Director, Translational Bioanalytical Sciences

Scorpion Therapeutics; Bridgewater (MA); On-site; USD 250,000 - 420,000; Full time

Benefits offered by this job

Medical, dental, vision

Mental health support

Wellbeing reimbursement

401(k) with match

Annual equity awards; ESPP

Company-paid life/disability

Learning/mentorship programs

Job summary

Scorpion Therapeutics seeks a Director of Translational Bioanalytical Sciences to lead development, validation, and strategic application of bioanalytical assays across small molecules, biologics, and evolving modalities.

You will partner with cross-functional teams to shape translational strategies, oversee CROs, support regulatory interactions, and mentor teams while driving adoption of new technologies in a fast-paced clinical development program.

Qualifications

• PhD in Analytical Chemistry, PK, Pharmacology, Pharmaceutics, Bioanalytical Sciences, or related field.
• 10+ years in translational sciences, bioanalysis, biomarkers, and clinical development.
• Experience building/mentoring scientific teams.
• Expertise in LC-MS/MS across modalities.
• Regulated and non-regulated bioanalytical study design/management.
• Strong lifecycle management knowledge and regulatory guidance.
• Experience managing CRO/partner governance and outsourcing.
• Broad understanding of drug development and translation to strategy.
• Track record on global cross-functional project teams.
• Regulatory knowledge including health authority interactions (IND/CTA/NDA/BLA).

Responsibilities

• Provide scientific leadership for development/validation of bioanalytical and biomarker assays.
• Partner with cross-functional teams on Translational Bioanalytical strategies.
• Represent TBAS on global project teams for strategy and regulatory interactions.
• Lead assay development and validation with CROs/partners ensuring compliance.
• Plan and oversee regulated/non-regulated bioanalytical testing for studies.
• Support clinical study design with input into protocols and biomarker plans.
• Author/review submissions (INDs, CTAs, NDAs, etc.).
• Interpret data to inform dose selection and patient stratification.
• Establish vendor governance and oversee CROs for quality and timelines.
• Mentor and drive adoption of emerging technologies.

Skills

Scientific leadership

Cross-functional collaboration

Regulatory knowledge

Team mentoring

CRO governance

Education

PhD in Analytical Chemistry or related field

Tools

LC-MS/MS

Bioanalytical methods

Pharmacokinetics

Job description

About The Role

Director, Translational Bioanalytical Sciences (Clinical Development, Translation Bioanalytical Science). Lead development, validation, and strategic application of bioanalytical and biomarker assays supporting small molecules, biologics, and emerging mixed-modality therapeutics from early development through clinical evaluation.

What You'll Do

• Provide scientific leadership and strategic oversight for development/qualification/validation/implementation of bioanalytical, biomarker, pharmacodynamic, immunogenicity, and translational assays across modalities.
• Partner with cross-functional teams to develop and execute integrated Translational Bioanalytical and Biomarker strategies.
• Serve as TBAS representative on global project teams for strategy, decisions, and regulatory interactions.
• Lead assay development and validation (including via CROs/partners) ensuring compliance with FDA/EMA/ICH/CLSI (e.g., ICH M10).
• Plan and oversee regulated/non-regulated bioanalytical testing supporting preclinical and clinical studies.
• Support clinical study design with input into protocols, SAPs, lab manuals, biomarker plans, and sample management.
• Author/review scientific input to INDs, CTAs, NDAs, BLAs, PMAs, Investigator’s Brochures, Briefing Books, Clinical Study Reports, and other submissions.
• Interpret and integrate data to inform dose selection, proof-of-mechanism/bio(ology), patient stratification, and key decisions.
• Establish vendor governance; oversee external CROs/contract labs for quality, compliance, budget, and timelines.
• Mentor and provide technical leadership; drive adoption of emerging technologies.

Who You Are (Qualifications)

• PhD in Analytical Chemistry, PK, Pharmacology, Pharmaceutics, Bioanalytical Sciences, or related field.
• 10+ years progressive biopharma/pharma experience in translational sciences, bioanalysis, biomarkers, and clinical development.
• Leadership experience building/mentoring scientific teams.
• Expertise in advanced bioanalytical technologies, especially LC-MS/MS, across modalities.
• Experience in regulated and non-regulated bioanalytical study design/management/interpretation.
• Strong knowledge of method development/qualification/validation/lifecycle management and regulatory guidance.
• Experience managing CRO/partner governance and outsourcing.
• Broad understanding of drug development and translating science to development/registration strategy.
• Track record across global cross-functional project teams.
• Deep regulatory knowledge (bioanalytical, biomarkers, immunogenicity) including health authority interactions and filings (IND/CTA/NDA/BLA/global submissions).

Benefits (U.S. offerings)

• Medical, dental, vision, mental health support, wellbeing reimbursement, EAP.
• Paid time off; fertility/family-forming, caregiver support; flexible schedules with purposeful in-person collaboration.
• 401(k) with match; annual equity awards; ESPP; company-paid life/disability.
• Learning/mentorship via Company Learning Institute; resource groups and recognition.