Sanofi Group Sr. Director, Boston Site Head CMC Dossier & Development in Westborough, Massachusetts

The CMC Dossier Development and Coordination (CDDC) department within the Sanofi R&D Operations organization has the broadly defined roles and responsibilities for the development, coordination and delivery of high-quality CMC dossiers in a timely manner for all small and large molecule based pharmaceutical and biopharmaceutical products from First in Human clinical studies to Market Authorization Applications.

As part of the global CDDC organization, the CDDC US organization consists of industrial scientists and/or CMC professionals who possess in-depth CMC product development experience and expertise. In particular in the area of Biologic products they are well versed with the CMC dossier regulatory requirements and expectations. It provides the expertise and guidance to all aspects of CMC dossiers throughout the product development cycles. In collaboration with the CMC and regulatory CMC teams, it develops dossier development strategies, execution plan and coordinates with CMC functional areas for the final delivery of high-quality CMC dossiers in full alignment with the project milestone objectives and timelines. It anticipates, proposes and develops regulatory solutions for CMC technical challenges during the product development cycles. It serves as liaison to closely align the global support with the CMC dossier needs, interfaces and ensures full alignment globally within the company and with external business alliance partners.

Job Responsibilities/Department Description:

We seek a proven leader to join and lead a dynamic CMC Dossier Development and Coordination (CDDC) group, based in Westborough, MA, USA, dedicated to the development of CMC dossiers for regulatory submissions. As the head of the CDDC US team, you will lead the CDDC US group and be responsible for all the aspects of activities involving the group, which includes, but is not limited to:

  • Lead CDDC US to support CDDC Global for its overall business and project objectives. Report to and work with the CDDC Global Head, allocate projects, budgets and resources to properly support Sanofi pharma pipeline products for CMC dossier submissions throughout the various development stages from IND/IMPD/CTA clinical applications to NDA/BLA/MAA market authorization applications.

  • Build a high performance team and lead/inspire the team members to contribute and deliver clinical and registration CMC dossier submissions. Plan and set CDDC US objectives and goals. Direct and supervise the CDDC US group members to achieve the objectives. Run the CDDC US operations effectively and align with the CDDC global and site heads for global CMC dossier submissions.

  • Interact with key stakeholders cross-functionally in iCMC NPP, Biologics Development, Quality, Regulatory and Regulatory CMC & Devices, IA Biologics & Devices, North America (NA, Boston) hub leaders to align the CDDC US activities with the CMC product development timelines and R&D NA hub objectives.

  • Have in-depth and width product development CMC experience and technical expertise, in particular, in Biologics, to understand and support the CMC dossier functions and manage pipeline products CMC dossiers for regulatory filings, agency communications and registration approvals of clinical trial applications as well as market authorizations. Specific responsibilities include: review and approve dossier documents, resolve issues for solutions during dossier preparations, interact with project teams, governance committees and senior management for timely resolution of critical issues for a timely submission of quality dossiers.

  • Ensure seamless submission of CMC Dossiers for assigned projects in development for clinical studies, registration and approval, emphasizing scientific content and quality consistent with current & evolving regulatory requirements and expectations. Liase with the CMC teams including the regulatory CMC organizations to bring/interpret agency queries to the global team and with agency on behalf of the global team to address agency questions for successful regulatory submissions and approvals. Be responsible for executing the assignments and ensuring timely delivery of quality dossiers and communication.

Qualifications:

  • An undergraduate (e.g., bachelor) or an advanced graduate degree (e.g., Ph.D.) with background in the fields of biomedical sciences such as biology, biochemistry, protein chemistry, bio-engineering.

  • A minimum of 15 years of experience for an undergraduate or 10 years for a graduate degree holder in Biologics R&D development in pharmaceutical/biotech industry and/or regulatory agencies with emphasis on CMC development or regulatory CMC. Worked in CMC development organizations or regulatory agencies with expertise in product development, registration and demonstrated accomplishments in product development and CMC filings.

  • Proven track records of accomplishments in the industry in both technical fields as demonstrated by the significant contributions to product development, publications, patents and presentations and management of people and organizations.

  • Understanding of entire R&D processes and state-of-the-art approaches in biologics, notably in the CMC development area. Expertise and experience in one or more of the following areas: bio-research, bio-development including upstream and downstream process development, analytical development and/or formulation development and/or GMP bio-manufacturing.

  • Biologics CMC dossiers fluency. CMC dossiers include, but not limited to, clinical study applications (IND/IMPD/CTA), market authorization applications (BLA/NDA/MAA) and regulatory documents for major product development milestone regulatory agency meetings, inspections and written responses to CMC related questions.

  • Ability to demonstrate proactive and influential leadership, sound judgement and decision making abilities and anticipate, prevent and resolve CMC and CMC dossier problems.

  • Have excellent people, communication and presentation skills

  • Fluent in English (mandatory).

Desired Knowledge and Skills:

  • CMC knowledge and experience in small molecule product development

  • International experience (international assignments and/or multinational projects & teams)

  • French and/or German language skills are a plus

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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