & branding materials and publications.

• Serve as mentor of less experienced staff and may include the direct management of one or more staff Technical Skills

• Drug Development/Clinical Development Planning: Demonstrates a proven ability to both independently complete, and lead peers in completion in components of complex plans, related documents, appropriate methodologies, measures, analytical plans and evaluation tools.

• Ability to drive/contribute to protocol design, writing and implementation to meet GCP, ICH and all AZ quality standards.

• Ability to leverage state of the art methodology in the design, conduct, review and interpretation, and presentation of clinical research.

• Maintains a high degree of understanding and awareness of new and emerging clinical developments to impact specific studies and clinical development plans.

• Shows greater independence in the development of options for study design and development of the statistical analysis plan.

• Can lead the development of content and rationales in assigned sections of clinical reports or regulatory/EC/IRB documents.

• Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees (e.g LSPC, DRC, PRC) or external groups (e.g Investigator Meetings, IDMCs, Conferences Presentations)

• Strong leadership skills with the ability to influence others and drive consensus building

• Ability to contribute to, and as needed, lead development of clinical reports and integrated summary reports for complex projects

Minimum Requirements

• Required Life Sciences degree or equivalent

• PharmD, Ph.D. degree in life sciences, or MD preferred. Strong preference for Oncology experience

• Significant Industry or academic experience in drug development required.

• Possesses sound foundational knowledge of FDA and other major country regulations.

• Possesses detailed knowledge of Good Clinical Practice (GCP) other regulations governing clinical research.

• Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.

• Significant oncology therapeutic experience to be sought out or serve as a resource to other internal/external parties.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.