Clinical Research Scientist/ClinicianLocation: San Diego
Reporting to: Executive Director, Clinical Science
- As a Clinical Research Scientist/Clinician, this person will be responsible for the design, implementation, conduct, interpretation and reporting of clinical trials
- The candidate will work closely with other members of the Clinical Science group, Medical Directors, members of Mirati's development and Executive Leadership teams, external vendors and contract research organizations (CROs), to establish and execute the clinical development strategy for one or more compounds from lead development in discovery to Phase I-III clinical trials
- Develop and/or oversee the development of all documents required for the conduct of clinical trials
- Provide direction and participate in the selection of study investigational sites and maintain relationships with investigators and key opinion leaders
- Participate in vendor selection and oversight of full service CROs and specialty services
- Provide oversight of study conduct and integrity, data quality, planning and execution of interim and final analyses and study reporting
Qualifications and Experience:
- BS (Science degree) with 7+ years, MS/RN with 5+ years, MD or PhD with 3+ years of clinical development experience in industry setting, Oncology therapeutic area expertise preferred
- Knowledge of clinical science, clinical operations and clinical project management
- Experience with CRO oversight
- Expected competencies:
- Working knowledge of ICH/GCP guidelines
- Effective written/verbal communication (e.g. able to adjust style/contents to suit the audience/purpose)
- Ability to work independently as well as collaboratively in a multidisciplinary setting
- Ability to work well under pressure
- Ability to apply technical expertise and make sound decisions
- Ability to influence without authority
- Flexibility and willingness to adapt in a changing environment
Senior Director of Regulatory AffairsLocation: San Diego, California
Reporting: Chief Medical Officer
- Provide input into the strategies for clinical development to optimize the likelihood of successful global registration of pharmaceutical products; ensure development complies with the requirements of global regulatory authorities, including FDA, EMEA and other key countries in Asia and Latin America;
- Drive, manage and advise on preparation of all regulatory filings and completion of submissions required for maintenance of INDs and NDAs in a timely manner;
- Prepare and coordinate documentation, including investigator brochures, protocols, amendments, study reports;
- Maintain up to date knowledge of local and global legislation, guidelines and clinical practices relevant to drug development, particularly in oncology;
- Develop and maintain productive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, clarification, and follow-up of submissions;
- Negotiate with regulatory authorities in all activities leading up to submission of NDAs or BLAs as well as in all regulatory activities required to obtain registration;
- Supervise the preparation of electronic filing documents;
- Help plan and develop clinical trials and interpret trial data;
- Initiate and manage regulatory inspections as required by regulatory authorities;
- Review company practices and provide advice on changes to SOP’s and Quality Systems;
- Adhere to strict timelines and deadlines for submission of documents;
- Advising on CMC regulatory requirements.
Qualifications and Experience:
- M.S. or PhD and 7+ years direct regulatory experience in pharmaceuticals, biopharmaceuticals or the biotechnology industry;
- Recent and extensive experience with oncology regulatory filings, preferably including experience with global registration studies, including in the US, EMEA and other key countries;
- At least 2 years experience in a senior regulatory role with history of project management success;
- Prior history of working successfully in a team environment with ability to work productively with clinical development and management;
- Hands-on regulatory filing experience preparing IND and NDA submissions in either drugs or biologics;
- Strong experience with face to face interactions with global regulatory agencies and solid knowledge of current FDA regulations and guidelines;
- Excellent written and oral communication, technical writing, and editing skills;
- Strong organizational and project management skills;
- Excellent knowledge of pharmaceutical development process;
- Ability to manage multiple projects;
- Prior history of meeting deadlines and be detailed oriented.
Research Team LeaderLocation: San Diego, California Reporting: Vice President, Research
Purpose & Responsibilities:
- To build and lead a team of approximately 6 individuals with the main goal of developing comprehensive data sets enabling a clear clinical development strategy for targeted oncology programs.
- Key efforts will be directed at 1) understanding mechanisms of action for novel anticancer agents targeted agents, 2) understanding the molecular basis of sensitivity & resistance to novel targeted agents (insight toward patient selection strategy), 3) identifying strategies to reverse resistance to intrinsic or acquired resistance to agents 4) investigating the combination strategies including combinations of multiple targeted and conventional agents and to 5) identify and develop biomarkers designed to enable demonstration of pharmacodynamic effects and/or to enable patient selection.
- Longer term plans involve the expansion of this role to encompass leadership of drug discovery and preclinical development programs.
- The scope of research for this lab team is both in vitro and in vivo lab model based including correlative in vitro, ex vivo, and molecular analyses.
- The role will also develop external collaborations with academic and medical centers and with other strategic partners.
- The qualifications for this individual should enable development of an independent research program with the scope above.
- Build, lead, and directly manage a team of lab-based research scientists.
- Enable team to produce data to support clinical development strategy through clinical Proof of Concept (POC).
- Develop external collaborations with academic and medical centers and with other strategic partners.
- Multidisciplinary leadership of oncology discovery and preclinical development programs with in-depth translational work to support clinical path and strategy for POC.
Qualifications and Experience:
- PhD or MD/PhD in a relevant biological scientific discipline with a focus on cancer research and >7 years experience. Experience leading a team of lab-based sciences required.
- Relevant experience in a cancer R&D laboratory environment with biopharmaceutical/biotech experience preferred.
- Training in contemporary scientific discipline with emphasis on cancer research.
- Strong understanding of key components and process of drug discovery, applied pharmacology, and drug development.
- Strong working knowledge of oncology disease processes, disease models, and current clinical treatments.
- Experience in managing a broad scientific program utilizing relevant models and applied technologies and concepts including but not limited to genetic engineering, stable gene expression/knockdown platforms, cell and tumor biology, molecular profiling techniques, immunohistochemistry/immunocytochemistry, FACS, establishment and utilization of mouse tumor models (orthotopic, GEMMs, PDX), in vivo molecular imaging, etc.