Sr. Medical Director (MD), Translational and Experimental Medicine, Metabolic

Neurocrine Biosciences • San Diego, CA

4d

About The Position

Medical expert responsible for the development of translational and early clinical research strategies and independent direction of Phase 1 and early Phase 2 (first-in-human and early proof-of-concept) clinical studies while working with cross-functional project teams (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety). Responsible for the creation and execution of early clinical development plans that advance innovative therapies, particularly in metabolic disorders including but not limited to disorders affecting the endocrinological, immunologic, and/or neurologic systems. Provides expert medical and scientific advice to advance the early development portfolio and help navigate the complex translational drug development landscape. Works closely with Research and Preclinical Development to develop and implement biomarkers and experimental medicine approaches necessary for effective evaluation of novel molecules in early human studies.

Requirements

• MD or DO (or equivalent) degree in relevant clinical specialty for the therapeutic area required and 4+ years clinical experience with broad bio/pharmaceutical/CRO industry experience in drug development
• Accredited residency training and board certification preferred
• Recognized internal thought leader with deep expertise in translational medicine and early clinical drug development
• Requires broad, deep, and comprehensive expertise in leading-edge translational and experimental medicine approaches, including biomarker development and validation, PK/PD modeling, and mechanistic interrogation of drug action in humans
• Demonstrated industry experience in metabolic disorders, including but not limited to disorders affecting the endocrinological, immunologic, and/or neurologic systems
• Strong experience designing and leading first-in-human and early proof-of-concept studies in relevant patient populations
• Applies ingenuity and creativity to problem analysis and resolution in complex and/or novel translational development situations
• Influences internal/external scientific and business discussions that impact early development strategy
• Proven ability to translate translational strategy into tactical early clinical plans and drive outcomes
• Strong interpersonal and collaborative skills; proven track record building relationships and engaging in scientific discourse with medical and scientific experts
• Outstanding oral and written communication skills, with close attention to detail; ability to translate complex mechanistic concepts into language tailored for different audiences
• Deep knowledge and understanding of the drug development process, particularly early-stage regulatory requirements (e.g., IND-enabling strategy), clinical pharmacology, and Good Clinical Practice
• Strong knowledge in translational medicine, biomarker evaluation, early clinical study design, biostatistics, data analysis, report writing, and scientific presentation of data
• Able to effectively operate in a multi-level matrix corporate environment requiring interaction with physicians, scientists, clinical research teams, regulatory, and consultant personnel
• Demonstrated success managing interactions with external CROs, consultants, and other contract organizations
• Has successfully driven early development program strategy and execution within Clinical Development

Responsibilities

• For assigned programs, develops translational and early clinical development strategies and is accountable for the study design of Phase 1 and early Phase 2 clinical trials, leading preparation of clinical study synopses and serving as a major contributor to the writing of protocols/major amendments, the design of data collection systems, interpretation of clinical and biomarker data, and preparation of final clinical study reports. Engages with external experts and organizations as needed to achieve these aims
• Represents Medical/Clinical on the cross-functional Program Team as the Translational Medicine Lead. Accountable and responsible for the medical input to integrated development plans prepared by the Program Team, with primary emphasis on first-in-human and early proof-of-concept strategies
• Provides medical leadership to the Program Team and is accountable for driving execution of the early clinical development plan
• Develops and implements study protocols in conjunction with a multidisciplinary Development Team, incorporating mechanistic endpoints, target engagement measures, pharmacodynamic assessments, and biomarker strategies to interrogate drug action in humans
• Partners closely with Research and Preclinical Development to translate preclinical pharmacology, disease biology, and mechanistic hypotheses into early clinical testing strategies, including dose selection and PK/PD modeling approaches
• Assist in the identification and selection of clinical investigators for early phase 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 early clinical studies
• Oversee the early clinical trials program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations
• Identify resource requirements, lead budget planning and personnel forecasting for early clinical research programs; contribute to recruitment, training, and development of clinical teams and identify/select clinical consultants as needed
• Lead the analysis, interpretation, and presentation of results of assigned early clinical studies to internal and external audiences, with emphasis on translational insights and data-driven decision making
• Work with Medical Affairs and external opinion leaders to secure new collaborators and present early translational and proof-of-concept results
• Interface with Research, Product Development, and Business Development to assess new product opportunities and develop translational and early clinical research strategies
• Other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree