Associate Director, Preclinical Pharmacology, Fertility

The businesses of Merck KGaA, Darmstadt, Germany•Billerica, MA

2h•$126,900 - $215,400•Hybrid

About The Position

The Associate Director, Preclinical Pharmacology (reporting to the Head of Preclinical Pharmacology, Research Unit Neuroscience & Immunology) serves as the scientific and operational lead for in vivo pharmacology across the Fertility asset portfolio, with cross-disciplinary contributions to Immunology & Inflammation (I&I) and Neuroscience programs. Working within a cross functional project team, you will lead multiple, high-priority fertility programs, accountable for designing, executing, and interpreting in vitro and in vivo studies that drive candidate selection, dose regimen design, and translational strategy, ultimately contributing to IND-enabling packages and regulatory submissions. Location: Hybrid – 3x/week onsite in Billerica, MA required. Fertility Pharmacology Expertise Design, execute, and interpret pharmacology studies supporting GPCR small-molecule agonist and allosteric modulator programs across multiple species. Develop and validate reproductive endocrine models including superovulation, folliculogenesis, luteinisation, corpus luteum maintenance, and/or testicular steroidogenesis. Establish pharmacodynamic readouts (LH surge, estradiol, progesterone, inhibin B, AMH) and integrate findings with PK/PD modelling teams to define exposure-response relationships. Define and execute IND-enabling pharmacology packages; author pharmacology sections of regulatory submissions and contribute to safety pharmacology strategies. Drive mechanistic understanding of biased agonism and receptor desensitisation/downregulation in reproductive tissues to inform candidate selection. Cross-Functional Project Leadership Serve as co-project lead for the Fertility asset portfolio within cross-functional project teams (Medicinal Chemistry, DMPK, Clinical Pharmacology, Safety, etc). Author and review scientific documents including pharmacology summaries, target validation reports, and pre-IND briefings. Manage relationships with academic KOLs and reproductive biology CROs; oversee outsourced study design, execution, and data quality. Define and track in vivo pharmacology KPIs, study timelines, and quality indicators to ensure program milestones are met on schedule.

Requirements

Ph.D. in Reproductive Biology, Endocrinology, Pharmacology, Physiology, or Neuroendocrinology
8+ years of drug discovery experience, with at least 5+ years in a pharmaceutical or biotech industry setting.
Proven track record as an in vivo pharmacology workstream lead on a cross-functional drug discovery team.
Hands-on experience with rodent reproductive endocrine models (superovulation, ovarian stimulation, luteinisation, HPG axis manipulation).
Strong PK/PD modelling and biomarker development background in hormonal/endocrine contexts.
Experience with IND-enabling study design, execution, and regulatory documentation;
Demonstrated understanding of neuroendocrine-immune axis biology and its translational relevance.
Experience managing CRO partnerships and external academic collaborations.

Nice To Haves

Ph.D. in Reproductive Biology, Endocrinology, Pharmacology, Physiology, or Neuroendocrinology
10+ years of drug discovery experience, with at least 7+ years in a pharmaceutical or biotech industry setting, specifically leading fertility programs from hit discovery to developmental candidate
Postdoctoral experience in reproductive or neuroendocrine pharmacology.
Direct experince and expertise in GPCR pharmcology, specicallicay small-molecule allosteric modulators or biased agonists.
Additional expertise in endometriosis in vivo models (ectopic tissue implant, progesterone resistance assays) or placental/trophoblast invasion models relevant to pre-eclampsia.
Additional experience with pain biology experience — visceral, inflammatory, or neuropathic pain models.
Track record of cross-therapeutic area collaboration resulting in novel mechanistic insights or publications

Responsibilities

Design, execute, and interpret pharmacology studies supporting GPCR small-molecule agonist and allosteric modulator programs across multiple species.
Develop and validate reproductive endocrine models including superovulation, folliculogenesis, luteinisation, corpus luteum maintenance, and/or testicular steroidogenesis.
Establish pharmacodynamic readouts (LH surge, estradiol, progesterone, inhibin B, AMH) and integrate findings with PK/PD modelling teams to define exposure-response relationships.
Define and execute IND-enabling pharmacology packages; author pharmacology sections of regulatory submissions and contribute to safety pharmacology strategies.
Drive mechanistic understanding of biased agonism and receptor desensitisation/downregulation in reproductive tissues to inform candidate selection.
Serve as co-project lead for the Fertility asset portfolio within cross-functional project teams (Medicinal Chemistry, DMPK, Clinical Pharmacology, Safety, etc).
Author and review scientific documents including pharmacology summaries, target validation reports, and pre-IND briefings.
Manage relationships with academic KOLs and reproductive biology CROs; oversee outsourced study design, execution, and data quality.
Define and track in vivo pharmacology KPIs, study timelines, and quality indicators to ensure program milestones are met on schedule.