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Summit Therapeutics

Associate Director, Analytical Development & CMC Statistics

Summit Therapeutics · Princeton, NJ

Posted 22 days ago

or apply directly on Summit Therapeutics's site. We never take the application ourselves.

Is this posting real?

This role has been open
22 days
Summit Therapeutics's roles stay open a median of 28 days
Reposted
No
Salary listed
No
0% of Summit Therapeutics's roles list one
Ghost-job risk at Summit Therapeutics
moderate
18 stale, 3 reposted of 80 open
Hiring momentum
111 roles opened in the last 90 days
↑ up vs. the prior 90 days
Last confirmed on the employer's board
2026-09-17

Measured from postings appearing on and disappearing from Summit Therapeutics's own greenhouse board since 2026-08-03. Full hiring picture for Summit Therapeutics.

About this role

The Associate Director of Analytical Development and CMC Statistics will lead technical and statistical efforts in analytical development for biologic drug substance and product programs. This role involves collaborating with various departments to ensure compliance and robustness of analytical strategies and data for regulatory submissions. Responsibilities include method validation, statistical analysis, and oversight of external partners, along with clear communication of findings to stakeholders.

Our read on this posting2.8out of 5
benefits
1/5
freshness
4/5
career value
4/5
role clarity
5/5
pay transparency
0/5

Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Summit Therapeutics as an employer.

What you need

  • Advanced degree(s) in Statistics, Biostatistics, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline; Bachelor's or master's degree with substantial relevant experience will be considered
  • Minimum of 10+ years of relevant experience in the biopharmaceutical or pharmaceutical industry
  • Strong knowledge and understanding of biologics analytical methods
  • Demonstrated experience with analytical method development, validation, method transfer, comparability, specification setting, stability analysis, and statistical analysis & interpretation of CMC datasets
  • Working knowledge of ICH, FDA and EMA guidance and GMP regulation
  • Experience reviewing or authoring protocols, reports, regulatory submission sections, health authority responses, deviations, OOS/OOT investigations, CAPAs, and change controls

What you get

  • Pay range of $180,000 — $200,000 USD
  • Total compensation may include bonus, stock, benefits and/or other applicable variable compensation

Worth weighing

  • Travel may be required periodically for oversight and meetings
  • No specific mention of remote work options
  • Role requires significant experience and expertise in a specialized field
  • Focus on compliance and regulatory aspects may limit creative input in analytical strategies

Summarised from Summit Therapeutics's posting. Read the full original.

Listed by Summit Therapeutics on their greenhouse job board, last confirmed open on 2026-09-17. PitchMeAI is not the employer.

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