Director, Clinical Operations

POSITION SUMMARY

Sanofi is advancing a novel compound into the clinic and is seeking an experienced Director of Clinical Operations who will be primarily responsible for all functional activities related to execution of clinical trials.

ESSENTIAL FUNCTIONS

Clinical trial execution and oversight

• Oversee tactical implementation of the clinical development plan by managing the timeline, resources, and budget of clinical studies

• Contribute to execution strategy of clinical programs and work collaboratively with the clinical operations group and cross functional team to ensure successful implementation of clinical trials

• Drive selection of CRO and vendors through RPP and bidding process.

• Liaise with Contract Research Organizations and third-party vendors to ensure study execution and deliverables are being met

• Perform oversight activities of the CRO and ancillary vendors.

• Serve as Clinical Operations subject matter expert on clinical program(s) and cross functional initiatives such as data review, protocol deviation review, process improvements, etc.

• Provide input to clinical sections of regulatory documents including protocols, Investigator Brochures, DSURs, IND annual reports, and others as needed

• Develop study plans with the CRO and ancillary vendors to ensure study requirements and adherence to plans are achieved

• Interact and establish relationships with clinical trial investigators and ensure compliance with good clinical practices (GCP), standard operating procedures and regulatory guidelines 

• Oversee contract and budget negotiations with clinical sites

• Prepare study feasibility, enrollment and cost estimates for the clinical program(s)

Build trial operational infrastructure

• Partner with VP of Clinical Operations to develop staff, structure department, and create a highly desired work environment for attracting and retaining highly qualified clinical operations professionals

• Build, manage and nurture clinical operations staff and direct reports

• Develop and ensure compliance with company SOPs and guidelines, FDA regulations and current ICH GCP guidelines

• Evaluate and analyze tools and processes to support outsourcing efforts

• Work with Clinical Operations team to identify and develop efficient systems for enhancing department efficiency

Interface effectively with other groups within the organization

• Maintain a high level of professional expertise through familiarity with industry trends, new regulations and clinical literature 

• Work with senior management to develop and to achieve corporate goals and work with clinical operations staff to achieve the established corporate goals within the expected time frames

• Participate on project teams and study teams as needed

• Act as key resource to provide financial information related to clinical development.  Interface with finance group to manage trials costs

QUALIFICATIONS

• BA/BS degree or higher, preferably in the life sciences

• Minimum of 7 years prior clinical trial management experience, and minimum of 10 years in the pharmaceutical/biotech industry or relevant clinical research organization 

• Previous oncology clinical trial experience in early phase development is strongly preferred

• Excellent working knowledge of FDA & ICH/GCP regulations and guidelines and experience building clinical operations groups and associated infrastructure

• Demonstrated project management/clinical operations experience and leadership skills (e.g., managing cross functional study teams, CROs, vendors)

• Strong communication skills (verbal and written); effective in interaction with senior management

• Excellent judgment and problem-solving skills

• “Hands-on” ability to think strategically and tactically

• Entrepreneurial spirit with “can do” attitude, commitment to teamwork, and initiative

• Knowledge and experience with managing contracts (vendor and site) and interface with finance group

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.

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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.