Offers “Sanofi”

Expires soon Sanofi

Clinical Development Lead, Early - Multiple Myeloma

  • Cambridge (Middlesex)
  • IT development

Job description

JOB SUMMARY

Reporting to the Project Head for Multiple Myeloma or his designee, lead one or more multifunctional development Global Clinical Teams for early clinical development of novel compound(s), including Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan in multiple myeloma and potentially other hematologic malignancies.

JOB DESCRIPTION

· 
Establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies.

· 
Leads, supports and oversees the execution of clinical development and studies activities, including but not limiting to:

· 
Authors abbreviated protocol.

· 
Reviews the final protocol and protocol amendments.

· 
Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form.

· 
Reviews the study specific committee charters. Leads study specific committees with operational support.

· 
Leads medical data review,  clinical interpretation of study results, contributes to clinical study reports and clinical summaries.

· 
Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine

· 
Participates and contributes to regulatory and safety documents and discussions

· 
Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans

· 
Contributes to the clinical sections of INDs and CTAs, and briefing packages for regulatory meetings

· 
Scientific data evaluation and authorship

· 
Authors clinical abstracts, presentations for conferences, and manuscripts, when appropriate

· 
Supports the planning of advisory board meeting. Presents and discusses development strategy and clinical study result with external investigators and advisory boards, as appropriate

JOB REQUIREMENTS

· 
MD degree or equivalent

· 
Oncology and/or Hematology  fellowship or significant experience (5+ years) in Oncology and/or Hematology, preferably with experience in myeloma or hematologic malignancies

· 
Expertise in pharmaceutical medicine based on industry experience (3+ years) or academic clinical research experience (3+ years), preferably with experience in clinical development

· 
Demonstrated ability to interact productively with and attract top external investigators

· 
Demonstrated ability to work with a multifunctional team to achieve project milestones

· 
Understanding of and willingness to meet applicable regulatory, quality and compliance standards

· 
Position will be based in Vitry, France or Cambridge, MA, USA.

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society. 

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

JOB SUMMARY

Reporting to the Project Head for Multiple Myeloma or his designee, lead one or more multifunctional development Global Clinical Teams for early clinical development of novel compound(s), including Clinical Operations, Biostatistics, Regulatory, Translational Medicine, Project Management, New Product Planning and Pharmacovigilance to establish the development strategy and execute the development plan in multiple myeloma and potentially other hematologic malignancies.

JOB DESCRIPTION

· 
Establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies.

· 
Leads, supports and oversees the execution of clinical development and studies activities, including but not limiting to:

· 
Authors abbreviated protocol.

· 
Reviews the final protocol and protocol amendments.

· 
Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form.

· 
Reviews the study specific committee charters. Leads study specific committees with operational support.

· 
Leads medical data review,  clinical interpretation of study results, contributes to clinical study reports and clinical summaries.

· 
Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine

· 
Participates and contributes to regulatory and safety documents and discussions

· 
Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans

· 
Contributes to the clinical sections of INDs and CTAs, and briefing packages for regulatory meetings

· 
Scientific data evaluation and authorship

· 
Authors clinical abstracts, presentations for conferences, and manuscripts, when appropriate

· 
Supports the planning of advisory board meeting. Presents and discusses development strategy and clinical study result with external investigators and advisory boards, as appropriate

JOB REQUIREMENTS

· 
MD degree or equivalent

· 
Oncology and/or Hematology  fellowship or significant experience (5+ years) in Oncology and/or Hematology, preferably with experience in myeloma or hematologic malignancies

· 
Expertise in pharmaceutical medicine based on industry experience (3+ years) or academic clinical research experience (3+ years), preferably with experience in clinical development

· 
Demonstrated ability to interact productively with and attract top external investigators

· 
Demonstrated ability to work with a multifunctional team to achieve project milestones

· 
Understanding of and willingness to meet applicable regulatory, quality and compliance standards

· 
Position will be based in Vitry, France or Cambridge, MA, USA.

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society. 

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.  

#GD-SA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Make every future a success.
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