Medical Director, MD / Neurology 6/5/2020
San Diego, CA
JOB DESCRIPTIONAPPLY WHO WE ARE:
At Neurocrine Biosciences, we pride ourselves on having a strong, distinctive 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 patient suffering and enhance lives.
WHAT WE DO:
Neurocrine Biosciences (Nasdaq: NBIX) is a neuroscience-focused, biopharmaceutical company with more than 25 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems.
The company s diverse portfolio includes two FDA-approved treatments INGREZZA (valbenazine) for tardive dyskinesia and ORILISSA (elagolix) for endometriosis*, as well as clinical development programs in multiple therapeutic areas, including Parkinson s disease, chorea in Huntington disease, congenital adrenal hyperplasia, uterine fibroids* and polycystic ovary syndrome.* As part of a strategic collaboration with Voyager Therapeutics, Neurocrine Biosciences is also focused on the development of investigational gene therapy programs for the treatment of severe neurological diseases, including Parkinson s disease and Friedreich s ataxia. (*in collaboration with AbbVie)
ABOUT THE ROLE:
Among other responsibilities, the Medical Director is responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies within cross-functional project teams (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety). Responsible for medical oversight of clinical research studies, providing necessary medical input and decisions. May work closely with Research and Preclinical Development to develop biomarkers necessary for the most effective evaluation of novel molecules. Responsible for medical oversight of Drug Safety activities in conjunction with operational activities of the Drug Safety Director. Partners with Business Development in the assessment of external innovation.
YOUR RESPONSIBILITIES (INCLUDE, BUT ARE NOT LIMITED TO):
Develops and implements study protocols as in conjunction with a multidisciplinary Development Team.
Assist in the identification and selection of clinical investigators for clinical trials and maintain appropriate communication and professional relationships as Sponsor medical monitor/representative.
Conduct medical assessment and disposition of adverse events (in conjunction with Drug Safety physician) and evaluate safety of clinical compounds prior to and during ongoing clinical studies.
Oversee the clinical trials program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations.
Analyze, interpret, and present results of clinical studies to internal and external audiences as directed by Sr. Management;
Identify resource requirements, assist in budget planning and personnel forecasting for clinical research programs;
Assists in the recruitment, training and development of the clinical teams.
Identify and select clinical consultants.
Provide or assist in the scientific writing and review of clinical study reports and related regulatory documents;
Provides periodic status updates and effectively communicates with Senior Management Team.
Leads the development of clinical biomarker strategies for clinical development.
Work with Medical Affairs and external opinion leaders to secure new collaborators and present trial results;
Interface with Research, Product Development and Business Development to assess new product opportunities, develop clinical research strategy and product development plans;
Other duties as assigned.
* MD or DO degree with accredited residency training and board certification in relevant clinical specialty for the therapeutic area required and 5+ years of experience in clinical research and development (Phase 1-4) in either a pharmaceutical/biotechnology company or a clinical research/academic environment or related experience required.
* Knowledgeable in Good Clinical Practice, regulatory procedures relevant to investigational drug development
* Strong knowledge in translational medicine and biomarker evaluation, clinical study execution, regulatory requirements and documents, study design, biostatistics, data analysis, report writing, and scientific presentation of data
* Demonstrated effectiveness as Clinical Lead on a program, operating in a multi-level matrix corporate environment, requiring interaction with, and/or direction of clinical research project teams, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel
* Demonstrated success managing interactions with external CROs, consultants and other contract organizations, especially from the context of a small group
* Proven track record of success across all phases of drug development, proven success record in clinical trial design
* Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
* Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
* Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact
* Strong interpersonal and communication skills as well as strong organizational and team leadership skills are required
* Able to work independently and prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment
Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.