Global Development Medical Director, Cell Therapy Oncology

AstraZeneca•Cambridge, MA

6d•$249,827 - $374,741•Hybrid

About The Position

The Global Development Medical Director is an important part of the Clinical Project Team (CPT) and Global Study Team (GST), working collaboratively and cross-functionally in a matrix environment with other CPT, GST, and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. This role, along with the Global Development Scientist counterpart, focuses on the clinical aspects underpinning a product. Accountabilities include clinical support for the development and implementation of late-phase AstraZeneca-sponsored clinical program strategies. This involves providing clinical input into the design and implementation of clinical trials, their delivery, clinical data review, interpretation of results, timely reporting, and activities required for worldwide registration of the product (i.e., 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 patient safety. They share responsibility with Clinical Operations team members in the planning, execution, and closure of clinical studies. The role is responsible for ensuring the risk-benefit of a clinical study, ensuring all clinical studies operate to the highest ethical and safety standards and comply with FDA, EMEA, ICH, and GCP guidelines, as well as SOPs regarding safety. Depending on experience, the Global Development Medical Director may also provide expert input or lead functional process improvement initiatives and contribute to cross-asset, cross-tumor working groups or cross-Therapy Areas. This position demands strong collaborative communication skills, the ability to engage with and influence diverse collaborators within and external to AstraZeneca, and adherence to the highest ethical standards in compliance with internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements. Depending on experience level, the role will mentor the development of less experienced members of the clinical team.

Requirements

MD./Ph.D. degree or equivalent with industry or academic experience in drug development
Possesses detailed knowledge of Good Clinical Practice (GCP) and 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.
Ability to grow and maintain a high level of expertise in oncology therapeutic area.
Demonstrates the ability to undertake the planning, and timely organization of components of the clinical development plan and work with other functions to achieve successful study initiation and execution.
Ability to drive/contribute to protocol design, writing and implementation to meet GCP, ICH and all AZ quality standards.
Demonstrates solid understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research.
Can conduct literature reviews to inform protocols, and author background sections on the disease or current medical therapy.
To provide clinical input into options for the study design and development of the statistical analysis plan.
To effectively organizes content and rationales in assigned sections of clinical reports or regulatory/EC/IRB documents (i.e. CTA, briefing book, BLA/NDA).
Ability to prepare and present clinical data and/or selected training sessions to internal/external groups.
Ability to contribute to clinical reports and integrated summary reports.
Emerging communication & presentation skills including the ability to clearly communicate scientific concepts/data to leadership committees (e.g LSPC, DRC, PRC) or external groups (e.g Investigator Meetings, IDMCs, Conferences Presentations).
Emerging leadership skills with the ability to influence others and drive consensus building.

Nice To Haves

Strong preference for individuals with clinical training in oncology

Responsibilities

Responsible for evaluating the risk-benefit of a clinical study. Ensure all clinical studies follow rigorous ethical and safety principles. They must follow FDA, EMEA, ICH, and GCP guidelines, as well as SOPs related to safety.
Work with clinical product teams (CPT) to develop the study concept document, protocol, and related documents.
Develop relationships with appropriate consultants and key external experts (KEE), study sites, and utilize these relationships to obtain feedback on protocol design, as well as study training, study execution, and interpretation of study results, and inform recruitment strategies.
Responsible for the relevance and accuracy of clinical science underpinning 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 (including, but not limited to, the ICF, CRF, TFL Shells, and Safety Reports).
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.
Contributes to technical review of protocols with governance bodies such as DRC and PRC.
Support Health authority interactions as needed.
Contribute to the development of Medical Oversight Plan (MOP), study level safety reviews, and study-level medical monitoring activities.
Core member of the GST representing Clinical Development.
Clinical input into Feasibility Questionnaires and consulted on country and site selection.
Assure 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 and 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 submission documents for instances where marketing approval is warranted.
Development and delivery of the clinical study report.
Work cross functionally in the preparation of launch & branding materials and publications.
Where appropriate, serve as a mentor of less experienced staff.