Leading clinical-stage oncology company is seeking a Director of CMC Development to join its growing team.

Our ideal candidate will be a strong scientist with biopharmaceutical experience who can collaborate with members of cross-functional teams to prepare high-quality protocols, protocol amendments, investigator brochures, synopses, regulatory documents such as INDs and BLAs, clinical publications, and related clinical documents within agreed-upon timelines.

Key Essential Functions:

• Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts, integrating inputs from other team members into a cogent fit-for-purpose whole.
• Participates in scientific communication planning, including development of strategic medical communication plans
• Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
• Manages the corporate EndNote 9 shared bibliographic library
• Manages all aspects of outsourced or internal CSR production and ensures project delivery
• Partners with other clinical team leaders including participation in the review of mock and/or blinded tables, figures, and listings (TLFs), and narrative planning for relevant documents
• Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
• Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
• Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
• Works closely with QA to maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
• Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements

Required Skills & Abilities:

• Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
• Broad experience managing the medical writing responsibilities associated with multiple studies at various stages and across various functional teams
• Ability to work independently with minimal supervision, multi-task, and work effectively under pressure in a virtual R&D organization; adapt to change as needed; possess excellent project management skills; attentive to details
• Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
• Track record of increasing responsibility and independence in a similar role in pharmaceutical drug development
• Strong computer skills, including use of EndNote 9 within MS Word for references management

Required Qualifications:

• Bachelor’s degree +8 years, Master’s Degree +5 years, Doctoral Degree +2 years of relevant medical writing experience in the pharmaceutical industry, especially writing in oncology; graduate degree (masters or doctoral) preferred. Title will be commensurate with experience.
• Proven successful experience with writing INDs, Clinical protocols, Clinical study reports, Investigator Brochures, regulatory correspondence, and/or NDAs/BLAs and peer-reviewed journal articles.