Scientist, Clinical and Translational
Clinical Development | Berkeley, CA | Full Time
Plexxikon, a member of the Daiichi Sankyo Group, is a leader in the discovery and development of novel, small molecule pharmaceuticals. The company utilizes its proprietary discovery platform to successfully develop a portfolio of competitively differentiated clinical and preclinical stage compounds in a number of therapeutic areas. Plexxikon’s first marketed drug, Zelboraf™ (vemurafenib) was the first precision medicine to be approved for the treatment of BRAF-mutant metastatic melanoma. Plexxikon's demonstrated capability in discovery and early development uniquely positions the company to develop multiple commercial franchises for different therapeutic indications, and to create significant value for Plexxikon, Daiichi Sankyo and its collaborators. Plexxikon's novel discovery approach, combined with experienced management and scientific teams, a broad network of scientific and clinical experts, and partnerships supporting later stage development, have been key drivers of the company's success since it began operations in 2001. Plexxikon is a small business with approximately 65 employees based in Berkeley, California.
The Scientist will be a critical member of the clinical team reporting to the VP, Clinical Development. This is an exceptional opportunity to gain experience in translational and clinical science in a successful, fast-paced biotech company. In this role, you will participate in the creation of translational and clinical development strategy; analyze, summarize and present Phase 1/2 translational and clinical study data; draft study protocols and sections of key regulatory documents; engage internal and external teams cross-functionally; serve as global clinical/translational science lead for one or more clinical stage programs.
Responsibilities include, but are not limited to:
- Data Analysis: Collaborates with translational pharmacology, DMPK, and clinical operations to ensure appropriate biomarker, PK / PD measurements; Analyzes, reviews and summarizes emerging clinical and translational data including Next Generation Sequencing (NGS), clinical safety and efficacy data from ongoing clinical studies; Prepares molecule-level summaries for safety and medical data review meetings
- Strategic Planning: Provides strategic direction for data quality listings, SAP, and DM plan; Assists with clinical indication and protocol planning; Develops biomarker strategy in collaboration with translational science and pharmacology; Participates in regulatory strategy meetings as requested; partners with project management to maintain alignment with company objectives
- Discovery Pipeline Continuity: Bridges discovery and translational pharmacology with clinical science and development; Creates early development plan beginning from First-In-Human (Ph1) and contributes to overall clinical and translational development strategy; Develops program biomarker strategy; Achieves endorsement for plan by function and team; Interprets and responds to new preclinical/clinical data(e.g.; Go/No Go decisions, reprioritization, etc.)
- Clinical Trial Oversight: Provides input on major milestones for clinical trials and develops contingency plans; Provides input on ICF creation, protocol amendments, and regulatory documents; Manages CRO for planned PD studies; Reviews TLFs before database lock
- External Collaboration: Together with the clinical lead, develops and conducts external calls and meeting to advise early clinical development study strategy and design; Interacts with KOLs for indication specific advice; Participates in the drafting of scientific publications
- Conduct other duties as assigned
Position Requirements & Experience:
- Doctorate degree, PharmD in or equivalent with prostgraduate training in oncology or related speciality with 1-4 years of relevant experience including clinical trial conduct, clinical data collection, analysis, and interpretation
- Demonstrated ability to analyze Next Generation Sequencing data including RNA-seq
- Proven track record of scientific publications
- Demonstrated technical proficiency, scientific creativity, problem solving ability, and capable of independently planning and executing functional genomic data and clinical data analysis
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative and multi-disciplinary team work environment
- Highly motivated and able to work in a fast-paced environment with a desire to learn and tackle new challenges
- Candidates must be authorized to work in the U.S.
Plexxikon is located in Berkeley, just off interstate 80. We offer a chance to work with talented people in a collaborative environment and provide top-notch benefits including health insurance, generous time off and much more. As an equal opportunity employer, Plexxikon is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
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