Job Description
Beacon Hill Biomedical is seeking a visionary Clinical Research Director to lead our late-stage oncology programs in the heart of Boston's premier life sciences hub. This high-impact role requires a blend of scientific expertise, strategic leadership, and a passion for patient-centric innovation. You will be at the forefront of developing life-saving therapeutics, overseeing complex global trials from conception through regulatory approval.
The ideal candidate is a strategic thinker with a proven track record in the biotechnology sector, capable of navigating the intricacies of clinical development while fostering a culture of excellence and integrity.
Responsibilities
- Oversee the strategic design, planning, and execution of Phase II and III clinical trials within the oncology therapeutic area.
- Collaborate directly with global regulatory bodies, including the FDA and EMA, to ensure rigorous compliance and expedite the submission process.
- Lead and mentor cross-functional teams comprising clinical scientists, data managers, and medical monitors.
- Direct the selection and management of Contract Research Organizations (CROs) and external site investigators to ensure trial milestones are met.
- Analyze and interpret complex clinical data sets to drive evidence-based decision-making for drug development programs.
- Present pivotal clinical data and trial progress to the executive leadership team and at international medical conferences.
Qualifications
- MD, PhD, or PharmD with a specialization in Oncology or a related biological science.
- Minimum of 8 years of clinical development experience within the pharmaceutical or biotechnology industry.
- Demonstrated success in leading multiple clinical programs through successful IND/NDA/BLA submissions.
- In-depth knowledge of GCP, ICH guidelines, and international regulatory requirements for clinical trials.
- Exceptional leadership capabilities with a history of managing high-performance clinical teams.
- Strong analytical mindset with the ability to translate complex scientific data into strategic clinical plans.
- Excellent verbal and written communication skills for effective stakeholder engagement.