- Serve as the Clinical Lead for one or more pipeline products
- Develop and/or assist in the production of clinical documents required for the conduct of clinical studies, such as clinical protocols, informed consent documents, investigator's brochures, and miscellaneous study management plans in compliance with federal regulations and good clinical practices
- Provide ongoing data interpretation and medical writing of study reports, conference abstracts, and manuscripts for publication
- Safety data review and management of internal/external data monitoring committees
- Prepare or assist with clinical sections of key regulatory documents, e.g., IND annual reports and briefing packages
- Represent clinical development on internal multidisciplinary project teams
- Present clinical program at Site Initiation Visits, Investigator's Meetings, and scientific conferences
- Lead teleconference and/or face-to-face meetings with Investigators
- Partner with Clinical Operations to drive key deliverables
- Provide clinical development review of potential in-licensing opportunities
- Provide direct management, leadership and mentoring of other junior Clinical Development team members
- Perform all duties in keeping with the Company's core values, policies and all applicable regulations
- MD, PhD, MD/PhD with 5+ years of clinical development experience in industry setting preferred; MS/RN/PharmD with 10+ years or BS (Science degree) with 15+ years
- Oncology therapeutic area expertise; experience in solid tumors, particularly lung cancer and/or prostate cancer highly desirable
- Phase 1-3 studies with experience with translational medicine, precision oncology, global studies, from early development through NDA highly desirable
- Expected competencies: ICH/GCP guidelines
- Effective written/verbal communication (eg, able to adjust style/contents to suit the audience/purpose; includes public speaking)
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Director, Clinical Development
1 day ago
Neurocrine Bioscience San Diego, United StatesWho We Are: · At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering ...
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Director, Clinical Development
1 week ago
Neurocrine Biosciences Inc. San Diego, United StatesWho We Are: · At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering ...
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VP, Clinical Development
1 week ago
Mirador Therapeutics, Inc. San Diego, United States Full time(San Diego, CA) · Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company's Mirador360 TM precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precisio ...
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VP, Clinical Development
1 week ago
BioSpace, Inc. San Diego, United StatesYou will need to login · before you can apply for a job. · Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company's Mirador360 TM precision development engine leverages the latest advances in human genetics and cutting-edge da ...
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VP Clinical Development
1 week ago
Erasca, Inc. San Diego, United StatesErasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MA ...
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Vice President of Clinical Development
1 week ago
Avetix Group San Diego, United StatesPurpose of Role: · The role is responsible for the development of clinical research strategies and direction of Phase 1-3 clinical studies while working with cross-functional project teams. S/he will be responsible for study design, development, data readout, and summary. This p ...
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Vice President, Clinical Development
1 week ago
Longboard Pharmaceuticals, Inc. San Diego, United StatesJob Description · Job Description · Job Title: · Vice President, Clinical Development · Reporting To: · CMO · Department : R&D Management · People Manage r: Yes · FLSA Status: · Exempt · Location: · La Jolla, CA · Company Background · Longboard Pharmaceuticals, Inc. is a c ...
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Vice President, Clinical Development
1 week ago
Longboard Pharmaceuticals San Diego, United StatesJob Title: · Vice President, Clinical Development · Reporting To: · CMO · Department : R&D Management · People Manage r: Yes · FLSA Status: · Exempt · Location: · La Jolla, CA · Company Background · Longboard Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical ...
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Clinical Development Medical Director
1 week ago
Brio Group San Diego, United StatesMedical Director - Clinical Development & Research · Plainsboro, NJ 08536 · posted 04/29/2024 · More... · front runner · Clinical Development Medical Director (SR/ED/VP) · Brio Group · CA · posted 05/01/2024 · More... · front runner · Medical Director, Clinical Development ...
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Vice President Clinical Development
2 weeks ago
Trebla Talent San Diego, United StatesAbout the job · Role: · Vice President, Clinical Development · Remote - USA · Company Description: · We are working with a ~60-person clinical-stage biotech, committed to transforming the lives of patients affected by Neurological and Rare Diseases. Having recently gone public ...
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Senior Director, Clinical Development
2 weeks ago
ORIC Pharmaceuticals, Inc. San Diego, CA, United StatesORIC Pharmaceuticals, Inc, is a clinical stage oncology company dedicated to improving patients' lives and focused on developing treatments that address mechanisms of therapeutic resistance. We are seeking an accomplished clinical development leader who will be responsible for Im ...
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Vice President, Clinical Development
1 week ago
Mirador Therapeutics San Diego, United StatesWe are building a next-generation precision medicine company focused on immunology and inflammation. The company's · Mirador360 · precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicine ...
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Director, Early Clinical Development
2 weeks ago
Bristol Myers Squibb San Diego, United States Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
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Rbw Consulting San Diego, United StatesSenior/Executive Medical Director, Clinical Development · RBW is partnered with a well-funded US based biotech with a startup environment. This biotech focuses on Endocrine and Metabolic Disorders and is looking to potentially expand into other areas. Following positive data in ...
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RBW Consulting San Diego, CA, United StatesSenior/Executive Medical Director, Clinical Development · RBW is partnered with a well-funded US based biotech with a startup environment. This biotech focuses on Endocrine and Metabolic Disorders and is looking to potentially expand into other areas. Following positive data in ...
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Discovery Senior Living San Diego, CA, United StatesJob Description · Job Description · About Discovery Senior Living · Discovery Senior Living ranks prominently among the 5 largestsenior housing providers in the US, and is nationally renowned for designing,developing, marketing, and operating a multi-brand portfolio of upscale ...
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Discovery Senior Living San Diego, United StatesJob Description · Job DescriptionAbout Discovery Senior Living · Discovery Senior Living ranks prominently among the 5 largestsenior housing providers in the US, and is nationally renowned for designing,developing, marketing, and operating a multi-brand portfolio of upscale, luxu ...
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Neurocrine Biosciences Inc. San Diego, United StatesWho We Are: · At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering ...
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BioSpace San Diego, United StatesJob Details · Job Type Full-time · Position Summary · This position will be primarily responsible for providing strategic and scientific leadership for the Rheumatology Therapeutic Area clinical programs as well as setting the clinical strategy for approved products and being in ...
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Viking Therapeutics San Diego, United Statesread more " · Purpose of Role: · The Medical Director is responsible for the development of clinical research strategies and direction of Phase 1-3 clinical studies while working with cross-functional project teams. S/he will be responsible for study design, development, data rea ...
Senior Director, Clinical Development - San Diego, United States - ORIC Pharmaceuticals Inc
Description
ORIC Pharmaceuticals, Inc, is a clinical stage oncology company dedicated to improving patients' lives and focused on developing treatments that address mechanisms of therapeutic resistance. We are seeking an accomplished clinical development leader who will be responsible for Implementation of clinical development plans, focusing on innovative clinical trial design, study execution and data interpretation and communication. A deep knowledge of Oncology clinical development, combined with scientific knowledge, critical thinking, active listening, complex problem solving, and decision-making abilities, are critical skills for this position.
Interacts with Research and other internal departments, such as Finance, and with external parties, including clinical collaborators, third-party vendors, and contract research organizations (CROs), with the objective of establishing and leading the clinical development strategy for one or more of ORIC's clinical development programs.
The successful candidate will report to the Senior VP, Clinical Development and will be responsible for the following.
The anticipated salary range for candidates in San Diego is between $250,000-$300,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. ORIC is a multi-state employee, and this salary range may not reflect positions that work in other states.
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