Associate Director, Clinical Science

Job not on LinkedIn

November 9

❄️ Minnesota – Remote

Although this job is listed in Minnesota, this company may be open to hiring remote in other states.

💵 $190k - $230k / year

⏰ Full Time

🟠 Senior

👔 Director

Apply Now

Receive Emails with Similar Jobs

Celcuity

WebsiteLinkedInAll Job Openings

Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Review clinical data and ensure quality and consistency in clinical site reporting • Develop and review Clinical Development documents including writing, reviewing, adjudication/resolution of cross functional comments and ensuring a high-quality final document. Documents may include abstracts, manuscripts, clinical protocols/amendments, informed consent forms, regulatory documents, and other relevant materials. • Develop and review presentations and training materials such as slide decks, posters, or other relevant materials • Participate in the relevant Clinical Development Core Team and Clinical Sub-Team meetings as needed • Interface with Biostatistics, Data Management, Clinical Operations, Project Management, Quality Assurance, Regulatory Affairs, and other members of the extended project team(s) • Represent Clinical Science in operational meetings (e.g., Study Management Team meetings) as needed. • Maintain scientific and clinical knowledge in the relevant therapeutic and disease area(s)

🎯 Requirements

• Advanced Science/Clinical Degree is preferred (e.g., PhD, PharmD, MD) • 3 or more years clinical trial experience in pharma/biotech industry setting • Oncology research experience preferred • Data listing review experience is mandatory • Experience authoring experimental protocols and/or study results and conclusions • Strong understanding of Phase 1 through 4 drug development • Excellent comprehension and analytical skills in interpreting scientific research and literature • Sound knowledge of scientific and medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant health authority guidelines and regulations • Strong understanding of product and safety profiles • Working knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g. clinical operations, biostatistics, data management, regulatory, medical affairs, etc. • Excellent time/project management skills: can prioritize multiple tasks to meet short and longer-term goals with high quality standards and in a timely manner • Strong oral and written communication skills, including interpersonal interactions, internal and site-directed communications and internal and external presentation skills • Good judgment and decision-making skills.

🏖️ Benefits

• medical, dental, vision insurance • 401(k) match • PTO • paid holidays