Pheon Therapeu,cs | Director / Sr. Director, Analy,cal Development – ADCs
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The Director of Analytical Development will lead and build analytical strategies to support the
development, characterization, and lifecycle management of ADCs in the Pheon pipeline. The role
requires deep technical expertise with a strong emphasis on analytical development of monoclonal
antibodies, linker-payloads, and Antibody-Drug Conjugates (ADCs). This role is responsible for establishing
robust analytical platforms, ensuring regulatory-ready data packages, and partnering cross-functionally to
advance programs from early development through commercialization. The successful candidate will
provide scientific leadership, manage internal and external (CDMO) resources, and serve as a key
technical authority for CMC-related analytical activities.
Responsibilities
- ✓ Strategic & Scien,fic Leadership
o Develop and execute analy,cal development strategies to support ADC programs across
all stages (IND-enabling through BLA).
o Serve as a subject-maVer expert in ADC characteriza,on and stability for phase-
appropriate development of the pipeline.
o Define control strategies and analy,cal comparability approaches for process changes and
lifecycle management.
- ✓ ADC Exper,se
o Lead analy,cal method development and qualifica,on for
§ Monoclonal an,bodies
§ ADC conjuga,on metrics (DAR, drug distribu,on, free drug)
§
Linker stability and payload characteriza,on
o Oversee advanced analy,cal techniques such as
LC-MS / HRMS (intact, subunit, pep,de mapping)
§
§ SEC-MALS, CE-SDS, icIEF, HIC
§ Bioassays (binding, cell-based potency)
o Ensure fit-for-purpose methods aligned with regulatory expecta,ons for ADCs.
- ✓ Regulatory & CMC Support
o Provide analy,cal input to IND, CTA, BLA, and MAA submissions.
o Author, review, and approve analy,cal sec,ons of regulatory filings.
o Support regulatory interac,ons and health authority ques,ons related to analy,cal
development.
- ✓ Team & Resource Management
o Manage external CRO/CDMO analy,cal partnerships and vendor rela,onships.
o Establish external laboratory workflows, and best prac,ces as needed.
- ✓ Cross-Func,onal Collabora,on
o Partner closely within CMC, Quality, Regulatory Affairs, Pre-Clinical, and Clinical teams.
o Support tech transfer of analy,cal methods to Quality Control and manufacturing sites.
o Drive risk-based decision making and problem solving across programs.
Required Qualifica,ons
- ✓ Educa,on
o PhD in Analy,cal Chemistry, Biochemistry, Biophysics, Pharmaceu,cal Sciences, or related
field. (MS with significant industry experience may be considered)
o Experience
o 10+ years of industry experience in analy,cal development for biologics
o Direct, hands-on experience with ADCs (required)
o Experience suppor,ng programs through IND and into clinical development (Phase-3
development and commercial experience a plus)
- ✓ Technical Exper,se
o Deep understanding of
§ Biologics and ADC analy,cal characteriza,on
§ Method development, qualifica,on, and valida,on
§ Stability studies and comparability assessments
§ Strong knowledge of ICH guidelines (Q2, Q5, Q6) and regulatory expecta,ons for
biologics/ADCs
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Leadership & Communica,on
o Proven ability to lead mul,disciplinary teams and external partners
o Strong wriVen and verbal communica,on skills
o Comfortable presen,ng to senior leadership and interac,ng with regulatory agencies
Preferred Qualifica,ons
- ✓ Experience suppor,ng late-stage or commercial ADC programs
- ✓ Prior experience in a startup or fast-paced biotech environment
- ✓ Familiarity with novel linker-payload technologies