Associate Director, Pharmaceutical Development (EDG-2026008)
Edgewise Therapeutics, Frankfort, Kentucky, United States
Position:
Associate Director, Pharmaceutical Development (EDG-2026008)
Location:
All US
Job Id:
242
# of Openings:
1
About EdgewiseTherapeutics At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre‑clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.
We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!
About the Position The Associate Director, Pharmaceutical Development will lead end‑to‑end development of small molecule drug products across preclinical, clinical, and commercial stages. This role involves strategic planning, technical leadership, and cross‑functional collaboration to ensure robust, scalable, and regulatory‑compliant drug product development.
In collaboration with and through active management Contract Development and Manufacturing Organizations (CDMOs), ensure that drug product supplies are available in a timely manner at various stages of clinical development and commercialization.
Essential Job Duties and Functions
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.
Required Education, Experience and Skills
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.
Travel: up to 15% (domestic and international).
Salary range: $170,000 - $200,000, title and salary commensurate with experience.
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants, a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
There is no deadline because the employer accepts applications on an ongoing basis.
Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.
#J-18808-Ljbffr
Associate Director, Pharmaceutical Development (EDG-2026008)
Location:
All US
Job Id:
242
# of Openings:
1
About EdgewiseTherapeutics At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre‑clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.
We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!
About the Position The Associate Director, Pharmaceutical Development will lead end‑to‑end development of small molecule drug products across preclinical, clinical, and commercial stages. This role involves strategic planning, technical leadership, and cross‑functional collaboration to ensure robust, scalable, and regulatory‑compliant drug product development.
In collaboration with and through active management Contract Development and Manufacturing Organizations (CDMOs), ensure that drug product supplies are available in a timely manner at various stages of clinical development and commercialization.
Essential Job Duties and Functions
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.
Required Education, Experience and Skills
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.
Travel: up to 15% (domestic and international).
Salary range: $170,000 - $200,000, title and salary commensurate with experience.
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants, a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
There is no deadline because the employer accepts applications on an ongoing basis.
Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.
#J-18808-Ljbffr