Website GPCR Therapeutics USA
Clinical Medical Director–Oncology GPCR THERAPEUTICS, USA 2021
Located in San Carlos, CA and in S. Korea, GPCR Therapeutics, Inc. http://gpcr.co.kr, is a venture backed startup company developing pharmaceuticals based on the cutting-edge technology of G Protein-Coupled Receptors (GPCRs). The company has discovered specific GPCR heteromers which when formed result in enhanced signaling. The company is developing drugs targeting disease-specific heteromers in cancer.
A Phase IIa clinical asset, Burixafor, a small molecule inhibitor of CXCR4, has been acquired. We are looking for an experienced Medical Director to play a key role in clinical development of our first lead compound. Serving as the lead medical clinician in the company and reporting to the CSO, the Medical Director will take on a leadership role overseeing the strategic direction and execution of our clinical development program. In this role you will have a broad impact on both the company direction and on patients.
Roles & Responsibilities
Oversee and lead the strategic direction of the company’s clinical studies (initially a Phase IIa trial in the US).
Lead the study design of clinical trials and be a major contributor to the writing of protocols, identifying clinical trial sites, design of data collection, interpretation of clinical data and preparation of final clinical study reports.
Serve as the main contributor to regulatory strategies and work closely with the FDA to submit new clinical study plans and be responsible for all correspondences.
Work closely with our selected clinical CRO to oversee strategy, scope, complexity, size, budget, and deliverables, the clinical development strategy and clinical development plan. Support delivery and continual assessment of a plan that is competitive and consistent with current regulatory requirements, and development of appropriate contingency plans.
Working closely with a Medical Monitor and CTC, oversee the clinical operations functions and activities related to the execution of clinical studies and programs in accordance with company SOPs, FDA guidelines and regulations.
Working closely with the Medical Monitor and CTC, oversee the successful execution of clinical trials, programs, timelines, budgets and clinical milestones.
Oversee data collection activities and clinical response information.
Supervise a clinical monitor and project manager.
Engage with our scientific advisory board, key academic, community, and industry partners, and other thought leaders to innovate and refine clinical development strategies.
Education and Experience
Board certified MD preferred, but not required and a minimum of 3-5 years of biotechnology or pharmaceutical or academic clinical drug development experience.
Experience in oncology is required, and expertise in hematological cancers is highly desirable.
Experience with running clinical trials as a Principal Investigator (PI) or sub (PI) is essential.
Experience in drug safety or pharmacovigilance is preferred.
Experience in supervising medical monitors is a plus.
Experience working with health authorities in outcome measures, presentations, negotiations and submissions are highly desirable.
Extensive experience with writing clinical study reports and interpreting clinical data.
Extensive knowledge of clinical trial strategy, design, execution, regulatory and compliance (GCP, ICH, etc.) requirements governing clinical trials.
Phase I, II and III clinical trial experience in the pharmaceutical industry, academia, or equivalent.
Strong collegial and interpersonal skills and ability to work effectively with teams.
Ability to communicate effectively both orally and in writing in an inter disciplinary environment.
Ability to work in a small and growing company and be comfortable in a startup environment.
Highly motivated, self-starter who can take initiative.
Excellent analytical and problem-solving skills.
Highly tolerant and respectful of all members of a small startup company.
Focused and goal-oriented, yet flexible enough to deal with unanticipated challenges and opportunities.
Ability to interact externally and internally to support a global clinical and scientific strategy.
Must be flexible, and able to prioritize objectives.
Ability to exercise good scientific, clinical and ethical judgement to proactively identify and address complex problems.
Possible occasional travel to S. Korea.
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