Executive Medical Director, Clinical Development, Hematology, Nephrology, & Transplant, Cell Therapy

Executive Medical Director (EMD), Clinical Development, Nephrology

Location: Boston, MA

Role overview

• Oversees 2+ clinical programs from IND through Phase 3 (FIH, PoC, registrational) under the VP/TA Head.

• Provides medical leadership and mentorship to Medical Directors and Clinical Development Scientists; may serve as medical monitor.

• Shapes therapeutic area, clinical, and regulatory strategy; represents Clinical Development in global governance (GPT/GMT) and supports business development due diligence.

• Partners closely with Discovery/Research; engages internal and external stakeholders to advance rare disease assets.

Therapy Area Focus: Nephrology

• Leads programs in rare and immune‑mediated kidney diseases (e.g., aHUS, C3G, IgA nephropathy, membranous nephropathy, lupus nephritis, BK viremia in transplant, thrombotic microangiopathies).

• Acts as internal expert in renal pathophysiology, complement/innate immunity, glomerular vs. tubulointerstitial disease, and biomarkers (e.g., eGFR slope, UPCR/proteinuria, albuminuria, hematuria, sC5b‑9, complement split products, NGAL/KIM‑1).

• Guides endpoint strategy (e.g., eGFR slope; ≥30–40% eGFR decline; proteinuria reduction; dialysis/transplant; histologic activity/chronicity; PROs) aligned with regional regulatory expectations.

• Collaborates with Translational Medicine on renal PD markers/biopsy substudies; with Clinical Pharmacology on dosing in CKD/dialysis; and with Biostatistics on eGFR intercurrent events, missing data, and slope estimation.

• Engages ASN/ERA and nephrology KOLs; aligns with CKD/ESRD practice trends and payer evidence needs.

Key responsibilities

• Lead clinical strategy, trial design, and endpoint selection; ensure rigorous benefit–risk assessment.

• Direct cross‑functional collaboration (Safety, Clinical Ops, Biostats, Epidemiology, Medical Affairs, Data Management, Clin Pharm, Commercial, Regulatory, Project Management); serve as medical expert for study teams and supervise medical monitors as needed.

• Oversee safety characterization and risk management, including infection risks with immunomodulation/complement inhibition, cytopenias, bleeding/thrombosis, AKI monitoring, hyperkalemia/volume status, dialysis considerations; implement vaccination/prophylaxis and dose adjustments; REMS where applicable.

• Design and execute nephrology protocols integrating standard‑of‑care therapies (e.g., RAS blockade, SGLT2 inhibitors, sparsentan, steroids), controlling for background therapy; incorporate biopsy or imaging assessments when appropriate.

• Represent Clinical Development at governance/review committees; lead clinical sections of regulatory/scientific documents (protocols, charters, CSRs, CTD clinical sections, white papers, regulatory responses, publications) and labeling inputs.

• Drive external engagement (KOLs, patient advocacy, advisory boards, ASN/ERA); optimize feasibility, biopsy logistics, sample handling, and central lab strategies for proteinuria/complement assays.

• Monitor scientific, competitive, and regulatory landscapes; synthesize insights into CDPs, asset plans, and TA strategy.

• Interpret renal biomarkers and lab trajectories (e.g., acute dips vs. chronic slope); adjudicate endpoints; inform dose selection, subgroup analyses, go/no‑go, and regulatory narratives.

• Support business development (due diligence, research collaborations) and selection of advisory board experts.

Qualifications

• Required: MD (or equivalent); 7+ years in clinical development with global regulatory/product development exposure; proven record designing and executing multinational trials; experience preparing for and attending FDA/other agency meetings; demonstrated leadership of cross‑functional teams; BD support experience.

• Strongly preferred (Nephrology): Board certification or substantial clinical training in Nephrology; expertise in rare renal or complement‑mediated diseases; prior authorship of nephrology protocols and regulatory documents; experience with ASN/ERA forums and nephrology regulatory interactions; familiarity with nephrology endpoints, eGFR methodologies, proteinuria analytics, and dosing/PK in CKD/dialysis.

• Desirable: PhD or advanced training; advanced therapy‑area knowledge with ability to interpret and represent program‑level data.

Work environment

• Office‑based; ability to use digital tools, collaborate cross‑functionally, problem‑solve, and maintain availability during standard business hours.

The annual base pay for this position ranges from 323,216.00 - 484,824.00 USD Annual.Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.