Edgewise Therapeutics · 1 day ago
Associate Director, Pharmaceutical Development (EDG-2026008)
United States
Full-time
Remote
Lead/Staff, Director/Executive
$170K/yr - $200K/yr
10+ years expEdgewise Therapeutics is dedicated to discovering new medicines that enhance the lives of patients with serious muscle diseases. The Associate Director, Pharmaceutical Development will lead the end-to-end development of small molecule drug products, ensuring regulatory compliance and collaboration with internal and external stakeholders throughout the product development stages.
BiopharmaBiotechnologyHealth Care
Responsibilities
Lead formulation strategy, prototype selection, and process development for small molecule drug products (focus on OSDs; include enabling formulations if needed—amorphous solid dispersions, lipid-based systems, salts/co-crystals)
Manage drug product CDMOs and collaborate with internal stakeholders in the development of small molecule drug products, including technical, logistical and project management aspects to ensure program timelines are met
Develop and implement comprehensive strategies for process development including solid form characterization, evaluation of multiple formulation options, process design and optimization, scale-up, and manufacturing of drug product (DP) under both non-GMP and cGMP to enable pre-clinical and clinical studies, respectively
Provide in-depth technical expertise in support of CMC regulatory submissions, due diligence, and other appropriate regulations and guidelines, and active participation in establishment and justification of specifications
Contribute to company strategy by formulating appropriate CMC objectives and priorities in collaboration with the team and drive these objectives and goals through a superior level of scientific knowledge and innovative technical skills
Research and identify new opportunities outside of assigned work that augment the company’s mission, vision, values, and goals
Communicate professional insight and company’s position on CMC issues to internal stakeholders and external partners
Influence collaborators and consultants by demonstrating a deep understanding of all aspects of the company’s projects, data, results, and objectives
Provide critical evaluation of CMC team deliverables, constructively challenging assumptions and offering well-reasoned insights and practical solutions
Drive implementation of new technologies and approaches in formulation and process development
Work across internal departments to maintain credibility, trust, and support of employees and other stakeholders
Demonstrate leadership and professionalism to build external relationships crucial to the success of the organization
Maintain scientific records in clear required form
Update job knowledge by participating in educational opportunities; reading professional publications; maintaining professional networks; and participating in professional organizations
Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures
Perform other duties as assigned by supervisor
Qualification
Required
Ph.D. in Pharmaceutics or scientifically related field or M.S. with additional professional experience
10+ years of related small molecule drug product development and manufacturing experience in CMC/cGMP environment
3+ years of management and oversight of CDMOs for non-GMP and cGMP activities from preclinical through Phase 3
Ability to navigate and craft global regulatory CMC documents
Subject matter expert with exceptional command of scientific literature in the field and related disciplines
Familiarity with QbD principles and risk-based development approaches
Ability to work in a fast-paced, matrixed environment
General and scientific computer and software application proficiency
Benefits
Health benefits
A discretionary bonus plan
Stock option grants
A stock purchase plan
A 401(k) with match
Paid time off
Company
Edgewise Therapeutics
Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$738.5MKey Investors
Viking Global Investors
2025-04-02Post Ipo Equity· $200M
2024-01-19Post Ipo Equity· $240M
2022-09-13Post Ipo Equity· $138M
Leadership Team
Alan Russell
Co-Founder & Chief Scientific Officer
R.Michael Carruthers
Chief Financial Officer
Recent News
2026-01-14
MarketScreener
2025-12-25
Company data provided by crunchbase