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Late Clinical Development, Medical Director
4 months ago
The Late Phase 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 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 ( clinical input to (s)NDA/(s)BLA). The 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 Late 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 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
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 investigator and monitor training.
In partnership with the GCPL and/or GCH, lead the review and interpretation of clinical data (HLRs) and the development of content needed for governance committee interactions.
Support the development of clinical components of regulatory 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.
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 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 address impact on 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.
Ability to prepare and present clinical data and/or selected training sessions to internal/external groups
Ability to contribute to, and as needed, lead development of clinical reports and integrated summary reports for complex projects
Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees ( LSPC, DRC, PRC) or external groups ( Investigator Meetings, IDMCs, Conferences Presentations)
Required Qualifications for the Role
or MD./ degree or equivalent. Strong preference for individuals with clinical training in oncology
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) and other regulations governing clinical research
Possesses strong knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals
Strong leadership skills with the ability to influence others and drive consensus building
In Office Requirement :When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. This role can be aligned to Barcelona ES, Mississauga CAN, Warsaw, POL or Gaithersburg, MD, Waltham, MA or NYC. We can not support remote work or alternative work arrangements.
#lateclindevoncology
Date Posted
22-May-2024Closing Date
13-Jun-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.