The Clinical Research Director (CRD), Rare Blood Disorders Therapeutic Area, is responsible for creation and execution of the clinical development strategy for assigned projects in this Therapeutic Area (TA).
The CRD is expected to contribute to the growth of the Rare Blood Disorders TA by both being a driver of clinical and scientific knowledge and advancing operational capabilities by challenging “the status quo”.
Has and maintains deep scientific, technical and clinical expertise in the therapeutic area
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 within the Therapy therapeutic area to maintain credibility with internal and external stakeholders
Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes
Assessment of the Clinical benefit –risk profile during development and LCM on an ongoing basis, in strong collaboration with GPE and the CSO team
Provides clinical input to the Target Product Profile
Adjusts and updates the clinical strategy when necessary according to the project progression and information available
Contributes to the life cycle management strategy for the project whenever appropriate
Generates the Clinical Development Plan
Prepares the clinical part of meeting requests and briefing packages for meetings with Regulatory agencies
Generates the extended synopsis for clinical trials and reviews the protocols and protocol amendments prepared by the Clinical Study Director (CSD)
Writes or updates the clinical section of the Clinical Investigator Brochure and the clinical parts of the Clinical Trial Authorization dossier (IMPD, IND) in collaboration with the pharmacovigilance (GPE) department and the clinical pharmacologist
Reviews and when appropriate approves the committees charters
Prepares with the support of the medical writing department the summary of clinical efficacy and clinical overview of the Common Technical Document (CTD). Provide input and reviews all clinical sections of the CTD (clinical pharmacology, summary of clinical safety…) and other sections whenever appropriate
Prepares answers to questions from Regulatory Agencies on the clinical efficacy of the project and collaborates with GPE in preparing answers on the clinical safety of the project, collaborates on other sections whenever appropriate
In charge of the medical/clinical assessment of license-in opportunities
Reviews the Statistical Analysis Plans
For study protocols and Clinical Trial Authorization dossier, writes/reviews answers to clinical questions from Health Authorities and IRB/Ethics Committees
When appropriate collaborates with the CSD in preparing material for investigators meetings and in answering questions from investigators
Reviews the list of countries for clinical studies
Reviews Key Results Memos and Clinical Study Reports
Provide clinical input to and reviews the Risk Management Plan
Reviews scientific publications and communications on the project
Prepares and provides key medical information to internal people and external people
More than 5 years of clinical or scientific, or more than 10 years industry, experience within the field
Strong scientific and academic background with deep understanding of disease
Clinical research or pharmaceutical experience in the therapeutic area preferred
Knowledge of drug development preferred
Good networking ability in cross-cultural environment
Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization. Performance oriented and focus on strategy and execution
Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills
Fluent in English (verbal and written communication)
Shown below are the latest jobs from this category.
Human Resource Manager
Little Falls, NJ
Job Order: GD-715
Job Descriptions: In charge of employee relations which includes leading the social and recreation committee, organizing lunches, staff outings and year end parties. Develop other employee relation activities and enhancements. Be the point of contact for any staff related employee relation issues. Conduct “check-in” discussion with new employees...
Job Descriptions: Serve as a business partner with the on-site management team to effectively manage the Human Resources function while maintaining compliance with industry regulatory agencies and company programs Administer Staffing, Training, Employee Relations, Safety, Compliance, Benefits, Employee Retention, and Compensation programs at the local level and implement corporate-wide,...
Job Descriptions: Achieves territory sales objectives in all categories, including new product launches and increasing sales within the assigned territory. Maintains high retention rate of customer base through delivery of outstanding service and through effective analysis of the business needs of the customer. Develops a Monthly Business/Action Plan that supports the needs of their...
Job Description: Responsible to proactively develop innovative, robust US regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development for rare disease indications which adhere to US regulatory and company guidelines. Represent the NA GRA perspective as a member of project specific cross functional global regulatory team (GRT) and...
Central Florida, San Francisco, New Orleans,Arkansas
Job Order: GD-726
Job Description: Drive the success and growth of your sales region by generating leads vigorously and effectively. Meet with prospective and existing customers to provide product demonstrations and close on all product confidently. Cultivate early customer relationships for all company products. Participate in 3-5 weekly phone calls with Regional Sales Manager, RSM, (call objectives clearly...
Job Description: Proven ability to build strong relationship with internal customers, external customers, leasing agents, property managers, landlords, government agencies, and other stakeholders Excellent written and oral communication skills; ability to communicate appropriately with a variety of stakeholders Excellent organizational skills; ability to work under pressure, prioritize, manage...