Job Information
Sanofi Group Global Project Head, Hema-Oncology in Helena, Montana
Position Overview:
The Global Project Head for Early Stage Hema-Oncology Development is noted as the primary clinical/project lead for early stage programs focused on hematological malignancies .
The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.
Serve as Global Clinical Lead on multiple projects going to the clinic in the next months, including interleukins, immune-cell engagers, NK cells
Contribute to strategic and scientific discussions on all projects and technologies within the Oncology Early Development team
Act as a mentor for other CRDs and Clinical Scientists on the same project/therapeutic area
Collaborate with functions to ensure uniform, aligned operational approach (e.g harmonizing study documents, ES, protocols, etc). As relevant, within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to TA Heads, as relevant and shares relevant information within and beyond Project teams.
Take on as necessary the CRD role:
Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report)
Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)
Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities
Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data
Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps
Key responsibilities include:
Leading the clinical development plan strategies:
Internal Governance: Preparation of Documents and Presentations for Internal Governance Meetings
Take on as necessary the CRD role:
Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)
Collaborate with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams
Raise study or project-level issues to the project head
Contribute in the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects
Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators
Evaluates relevant medical literature and status from competitive products
Lead, Support and oversee the execution of clinical development and studies activities
Review and validate the clinical study report:
Develop the abbreviated protocol
Review and validate the final protocol and protocol amendments
Review the ICF WSI and TDF
Co-Develop the SAP in collaboration with bio stats
Responsible for key results preparation
Develop the clinical study report
Assisted by related functions (e.g. clinical operations, project management, and procurement), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
Medical support to clinical operation team during the clinical feasibility
Review and provide clinical input across different study documents CRF, e-diary, monitoring plan
Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with clinical scientist, bio stat and GSO
Lead the study specific committees (IDMC, steering com, adjudication …) with operational support
Answer to medical questions raised by EC/IRBs, sites
Responsibilities related to regulatory and safety documents and meetings: Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project Lead the strategy and structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Supports registrations, label submissions and modifications Take on as necessary the CRD role:
Review and/or contribute in the the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP
Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP
Ensures clinical data meets all necessary regulatory standards
Participates in Advisory Committee preparation
Scientific Data evaluation and authorship:
Participate and author manuscripts and abstracts
Support the planning of advisory board meetings
Establish and maintains appropriate collaborations with knowledge experts
Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams
Experience
Understanding of pharmaceutical product development and life cycle management gained through >4 years of development and medical experience in onco-hematology
Excellent Scientific and medical / clinical expertise
Excellent expertise in clinical development and methodology of clinical studies
Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
Demonstrated capability to challenge decision and status quo with a risk-management approach
Ability to negotiate to ensure operational resources are available for continued clinical conduct
Fluency in written and spoken English
Excellent Teaching skills, demonstrated ability to assist and train others
Ability to work within a matrix model
International/ intercultural working skills
Open-minded to apply new digital solutions
Minimum Level of any Required Qualifications:
Medical Doctor (MD): specialist in oncology or onco-hematology, English fluent (spoken and written)
5 + years in pharmaceutical industry or CRO, previous experience in clinical development in hematological malignancies
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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