What are the responsibilities and job description for the Senior Manager/Associate Director, Early Development and Clinical Pharmacology Operation position at Disc Medicine?
Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA.
COMPANY OVERVIEW:
Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.
POSITION OVERVIEW:
The Early Development and Clinical Pharmacology organization (EDCP) at Disc Medicine is seeking an operation manager to provide operational support to toxicology, bioanalysis, DMPK, clinical pharmacology, and other program related activities.
The operation manager will report to the SVP of EDCP. The successful candidate will work closely with EDCP leadership and functions and ensure the required plans, procedures, and activities are in place to drive successful delivering of the function or program objectives.
RESPONSIBILITIES:
Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.
COMPANY OVERVIEW:
Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.
POSITION OVERVIEW:
The Early Development and Clinical Pharmacology organization (EDCP) at Disc Medicine is seeking an operation manager to provide operational support to toxicology, bioanalysis, DMPK, clinical pharmacology, and other program related activities.
The operation manager will report to the SVP of EDCP. The successful candidate will work closely with EDCP leadership and functions and ensure the required plans, procedures, and activities are in place to drive successful delivering of the function or program objectives.
RESPONSIBILITIES:
- Partner with EDCP functions, finance, and program management to forecast and track EDCP budget
- Provide operational support to outsourcing activities, including but not limited to: request for proposal (RFP), work order (WO)/purchase order (PO) generation, invoice reconciliation, sample shipment, storage and tracking etc.
- Work with EDCP functions on data and report management
- Organize/coordinate EDCP meetings and activities as required
- Partner closely with cross functional teams, including Research, CMC, Clinical, Regulatory etc., as needed, to coordinate budget and operational activities
- Perform QC for key documents, as required
- Improve and optimize EDCP operational procedures, as appropriate
- PhD degree in relevant field with a minimum of 7 years of experience, BS/MS degree with a minimum of 10 years of experience in biotechnology/pharmaceutical industry
- General knowledge in drug research, nonclinical, and clinical development
- Excellent verbal and written communication skills
- Proficient in common office software: Word, Excel, GraphPad Prism etc.
- Highly organized with strong attention to detail
- Ability to multi-tasking
- Comfortable in working in a fast-paced environment
- Excellent interpersonal skills with proven ability to collaborate effectively with internal and external partners
- Experience with drafting and review of regulatory documents, such as IND and NDAs
- Experience managing studies with CROs
- Experience managing Quality Assurance oversight of CROs
Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.