The Senior Clinical Research Director (Senior CRD) in Immunology & Inflammation Therapeutic Area, is responsible for contributing to and overseeing the creation and execution of the clinical development strategy across indications in the project. The Senior CRD is expected to contribute to the growth of the project and the Immunology & Inflammation TA by both being a driver of clinical and scientific knowledge and advancing operational capabilities by challenging “the status quo”. As a member of the core project team the Senior CRD is responsible to expand the strategic plan for the development and to translate it into a clinical program with the goal of successful registration and commercialization. The Senior CRD is also responsible to align the I&I strategy and execution for with other therapeutic areas involved in the development of the program.
Based upon an in-depth scientific understanding and extensive clinical experience, the Senior CRD is responsible for:
As leader of clinical subteam in the project team to set strategic directions for the compound and translate those into a clinical program.
To guide program through internal decision processes and regulatory authority meetings, and to incorporate pertinent feedback into program.
To guide indications selection and translation into clinical program, develop CDP and other strategic documents.
To deliver successful regulatory approvals.
To manage a team of clinical directors to deliver clinical studies on time and budget with high quality and in compliance with internal SOPs, GCP, ICH guidelines and other regulations and produce high quality regulatory and other documents.
To coach internal clinicians to become experts in pharmaceutical drug development and incorporate academic knowledge.
To maintain or establish strong interaction with external scientific and clinical communities to advance scientific and clinical knowledge in the therapeutic area and to create novel approaches for drug development.
To Work cross-functionally with other key stakeholder functions such as Research, Translational Medicine, Regulatory, Safety, Value & Access, Commercial, etc.
To apply high ethical standards and work with integrity.
Scientific and Technical Expertise:
This position requires a strong scientific and clinical foundation in Immunology therapeutic areas including dermatology, rheumatology, and/or respiratory. It requires knowledge in metabolism as well as in all aspects of drug development. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.
Has and maintains deep scientific, technical and clinical expertise in pertinent medical disciplines and related areas.
Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest.
Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products.
Maintains visibility and leadership within the Immunology & Inflammation Therapeutic Area to maintain credibility with internal and external stakeholders.
Ensure that all development activities are proactively planned and targeted towards timely achievement.
Interacts with opinion leaders and consultants.
Overseas individual CRDs who are accountable (in collaboration with Project Team) for study development, execution, and analysis.
Influences the definition of the product value proposition (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.
Complex Problem Solving:
As CDPs are sophisticated documents that require the ability to integrate highly complex scientific, medical and operational information, strong scientific, medical and analytical skills are required.
An innovative and open-minded approach to problem solving is critical to arrive at the optimal solution for complex development challenges.
Represents the project at key regulatory agency meetings as the medical spokesperson for the project.
Ensures clinical data meets all necessary regulatory standards.
Supports registrations, label submissions and modifications.
Participates in Advisory Committee preparation.
Scientific data dissemination:
Ensures timely submission and dissemination of clinical data.
Supports the planning of advisory board meetings
Establishes and maintains appropriate collaborations with knowledge experts.
In addition to the above activities the Senior CRD must ensure that all activities of the Global Project Team are conducted in compliance with current regulations, laws and guidance from FDA, EMA, and CHMP, as well as with Sanofi’s policies and procedures.
Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME).
More than 5 years of clinical or scientific, or more than >10 years industry, experience within immunology drug development.
Specialist training in dermatology, rheumatology, pulmonology, or allergy.
Strong scientific and academic background with deep understanding of the disease.
Good networking ability in cross-cultural environment.
Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization.
Performance oriented with ability to work along agreed timelines and a focus on strategy and execution.
Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills.
Fluent in English (verbal and written communication).
LOCATION: open to applicants on East Coast, West Coast and Europe
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.
Internal Number: R2586105
Sanofi S.A. is a French multinational pharmaceutical company headquartered in Paris, France, as of 2013 the world's fifth-largest by prescription sales. The company was formed as Sanofi-Aventis in 2004 by the merger of Aventis and Sanofi-Synthélabo, which were each the product of several previous mergers. It changed its name to Sanofi in May 2011.
Sanofi engages in the research and development, manufacturing and marketing of pharmaceutical drugs principally in the prescription market, but the firm also develops over-the-counter medication. The company covers 7 major therapeutic areas: cardiovascular, central nervous system, diabetes, internal medicine, oncology, thrombosis and vaccines (it is the world's largest producer of the latter through its subsidiary Sanofi Pasteur).