Senior Medical Director - NASH Biotech - Northeast - Michael Page : Job Details
Senior Medical Director - NASH Biotech - Northeast
Michael PageJob Location : Philadelphia,PA, USA
Play a crucial role in their clinical development team, providing strategic medical leadership in the development of novel drugs and therapies. Responsible for US Clinical development and drug safety, you will offer medical guidance to discovery projects, ensuring the highest standards of clinical research. This includes designing clinical trials.
Client Details
My client is a clinical-staged biotechnology company which develops drugs and therapies across the metabolic and immune-related disease spaces. The organization has a variety of programs in different stages. They recently finalized a 1 billion dollar deal with a global Pharma company to help develop their novel therapies. They are Chinese based and growing their business in the United States, with plans build a US office in the near future. This is a fully remote role, with a strong preference of the candidate being in the Northeast.
Description
As a Senior/Executive Medical Director, you will play a crucial role in their clinical development team, providing strategic medical leadership in the development of novel drugs and therapies. The successful candidate will be responsible for US Clinical development and will offer medical guidance to discovery projects, ensuring the highest standards of clinical research.
Clinical Development Leadership:
- Lead and oversee the clinical development strategy for projects related to metabolic and immune-related diseases.
- Provide medical input to guide the design and execution of clinical trials, ensuring adherence to regulatory requirements and industry best practices.
Protocol Development:
- Write and/or review clinical protocols and other essential documents to support IND filings and regulatory activities.
- Collaborate with cross-functional teams to ensure protocols align with clinical development objectives.
- Provide safety oversight and pharmacovigilance management to clinical development
Regulatory Compliance:
- Work closely with regulatory affairs to ensure compliance with regulatory requirements throughout the development process.
- Provide medical expertise during regulatory interactions and submissions.
Team Collaboration:
- Collaborate with internal teams, including clinical operations, data management, and biostatistics, to ensure seamless execution of clinical trials.
- Act as a medical resource and mentor to other team members.
Scientific Input:
- Stay abreast of advancements in metabolic and immune-related diseases, contributing scientific insights to guide project strategies.
- Contribute to the development of scientific publications and presentations.
Profile
- Medical degree (MD or equivalent) with relevant clinical development experience.
- At least 10+ years of experience in industry specific role, preferably Biotech or Big Pharma
- Extensive experience in clinical science, clinical research, drug safety, metabolism, diabetes, endocrinology. or other non-oncology focused areas.
- Board certification in a relevant therapeutic areas is highly desirable.
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
- Proven experience in the design and execution of clinical trials, preferably in metabolic and immune-related diseases.
- Excellent communication and leadership skills, with the ability to collaborate effectively in a remote work environment.
- Prior experience working in a biotechnology or pharmaceutical company is preferred.
Job Offer
- Competitive base salary
- Fantastic culture: team made up of science-driven and passionate individuals
- Reporting to Clinical Operations Head
- Fully remote position
- Excellent benefits package
- Ample opportunity for career growth
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.