Senior Manager, Clinical Operations Lead - United Kingdom
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|External Posting Title||Senior Manager, Clinical Operations Lead|
|Job Description||Partners with the Study Lead Scientist (e.g. Medical Director, Pharmacologist, Biomarker Science Leader) and other functions to develop operationally feasible and clear protocol concepts and final protocols. Leverage early phase operational expertise to establish study level operational strategy in alignment with the Clinical Development Plan (CDP) and program level operations strategy. |
Independently oversees and leads one or more early phase clinical studies by establishing the operational strategy and securing excellence in execution and delivery through the CROs and vendors.
Identifies strategic operational approaches that span program(s) partnering with the AD ECDOL and drives the evaluation and implementation as appropriate.
Positively impacts the performance of other Early Development Operations Study Leaders by, for example, initiating and leading discussions at peer level forums relevant to the Sr ECDOL role and development in line with Early Clinical Operations best practices.
Ensures delivery of early phase clinical studies (Scientific Research Collaboration (SRC), clinical pharmacology, Phase 0, Phase 1/1b and phase 2 through POB/POC) on time, with high quality and within agreed budget by:
• Partnering with the Study Lead Scientist and other functions to develop scientifically robust, operationally feasible and clear protocol concepts and protocols.
• Utilizing operational expertise and scientific assessment to evaluate study feasibility.
• Developing study operational strategy and risk mitigation plans in alignment with the clinical development plan and program operations strategy.
• Define and implement the sourcing strategy for the study.
• Leading/chairing the cross-functional Study Management Team and ensuring that all the supporting functions across Biogen involved in the planning and implementation of the study are effectively contributing to study delivery; ensuring the proactive identification and resolution of issues across those functions.
• Overseeing the tactical execution of the study operational strategy by the CRO(s).
• Selecting the study sites and strategically building strong relationships with investigators and investigational site staff.
• Building a rich knowledge of specific Area(s) of Expertise specific to the conduct of early phase clinical studies. They are a mentor / SME for the Early Clinical Operations group and leveraged by other groups within ECD and across Development Sciences for their early phase operational expertise.
Strives for effective, fit for purpose, efficient and compliant processes by:
• Leading and/or contributing to the functional initiatives within ECO, ECD and Dev Sci.
• Following established procedures and SOPs while seeking ways to improve and adapt processes to support the conduct of different types of studies within the early phase space.
• Embodying a culture of continual improvement and innovation by actively seeking new ways of working more efficiently to meet the needs of Early Clinical Development.
• Championing best practice development in the planning, conduct and reporting of early phase clinical studies and seeking opportunities for innovation and efficiency within the Early Clinical Operations group by actively sharing knowledge and experience
• Seeking inter-dependencies and synergies with other trials and programs to enhance superb planning and execution across studies in Early Clinical Operations.
|Job Category||Clinical Operations|
• At least 8 years of clinical research study/project management experience, some of which must be in early development. Prior CRO or investigator site and/or monitoring experience is a plus.
• Good general knowledge of clinical development with a good understanding of the early clinical development phase including its objectives and specificities.
• Interested in science and able to scientifically understand protocols.
• Ability to establish study operational plans and to ensure their execution by leading the cross-functional team and overseeing the CROs and vendors. Requires a balance of scientific and operational/project management and team leadership expertise. Must be able to build effective relationships across and up and down the organization.
• Ability to adapt to different operating models and to quickly shift strategy based on new information.
• Inquisitor and comfortable with the unknown.
• Ability to leverage rapid turnover of studies.
• Ability to operationalize studies with new indications or patient populations, novel endpoints and new procedures.
• Ability to influence the Lead Study Scientist on clinical study direction based on changing internal and external landscapes within a disease or therapeutic area
• Excellent project management skills, including risk assessment and contingency planning.
• Able to partner with other functions and both internal and external stakeholders.
• Excellent leadership, communication, and organizational skills, along with problem solving, conflict resolution, and team building skills.
• Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
• B.A. or B.Sc. in a scientific discipline; advanced degree preferred.
• Scientifically and clinically astute with very strong project management skills.
|About Biogen||Corporate Overview|
Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek’s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science’s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.
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