Associate Director, Clinical Scientist

Adaptimmune Therapeutics Plc Philadelphia , PA 19107

Posted Yesterday

Associate Director, Clinical Scientist

  • Philadelphia, PA

  • Full Time

  • Clinical Operations

  • Senior Manager/Supervisor

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Job Summary

The Associate Director level Clinical Scientist role is a global role, based in either the US or the UK. The role provides scientific input and oversight, as well as leadership and management of cross-functional execution of clinical studies, within Adaptimmune's programs.

The Clinical Scientist will be responsible for global clinical trial delivery including the planning, management and reporting of trials in accordance with company plans/objectives, GCP, local country requirements and company standard operating procedures. This includes writing and/or reviewing protocols, interacting with sites for feasibility assessment, site selection, start up, study conduct, data cleaning, data review, and study close-out, for one or more clinical trials.

Responsibilities and Duties

  • Support study design, translate scientific imperative into operational delivery of trials. Review and/or writing of study concept, protocol, study plans, IP management plans, CSRs

  • Lead the cross-functional Study Conduct Team drive operational delivery and facilitate issue resolution

  • Plan timelines, conduct study feasibility, risk assessment/management and contingency planning. Ensure timelines are communicated to all personnel assigned to the study (including vendors)

  • Plan and/or conduct site evaluation and initiation; develop and maintain effective relationships with clinical sites globally

  • Provide guidance on protocol and procedures in the development of eCRF design

  • Review monitoring visit reports; liaise with monitors to understand any trends on data management issues/ICF issues/study binder issues/site staff issue to develop solutions

  • Review clinical trial data - monitor data quality and ensure appropriate quality measures are in place

  • Ensure consistency of study execution across studies to facilitate data analysis and regulatory filing

  • Study specific vendor interaction and coordination

  • Liaise with clinical drug supply/manufacturing to ensure co-ordination for trial subjects

  • Maintain TMF and ensure inspection readiness

  • Proactive stakeholder management and communication of progress and issues

Qualifications and Skills

  • Minimum of a BA/BS in Life Sciences Degree

  • Previous leadership in a matrix environment

  • 7+ years of industry-sponsored clinical trial management experience required. Experience with biologics or cell and gene therapy is a plus

  • Strong knowledge of clinical operations and the regulatory process - experience independently running/managing multiple clinical trials preferably within the oncology area

  • EDC including trial management, data review, issuing and resolving queries, CRF design/review/ approval

  • Prior experience with clinical protocol development and/or regulatory submissions and management

  • Strong interpersonal and communication skills (both spoken and written) with ability to effectively communicate on project planning, progress, tracking etc

  • Strong relationship building skills to work effectively with others in various disciplines and levels

  • Strong leadership and negotiation skills with ability to employ different styles and/or strategies depending on team- members and situations

  • Proven ability to manage multiple, complex and competing priorities to effective and efficient conclusion

  • Project experience leading cross-functional teams in a matrix environment

  • Experience working cross-culturally a plus

  • Ability to operate strategically and tactically

  • Sense of urgency and ability to work effectively to timelines

  • Highly motivated, independent and a self-starter

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VIEW JOBS 11/11/2018 12:00:00 AM 2019-02-09T00:00 Director, Clinical Scientist * Philadelphia, PA * Full Time * Clinical Operations * Senior Manager/Supervisor Share Job Summary The Director level Clinical Scientist role is a global role, based in either the US or the UK. The role provides scientific input and oversight, as well as leadership and management of cross-functional execution of clinical studies, within Adaptimmune's programs. The Clinical Scientist will be responsible for global clinical trial delivery including the planning, management and reporting of trials in accordance with company plans/objectives, GCP, local country requirements and company standard operating procedures. This includes writing and/or reviewing protocols, interacting with sites for feasibility assessment, site selection, start up, study conduct, data cleaning/review, and close-out, for one or more clinical trials. Responsibilities and Duties * Support study design, translate scientific imperative into operational delivery of trials. Review and/or writing of study concept, protocol, study plans, IP management plans, CSRs * Lead the cross-functional Study Conduct Team – drive operational delivery and facilitate issue resolution * Plan timelines, conduct study feasibility, risk assessment/management and contingency planning. Ensure timelines are communicated to all personnel assigned to the study (including vendors) * Plan and/or conduct site evaluation and initiation; develop and maintain effective relationships with clinical sites globally * Provide guidance on protocol and procedures in the development of eCRF design * Review monitoring visit reports; liaise with monitors to understand any trends on data management issues/ICF issues/study binder issues/site staff issue to develop solutions * Review clinical trial data - monitor data quality and ensure appropriate quality measures are in place * Ensure consistency of study execution across studies to facilitate data analysis and regulatory filing * Study specific vendor interaction and coordination * Liaise with clinical drug supply/manufacturing to ensure co-ordination for trial subjects * Maintain TMF and ensure inspection readiness * Proactive stakeholder management and communication of progress and issues Qualifications and Skills * Minimum BA/BS in Life Sciences Degree * Experience leading cross-functional and cross-cultural teams in a matrix environment. * 10+ years of industry-sponsored clinical trial management experience required. Experience with biologics or cell and gene therapy is a plus * Strong knowledge of clinical operations and the regulatory process - experience independently running/managing multiple clinical trum preferably within the oncology area * EDC including trial management, data review, queries, CRF design/review/ approval * Prior experience with clinical protocol development and/or regulatory submissions and management * Strong interpersonal and communication skills (both spoken and written) – with ability to effectively communicate on project planning, progress, tracking etc * Strong relationship building skills to work effectively with others in various disciplines and levels * Advanced leadership and negotiation skills with ability to employ different styles and/or strategies depending on team- members and situations. * Proven ability to manage multiple, complex and competing priorities to effective and efficient conclusion * Ability to effectively operate strategically and tactically * Effective mentor to less experienced colleagues * Sense of urgency and ability to work effectively to timelines * Highly motivated, independent and a self-starter Read More Apply for Position Adaptimmune Therapeutics Plc Philadelphia PA

Associate Director, Clinical Scientist

Adaptimmune Therapeutics Plc