Job Description

About Us:

At BlossomHill Therapeutics, we are on a mission to redefine precision medicine and make a leap forward in life expectancy and quality of life for patients. Our cancer therapies are exquisitely designed to be potent against cancer drivers and aim to address cancer’s resistance to treatment from multiple angles. Our autoimmune programs seek to tackle difficult challenges to deliver life-changing therapies for patients.

Driven by a desire to transcend incremental improvements to existing drugs, we approach drug design from the ground up. Combining human intelligence, creative thinking, and proven drug design expertise, we are dedicated to developing small-molecule masterpieces that have the potential to set new standards for cancer and autoimmune disease treatment.

Job Summary:

The Clinical Scientist/Senior Clinical Scientist plays a critical role contributing to the execution and interpretation of BlossomHill’s clinical trials. This team member will provide clinical and scientific expertise to internal teams (clinical operations, regulatory affairs, biometrics, pharmacovigilance, and translational) to ensure timely and high-quality clinical development deliverables. The ideal candidate will have experience in oncology, particularly with hematologic malignances, and will engage extensively with external stakeholders. This position reports to the SVP, Clinical Development, and will support a cross functional clinical development team. San Diego location is preferred.

Key Responsibilities:

• Ensuring high quality clinical trial conduct and data collection, in collaboration with clinical operations.
• Drafting clinical sections of study reports, investigator brochures, responses to regulatory authorities and other key clinical and regulatory documents.
• Contribute to the generation, review and implementation of clinical protocols, Informed Consent Forms and operational study documents.
• Contribute to the ongoing review, interpretation, and reporting of clinical trial data to ensure data quality and identify data trends.
• Support the clinical development lead in the preparation and review of regulatory documents, publications and other external scientific data communications.
• Support Clinical Development leadership participating in clinical/medical advisory panels, steering committees and investigator meetings, etc.
• Support medical monitoring activities including addressing questions from study sites, in conjunction with the clinical development lead.
• Monitor study progress, ensuring that studies observe the highest standards of ethical and safe conduct, and ensure compliance with GCP

Qualifications:

• Advanced degree training such as PhD, PharmD, RN or MD.Strong clinical trial research background; experience in oncology and specifically hematologic malignancies highly preferred.
• 5+ years of experience within biotech or pharmaceutical industry or equivalent.
• Experience in the submission of IND/NDA/BLAs as well as interactions with regulatory authorities (US and other regions) is preferred.
• Strong working knowledge of GCP regulations.
• Excellent analytical and writing skills, ability to describe complex issues in a simple way through written and oral communication, and ability to orchestrate plans to resolve issues and mitigate risks.
• Ability to work independently in a highly collaborative, fast-paced environment.
• Ability to travel as needed.

AAP/EEO Statement:

The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Recruiters and Agencies:

BlossomHill Therapeutics does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to BlossomHills’ employees is strictly prohibited. Unsolicited referrals and resumes sent to BlossomHill Therapeutics are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired.

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