Associate Director, Clinical Science

Associate Director of Clinical Science (Clinical Development)

Job Responsibilities:
- Develop/oversee study concept synopses and protocols using clinical trial design knowledge.
- Participate in protocol review discussions (scientific and procedural aspects).
- Collaborate with Medical Writing and Clinical Operations to prepare study protocols, amendments, study manual sections, and investigator meeting materials.
- Contribute to CRF, Data Management Manual, and Data Analysis Plan design/review.
- Review ongoing clinical data.
- Organize/oversee Data Review Committee meetings and prepare review/meeting materials.
- With MD supervision, address investigator scientific/procedural questions.
- Contribute to preparation/review of data listings, summary tables, study results, manuscripts, and presentations.
- Assist with/review INDs, regulatory documents, IND annual report/DSURs, Investigator Brochures, and NDAs/MAAs.
- Support functional area priorities; anticipate and help solve moderately complex clinical study obstacles.
- Coordinate teams/provide direction; may lead 2+ components of departmental strategic initiatives.
- Enter new therapeutic areas and integrate published scientific information into study development.
- Travel: 20%.

Qualifications:
- MS with 6+ years relevant drug development experience OR BS (Biological Sciences/healthcare/related) with 8+ years.
- Minimum 5 years clinical research or clinical pharmacology experience (biotech/pharma or CRO).

Preferred Qualifications:
- PharmD or PhD.

Skills/Qualifications:
- Fast learner; flexible/adaptable; ability to apply AI to improve execution/decision-making.
- Proficiency with Microsoft Office (Excel, PowerPoint) and tools such as SpotFire.
- Knowledge of FDA, EMA, and ICH regulations.
- Strong verbal/written communication and cross-functional collaboration.

Application instructions:
- If you’re intrigued but don’t fully match, you are encouraged to apply anyway.