Associate Director, Clinical Operations

Context Therapeutics Inc.; Philadelphia (Philadelphia County); Presencial; USD 150 000 - 200 000; Tempo integral

Resumo da oferta

Context Therapeutics Inc. is seeking an Associate Director, Clinical Operations to lead end-to-end oversight of clinical studies from concept through close-out.

Based in Philadelphia with a hybrid schedule, you will manage CROs and vendors to meet milestones, ensure quality data, and maintain alignment with SOPs and regulatory guidelines. You will collaborate with cross-functional teams including Project Management, Finance, Legal, and CMC to keep timelines on track, manage budgets, and mentor

Qualificações

• BA/BS degree in Life Sciences, Physical Science, Nursing, or Biological Sciences with relevant clinical trial management experience.
• Strong knowledge of regulatory guidelines and SOPs.
• Experience in biotech/pharma/medical industry preferred.
• Oncology clinical trials experience is essential.
• Excellent communication and collaboration skills.

Responsabilidades

• Oversee operational aspects of assigned clinical trial(s) from start-up to close-out.
• Ensure adherence to budgets and timelines.
• Coordinate with cross-functional teams for study milestones and data quality.
• Develop and maintain study-related documents (protocols, CRFs, etc.).
• Monitor data reviews to support dose escalation and data analysis.
• Manage vendor and CRO relationships and budgets.
• Mentor junior staff and onboard new team members.

Conhecimentos

Vendor management

Clinical trial management

Project planning

Communication skills

Cross-functional collaboration

Oncology experience

Regulatory knowledge

Interpersonal skills

Data analysis

Team mentoring

Formação académica

BA/BS in Life Sciences or related field

Ferramentas

Microsoft Project

Microsoft Office Suite

Descrição da oferta de emprego

The Associate Director, Clinical Operations will report directly to the VP of Clinical Operations and will independently oversee clinical studies from concept to close-out. The ideal candidate will ensure all clinical trial activities are performed in accordance with applicable SOPs, company policies, and regulatory guidelines. The primary focus of this role is to provide high-touch oversight to CROs and other 3rd party vendors to ensure study milestones are achieved and high-quality clinical data are delivered in a timely manner to support Context’s drug development program.

This position is based out of our headquarters in Philadelphia, PA with at least 2 days per week in the office.

Responsibilities

• Oversee operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out
• Ensure adherence to agreed budgets and timelines
• Communicate with functional peers regarding project status and issues and ensure project team goals are met
• Prepare and/or contribute to development of study-related documents e.g., protocols, IBs, Informed Consent Forms, contracts, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), eCRF Completion Guidelines, study plans, and Clinical Study Report
• Coordinate ongoing data reviews to support dose escalation decisions, interim/final data analysis
• Manage clinical trial supply for assigned clinical trials
• Review clinical study budgets, monitor budgets for variances, and approve invoices
• Develop and manage study timelines and project and track study enrollment
• Address and elevate relevant operational issues to key stakeholders
• Proactively manage potential non-compliance concerns (at a protocol level, site level, study level) and rapidly resolve or elevate appropriately
• Assist with the onboarding and mentoring of new or junior clinical operations associates

Requirements

• BA/BS degree or equivalent required in Life Sciences, Physical Science, Nursing, or Biological Sciences with at least 4 years or more years direct clinical trial management experience
• Requires clinical research operational knowledge, project planning, communication, and presentation skills. Strong expertise in vendor management required
• Experience in biotech/pharma/medical industry preferred
• Oncology clinical trial experience is a must
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment
• Experience integrating with cross-functional team members such as Project Management, CMC, Finance, and Legal
• Attention to detail and outstanding organizational skills with the ability to multi-task and adjust workload based upon changing priorities
• Display strong analytical and problem-solving skills
• Proficient in Microsoft Office Suite, experience with Microsoft Project is a plus

About Context Therapeutics®

Context Therapeutics Inc. (Nasdaq: CNTX)is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context is building an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 bispecific antibody, CT-95, a Mesothelin x CD3 bispecific antibody, and CT-202, a Nectin-4 x CD3 bispecific antibody. Context is headquartered in Philadelphia

Context Therapeutics is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.