The Associate Director/Director, Clinical Development will be based in either Gaithersburg, Maryland or Cambridge UK, and reports to the Director/Sr. Director, Clinical Development, Cardiovascular/Metabolism.
This is a unique opportunity to join MedImmune at a time of tremendous growth and acceleration in the Chronic Kidney Disease (CKD) biologics portfolio. This is a fast-paced and dynamic work environment where, with increasing levels of responsibility, this individual will be responsible for medical monitoring of ongoing clinical trials, the planning and conduct of clinical trials, providing long-range clinical development planning, planning and managing of clinical research projects and clinical development programs in the field of CKD, collaborating with and providing clinical input and expertise to pre-clinical and translational sciences, and setting and achieving goals and meeting timelines in accordance with corporate goals and budgets.
S/he will serve as the project Medical Monitor while working in a cross functional environment with representatives from other involved line functions as well as Late-Stage Development. S/he will contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
Major Duties and Responsibilities:
We are seeking a well-trained clinician with strong leadership skills who is driven by science and the desire to develop novel therapies for patients with CKD. This individual will have the opportunity for growth and development while working in a vibrant environment and “biotech” culture.
The ideal candidate will have a clear understanding of the drug development process (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully.
Specific duties and major responsibilities include:
- Serves as medical monitor with primary responsibility for patient safety and conduct of assigned trials as well as overall data interpretation and safety surveillance.
- Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports. Responsible for assisting in design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds or indications in light of developments in the area of clinical and pharmaceutical Nephrology.
- Collaborate with pre-clinical and translational sciences, and senior management in assessing requirements for emerging products.
- Provide leadership on cross-functional product development team(s) as experience allows.
- Participate in identification, selection and conduct of negotiations with clinical research centers and investigators.
- Participate in the selection and management activities of ARO’s and CROs.
- Supervise project team members in planning, conducting and evaluating clinical trials. Oversee planning and management of investigator meetings, advisory boards and other scientific committees.
- MD required with a current medical license preferred.
- Medical specialty and sub-specialty training and certification (or eligibility) are highly desirable in Nephrology.
- Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in Nephrology is required.
- CKD development experience desirable.
- Experience in translational science preferred.
- Associate Director: At least 1-2 years of experience in clinical research and/or CKD drug development in an academic, pharmaceutical or CRO environment.
- Director: At least 2-5 years of experience in clinical research and/or CKD drug development in pharmaceutical or CRO environment.
Special Skills/Abilities (for Associate Director and Director except where noted):
- Excellent oral and written skills, strong interpersonal and listening skills
- Results driven to achieve creative and sound outcomes
- Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment.
- Ability to make sound and timely decisions; agile in learning and action oriented
- High level of emotional intelligence; able to deal with ambiguity
- Able to relate to varied level audiences across the organization; able to set priorities for team and maintain accountability; skillful in negotiating organizational boundaries and hierarchy; able to build effective teams; experience managing and developing others (Director only)
Job Complexity: High
Associate Director: Able to act independently with minimal supervision in many situations but may require moderate supervision on complex issues. Able to make most medical decisions with minimal consultation but will require moderate supervision on complex medical decisions.
Director: Able to act independently with minimal supervision. Able to make medical decisions with minimal supervision.
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