Full-Time Global Clinical Lead Hematology
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Under the direction of the Hematology Group Head, the Global Clinical Leader (GCL) ensures that management goals and objectives are met. The GCL has a medical leadership role for a project or a portion of a project in clinical development, usually at the start of development through Phase 1-3. The GCL provides medical/scientific, technical, and managerial direction to the plans, programs, and procedures within his/her project and indication areas to effectively develop new compounds and/or oversee the optimization of a profile of existing compounds. Through the development of relationships with outside experts, organizations and agencies, and aligned with the goals of Business Development and Medical Affairs, the GCL uses his/her expertise and experience to support clinical development programs and licensed product maintenance. This includes the development of the strategy for clinical trials, assessing required resources and budget in collaboration with the Global Project Head, and establishing and maintaining a close relationship with other core team members and extended study teams to assure a closely coordinated program of activities based on common objectives.
Responsibilities include but are not limited to the following:
Global clinical development “point of contact” for the assigned therapeutic area within Hematology, responsible for the overall medical and scientific direction and support of product development from early research to post-launch.
Serve as an internal medical expert for products and disease-related content, pharmacovigilance teams, and assessment of in- and out-licensing opportunities of development projects.
Takes responsibility for projects assigned, including defining the targeted product profile, writing of the Clinical Development Plan, Pediatric Investigational Plan, clinical trial protocols, Annual Safety Report/IND Safety Reports, and Investigator Brochures and provides input and direction to data and statistical management plans.
Responsible for planning and managing the clinical timelines, managing clinical budget (including external clinical grants and CRO management fees) and manpower.
Contributes to planning of First in Man studies, determining clinical phase transition milestones, and analysis of incoming clinical data, initiating actions or decisions as appropriate.
Provides leadership in interactions with regulatory agencies. Contributes to submission strategy, regulatory dossiers, and medical oversight.
Serves as the chairperson of the cross functional Global Clinical or Study teams. Represents the Clinical and Study teams at the Global Project Team and other governing committees, as required for program performance.
Oversees and supports contacts to external experts, advisory boards, adjudication committees, and Data Safety Monitoring Boards.
Reviews and approves publications within the project, in collaboration with the Group head.
Identifies the need for studies to be conducted as Phase IIIb/IV jointly with Medical Affairs, and provides input to Medical Affairs on Scientific Platforms, Publication plans, and Product maintenance.
Assures adherence to governmental regulations, company SOPs, and compliance
Clinical/Technical Knowledge: Possesses strong knowledge of disease state with either extensive academic or professional experience.
MD, DO, MBBS or other graduate medical degree required.
Broad knowledge of Hematology. Board eligibility or certification in Hematology or Hematology/Oncology is desired, but not a must. A candidate with strong experience across multiple therapeutic areas may also be considered, particularly any expertise or experience in women’s health, hemoglobinopathies, and hemostasis/coagulation.
Champions new ideas and initiatives. Initiates bold, yet well-reasoned projects and manages them independently.
Shows Drive and Initiative. Readily puts in extra time and effort; tackles problems and works to resolve them without delay; establishes high standards of performance.
Approaches problems with curiosity and open-mindedness; creatively integrates different ideas and perspectives; stimulates creative thinking in others; generates innovative ideas and solutions to problems.
Makes timely decisions based on accurate logic; looks beyond symptoms to identify causes of problems; makes decisions in the face of uncertainty; takes all important issues into account.
Understanding of the drug development process with a base experience of 5 or more years in medical science and drug development. Needs knowledge of study design, protocol writing, study performance, data collection and interpretation, as well as experience with interactions with IRBs, ethics committees or regulatory agencies. Broad familiarity of drug development, regulatory requirements, payer landscape and life cycle management.
Flexibility and Relationship management
Experienced and adept at working collaboratively within a matrix environment with multiple departments, including basic science, manufacturing, and commercial teams.
Flexible and able to work on multiple projects with aggressive timelines.
Must provide clear vision, direction, and purpose in the different cultures present within the global organization.
Strategic and Tactical Excellence
Drives Execution: Creates plans that clearly define the organizations goals, milestones and results. Conveys clear expectations for deliverables; monitors progress of others and redirects efforts when goals are not being met; continually looks for ways to improve processes, products and services.
Executes responsibilities with knowledge, accuracy, persistence, resilience and creativity.
Establishes realistic plans, action steps and timetables for projects and assignments; identifies specific action steps and accountabilities; prepares realistic estimates of budget, staff and other resources.
Communication Skills: Strong communication skills to ensure that project plans and status are transparent. Effectively articulates ideas, opinions and information. Keeps people up-to-date with information; encourages others to express their views, even contrary ones; speaks and writes clearly and concisely.