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SR Clinical Study Director, Bridgewater, NJ
BRIDGEWATER NJ 08807
Category: Health Care Industry
  • Your pay will be discussed at your interview

Job code: lhw-e0-90664707

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Sanofi Group

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Summary

  Job posted:   Thu Jun 7, 2018
  Distance to work:   ? miles
       
  1 Views, 0 Applications  
 
SR Clinical Study Director, Bridgewater, NJ
+ The role of the Senior CSD is to provide medical expertise for:1. The clinical studies (except Clinical & Exploratory Pharmacology studies) and/or registries to be carried out by Clinical Sciences & Operations (eg: protocol, Key Results Memo, Clinical Study Report).2. Other clinical development activities (e.g. pre-assessment and cluster feasibility, medical reviewand validation of clinical data, study risk assessment).3. Contribute to the clinical part of Common Technical Document for FDA & EMA submission, answers to questions from health authorities for submission dossier).


+ The Sr CSD will provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators.

+ The Sr CSD will be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data.

+ He/she will have to interact with Strategic Units/Divisions/Franchise, Regulatory, Pharmacovigilance (CME, GSO), Project Leaders from CSO, feasibility managers, CTOMs, biostatisticians, Clinical Documentation (Medical Writers), Monitoring team, Coding team, and for the studies from the Medical Affairs (global or regional) with Medico-marketing representatives from the appropriate departments.


+ The Sr CSD acts as a Dedicated Project Expert (DPE) in OMD&CD on programs requiring this type of role. In addition, the Sr CSD acts as a mentor for other CSDs and CS on a same project/TA.


MAJOR DUTIES & RESPONSIBILITIES:


1. Provide expertise and act as a reference for all medical operational activities related to the projects/studies he/she is assigned to.


2. Write/contribute/review/QC/validate study related documents: clinical protocols, written subject information, trial disclosure form, Case report form, study plans (eg: study risk management plan, central monitoring plan), study reports, material for training and meetings (such as investigators Meetings). Contribute to publications and communications of results. Potentially write ES in some specific cases (eg: Medical Affairs studies).


3. Collaborate and communicate appropriately with all stakeholders for optimal study execution, including but not limited to: ? feasibility managers for feasibility preparation and validation of feasibility results ? Clinical Scientists, Medical review team and Coding ? Pharmacovigilance (GSO, CME) as regard to safety management and case processing ? CTOMs, Biostatisticians ? CSU medical advisors for the best knowledge of the study, compound, protocol ? Units/Divisions and medical affairs ? CROs ? Regulatory affairs


4. Challenge appropriately the study extended synopsis based on feasibility pre-assessment, protocol complexity index and associated cost.


5. Provide strategic & operational expertise to unit/department clinical sub team, as needed.


6. Responsible and accountable for overall supervision/execution of medical validation/review of study data, including writing or supervision of study related documents (eg: medical review plan, guidelines, etc...).


7. Is key role to organize/contribute to Investigators' Meetings, Steering Committees, Data Monitoring Committees Meetings, adjudication committees and prepare related material (eg charter, presentations).


8. Provide medical answers to questions from Health Authorities, IRB/Ethics Committees, Investigators, experts, clinical study team.


9. Secure CSD trial master file documents readiness and availability, and mandatory trainings linked to the function.


10. Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc). 11.Key role with Medical Writer to develop, review and finalize study protocols and reports.


12.Maintain medical expertise in the therapeutic domain.


13. As a DPE, he/she is the key medical reference for the compound in OMD&CD, ensures uniform, aligned operational approach (eg harmonizing study documents, ES, protocols, etc), as relevant, within a project, ensures leadership, builds consensus, coordinates action plans with other CSDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to CSO and Division/Unit partners, as relevant and shares relevant information within OMD&CD (eg CSDs, Clinical Scientists) and beyond (project teams, etc.).


14. The DPE-CSD has a mentoring and/or supervising role of more junior CSDs and Clinical Scientists supporting the studies within the same project or in the same therapeutic area/indication that he/she is in charge of, and in particular the strategic aspects of the IDP, relevant pre-clinical, compound, scientific, medical/indication-specific issues, specific safetyrelated issues (e.g. drug-class, compound, DDI, study population), the medico-marketing environment, the strategic medico-marketing plan, and key regulatory challenges.


15. The Sr CSD (or DPE) participates in transversal taskforces, working groups, best practice initiatives and project or therapeutic area meetings, as required.


16. Uniform dissemination of relevant project-related information coming from the unit/department clinical sub team to the CSDs, clinical scientists and other relevant CSObased study team members that conduct the project-related phase 2/3/4 clinical research studies for unit/department based clinical development programs.


Knowledge And Skills:


-Strong Scientific and medical expertise


- Strong expertise in clinical development and methodology of clinical studies


- Demonstrated strong leadership, foster team motivation, ability to influence and drive decisions


- Quality focused and well organized - Strong communication skills (verbal and written) - Ability to handle multiple tasks and to prioritize


- Ability to synthesize the information, good presentation skills


- Strong decision maker - Demonstrated capability to challenge decision and status quo with a risk-management approach


- Ability to negotiate - Ability to work autonomously and to efficiently & effectively provide status reports


- Demonstrated ability to develop an holistic approach as regard to study and program conduct, identify synergies, coordinate a group of CSDs and organize delegation


- Ability to anticipate and timely escalate issues and to define appropriate action plans


- Team and results oriented


- Teaching skills, demonstrated ability to assist and train others - Ability to work within a matrix model.


Formal Education And Experience Required:


-Licensed Medical Doctor: GP or specialist, English fluent (spoken and written)


Prior experience: - at least 5 years in pharmaceutical industry or CRO, previous experience in clinical development (phase 2/3)


Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.


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Sanofi achieves its mission, in part, by offering rewarding career opportunities which inspire employee growth and development. Our 6 Recruitment Principles clarify our commitment to you and your role in driving your career.


Our people are responsible for managing their career

Sanofi posts all non-executive opportunities for our people

We give priority to internal candidates

Managers provide constructive feedback to all internal interviewed candidates

We embrace diversity to hire best talent

We expect managers to encourage career moves across the whole organization


A few practical tips:

Be sure to regularly update your Workday profile to simplify the application process

Be aware of any applicable eligibility criteria in the country to which you are applying

Before applying, inform your manager so they may support your career development goals


Sanofi careers - it all starts with you!


Sanofi achieves its mission, in part, by offering rewarding career opportunities which inspire employee growth and development. Our 6 Recruitment Principles clarify our commitment to you and your role in driving your career.


Our people are responsible for managing their career

Sanofi posts all non-executive opportunities for our people

We give priority to internal candidates

Managers provide constructive feedback to all internal interviewed candidates

We embrace diversity to hire best talent

We expect managers to encourage career moves across the whole organization


A few practical tips:

Be sure to regularly update your Workday profile to simplify the application process

Be aware of any applicable eligibility criteria in the country to which you are applying

Before applying, inform your manager so they may support your career development goals


Sanofi careers - it all starts with you!

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