Job Title: CMC Demand & Supply Leader
Location: Framingham, MA
About the Job Within CMC function, in the Global CMC Project Management department, the ambition is to expand a strong End to End R&D Supply Demand integrating Demand Forecast & Planning of Supplies, supporting Projects Development and Operations through the entire value chain (from R&D to LCM). With the aim of developing a Demand & Supply Center of Excellence, the mission of the Demand & Supply Leader is to integrate Project Strategy, Clinical and CMC Operational plans for an early definition and optimization of E2E Demand & Supply plan while considering cost & risk to support execution of Projects in respect to Regulatory and Quality requirements.
This role offers the opportunity to join a dynamic and skilled team at a pivotal time as we strengthen our in-house expertise, accelerate digital transformation initiatives, and build sustainable internal capabilities to support an increasing portfolio of innovative projects across multiple therapeutic areas.
Main Responsibilities- Lead collaborative work with Global project Management, Clinical Development and CMC to define clinical assumptions and CMC hypothesis to forecast Clinical Demand.
- Forecast Long Range Plan Demand based on assumptions worked with interfaces.
- Consolidate non-clinical & clinical demand and propagate to M&S Global Supply Chain.
- Integrate all Development Demand and align with operational plans (CMC, CSO, TMED, DMPK, PCS) and Regulator submission/approval plans.
- Run forecast & alignment scenario with associated risks and costs to support strategic project decisions and budget definition.
- Co-lead Demand & Supply Sub Team and ensure End to End supply optimization with the contribution of key stakeholders.
- Accountable for defining the best sourcing and supply strategy for marketed products/comparators, including forecast and budget.
- Lead the definition of drug products blinding strategy to ensure clinical trial products indistinguishability.
- Ensure DS/DP batches allocation to IMP batches and on time products delivery to packaging sites and oversee associated Material Flow & Documentation management.
- Provide reporting/KPIs to monitor & improve Supply performance
- Contribute to project documents & meetings preparation by providing standard Demand & Supply Reports (e.g. IDCC/DWG/ORC, IDP, Operational plan, Supply agreement).
- Can support transversal initiatives contributing to simplification & harmonization.
About YouBasic Qualifications
Education- PhD in Sciences (Neurosciences, Microbiology, Immuno-inflammation, Gene Therapy, Rare Diseases, Pharmaceutical Sciences, Biochemistry, Molecular Biology, Biotechnology, Biomedical Sciences, Genetics), Pharmacist, or Engineer in Health Sciences, Chemical Engineering, or Biomedical Engineering
- OR Master of Science (MS) degree in any of the above fields
- OR Bachelor of Science (BS) degree in any of the above fields
- Related scientific or life sciences disciplines will be considered
Experience- PhD holders: Minimum 3 years in Research and Development or Clinical Development.
- Master's holders: Minimum 5 years in Research and Development or Clinical Development.
- Bachelor's holders: Minimum 8 years in Research and Development or Clinical Development.
- Minimum 2 years in Demand Management in Research and Development in the domain of Oncology, Immuno-inflammation, Rare Disease, Neurology, or Multiple Sclerosis (included within total years of experience, not additional)
- CMC experience.
- Ability to navigate complex and regulated environments (GMP and GCP regulations)
- Knowledge of data analytics and forecasting
- Project Management experience
Preferred Qualifications
- Experience in the development of diverse modalities (Mammalian, Genomic, Microbial, Synthetics)
- Excellent knowledge of Projects Development, Clinical & Preclinical Development, Clinical Supply Chain, CMC, R&D and M&S interfaces
- PMI certification
- Experience in Power BI/Power App and project management software
- Experience in management of co-development projects, companies' integration and contracts management
- Knowledge of Industrial Supply Chain principles
- Strong interpersonal/networking skills, team-work and transversal collaboration
- Ability to understand complex processes quickly and act as referent for the department
- Strong ability to work under pressure and address complex situations
- Team management experience is a plus
Why Choose Us- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Help improve the lives of millions of people globally by making drug development quicker and more effective.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
The salary range for this position is:
$122.250,00 - $176.583,33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
