- Collaborate with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams
- Raise study issues to the clinical lead
- Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators
- Evaluates relevant medical literature and status from competitive products
- Review and validate the final protocol and protocol amendments
- Review the ICF WSI and TDF
- Assisted by related functions (e.g. clinical operations, project management, and procurement), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
- Lead the study specific committees (IDMC, steering com, adjudication ...) with operational support
- Co-Develop the SAP in collaboration with bio stats
- Responsible for key results preparation
- Develop the clinical study report
- Take on as necessary the Associate CRD role:
- Develop the abbreviated protocol
- Develop the final protocol and protocol amendments
- Medical support to clinical operation team during the clinical feasibility
- Review and provide clinical input across different study documents written subject information, CRF, e-diary, monitoring plan
- Medical support to clinical operations team on study plans: CMP/MRP, DR & DS review
- Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc)
- Participate in the elaboration of training material and presentations at the investigator meetings
- Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, ...) with operational support, bio stat and GSO
- Answer to medical questions raised by EC/IRBs, sites
- Support CRD trial master file documents readiness and availability, and mandatory trainings linked to the clinical function
- Collaborate and communicate appropriately with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs), including but not limited to:
- feasibility managers for feasibility preparation and validation of feasibility results
- Medical Writers to develop, review and finalize WSIs, study protocols and reports
- Clinical Scientists, Medical review team and Coding
- Pharmacovigilance (GSO, CME)
- CTOMs, Biostatisticians
- CSU medical advisors for the best knowledge of the study, compound, protocol
- TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs
- CROs
- Regulatory affairs
- Collaborates with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with 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 the global project head and clinical lead
- Provide operational expertise to project clinical sub team, as needed
- Review and/or contribute in the the clinical section of the Investigator's brochure, CTA, IND, DSUR, INDAR, DRMP, RMP
- Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIPContribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities
- Ensures clinical data meets all necessary regulatory standards
- Participates in Advisory Committee preparation
- Robust Scientific and medical/clinical expertise
- Expertise in clinical development and methodology of clinical studies
- Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
- Demonstrated capability to challenge decision and status quo with a risk-management approach
- Ability to negotiate to ensure operational resources are available for continued clinical conduct
- Fluency in written and spoken English
- Very good teaching skills, demonstrated ability to assist and train others
- Ability to work within a matrix model
- International/ intercultural working skills
- Open-minded to apply new digital solutions
- Medical Doctor (MD): trained in allergy and/or immunology and/or dermatology
- English fluent (spoken and written)
- Experience in clinical trials (industry or academia as PI)
- Computer skills
-
Clinical Research Director I&I
7 hours ago
Sanofi Group Cambridge, United States**CLINICAL RESEARCH DIRECTOR, I&I** · The Clinical Research Director (CRD), Amlitelimab, Immunology and Inflammation Therapeutic Area is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to ...
-
Clinical Research Director, I&I
7 hours ago
Sanofi Group Cambridge, United StatesThe Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical ope ...
-
Clinical Research Director, I&I
7 hours ago
Sanofi Group Cambridge, United StatesThe Clinical Research Director (CRD), Amlitelimab, Immunology and Inflammation Therapeutic Area is responsible for the development, execution and reporting of clinical trials in support of the registration of a product, directly reporting to the Clinical Lead in charge of the cli ...
-
Senior Clinical Research Director, I&I
7 hours ago
Sanofi Group Cambridge, United States**Senior Clinical Research Director, Early Development** · The Senior Clinical Research Director (Sr CRD) supports several early stage programs and manages a team of Clinical Research Directors and Clinical scientists in Early Development I&I. The Sr CRD reports into the Head of ...
-
Program Director I
4 days ago
The Home for Little Wanderers Somerville, United StatesWhen you join The Home for Little Wanderers, you join a team of professionals dedicated to creating better, brighter futures for kids. · For over 200 years, The Home for Little Wanderers has helped build stable lives and hopeful tomorrows for vulnerable children and their famili ...
-
Clinical Research Director, I&I
4 weeks ago
Sanofi Group Cambridge, United States Paid WorkThe Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical ope ...
-
Paramedic I
3 weeks ago
St Joseph Health Somerville, United States Full timeOverview · Paramedic I · Provides professional patient care and transportation in accordance with all departmental and St. Joseph Health System operating policies, city and state laws, and applicable contracts. · CHI St. Joseph Health – College Station/Bryan TX Since 1936 CHI S ...
-
Therapist I
2 weeks ago
RWJ New Brunswick Somerville, United States Full timeJob Overview: · RWJBarnabas Health is looking to add a qualified full-time Therapist I in Somerville, NJ · Qualifications: · Required: · Masters degree from an accredited school of Social Work or Counseling degree from an accredited school, PhD from an accredited college or unive ...
-
Medical director i
2 weeks ago
Randstad Cambridge, United Statesjob summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large netwo ...
-
Cook I
2 weeks ago
HEI Hotels & Resorts Boston, United States Regular Full timeOverview · Prepare food of consistent quality and assist in kitchen functions. · Responsibilities · Prepare food of consistent quality following recipe cards and production and portion standards, per check from servers. · Start food items that are prepared ahead of time, maki ...
-
Plumber I
2 days ago
City of Cambridge Cambridge, United StatesESSENTIAL DUTIES AND RESPONSIBILITIES: · Find out more about this role by reading the information below, then apply to be considered. · Under general supervision: · Installs, removes, and maintains plumbing systems including piping fixtures, fixed appliances, ventilation systems, ...
-
Accounting Coordinator I
3 weeks ago
RELX Cambridge, United States Full timeAbout the Role · Are you a detail-oriented individual with a passion for numbers and a desire to kickstart your career in accounting? We invite you to apply for our Entry-Level Accounting Clerk position · The Accounting Coordinator will report directly to the Manager of Audit and ...
-
custodian i
1 week ago
Prince William County Schools Haymarket, United StatesJOB STATUS:OPENEFFECTIVE:2024-25POSTING DATE:06/05/2024CLOSING DATE:06/13/2024 04:30 PMPOSTING NUMBER: SCHOOL/DEPARTMENT:Battlefield HSLOCATION:Haymarket,VAPOSITION TITLE:CUSTODIAN I - NIGHT (10 MONTHS)/DAY (2 MONTHS)ADDITIONALINFORMATION/REQUIREMENTS:An essential function of thi ...
-
Research Technician I
1 week ago
Howard Hughes Medical Institute Cambridge, United States Full timeHHMI is focused on supporting and moving science forward in a variety of different ways ranging from conducting basic biomedical research, empowering educators, inspiring students, developing the next generation of scientists – even stretching into film and media production. Our ...
-
Applications Analyst I
1 week ago
Mass General Brigham Somerville, United States RegularApplications Analyst I - Digital Patient Experience Platforms Description General Summary/ Overview: · At Mass General Brigham Digital, we pride ourselves on our ability to create maximum strategic, clinical, and operational value from established and emergent technologies for ...
-
C&I Electrician
1 week ago
ARCH SOLAR C&I INC Plymouth, United StatesJob Description · Job DescriptionArch Solar C&I, Inc is now accepting applications for Electricians. We are a leader in the Solar industry, and we also provide electrical services to Commercial Customers. · The role of the Electrician is to ensure that the Electrical & Solar team ...
-
Financial Associate I
2 weeks ago
Harvard University Cambridge, United States Full timeSpecific job responsibilities include: · Respond to customer inquiries relating to B2P systems functions navigation and full life cycle of business processes, invoices, payments, holds, kick-outs), PCard, Corporate Card, and reimbursement. · Review, process, and approve day-to-d ...
-
Cook I
3 weeks ago
Embassy Boston Logan East Boston, United StatesJob Summary: · Informacin disponible en espaol a continuacin. · A Cook is responsible for preparing all food items based on standardized recipes for the Restaurant/Dining Outlet Cafe Room Service Employee Cafeteria and Banquets while maintaining the highest standards to produce ...
-
Cytogenetic Technologist I
3 days ago
Brigham and Women's Hospital Boston, United States Full timeCytogenetic Technologist I Description Cytogenetic Technologist I · Day Shift · Full Time · G ENERAL SUMMARY/ OVERVIEW STATEMENT : · The BWH Clinical Cytogenetics Laboratory serves all of the Partners HealthCare institutions and affiliates (including MGH and DFCI) and handl ...
-
Lifeguard I
1 day ago
YMCA of Greater Boston East Boston, United StatesJob Description · Job DescriptionDescription12 Hours Per Week - Morning Shift · Under the supervision of the Aquatics Director, this position is responsible for guarding the pool, ensuring the safety of all patrons, enforcing pool rules, and implementing the branch emergency pro ...
Clinical Research Director, I&I - Cambridge, United States - Sanofi Group
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
Clinical Research Director - allergy-immunology-dermatology
The Clinical Research Director (CRD) is noted as the
primary clinical expert for programs .
The role requires a well-organized, strategic and operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.
Key responsibilities include:
Participate/support clinical program lead in the clinical development plan strategies:
Lead, Support and oversee the execution of clinical development and studies activities
Responsibilities related to regulatory and safety documents and meetings:
Scientific Data evaluation and authorship: Participate and author manuscripts and abstracts Support the planning of advisory board meetings Establish and maintains appropriate collaborations with knowledge experts Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams
Experience
Minimum Level of any
Required Qualifications:
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.
\#GD-SA\#LI-SA
Pursue
_progress_
, discover
_extraordinary_
Better is out there. Better medications, better outcomes, better science.
But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.