Sr. Director, Clinical Development

About the role

Responsible for leading development and execution on strategy and plans for Phase 1-3 clinical studies while working with a multidisciplinary team (R&D project teams, clinical project managers, statisticians, data management, regulatory, drug safety).

As needed, interfaces with Research, Translational and Experimental Medicine and Business Development to assess new product opportunities, develop clinical research strategy and product development plans.

Responsibilities

• Directs and provides strategic guidance for Phase 1-3 Clinical Trials for the clinical development in accordance with Neurocrine SOPs and GCP guidance
• Leads the development and implementation of Clinical Development Plans and Study Protocols consistent with the Development Team direction
• Lets the clinical team in the identification and selection of clinical investigators for clinical trials
• Acts as point of contact for communication and professional relationship with NBI Clinical Investigators
• Conducts assessment and disposition of adverse events (in conjunction with Medical Director if non-physician) and evaluates safety of clinical compounds prior to and during ongoing clinical studies
• Leads effort within clinical development program teams on selection of established and development of novel outcome measures in the context of clinical trials in early and late stages of clinical development
• Leads in the recruitment, training and development of the clinical teams to ensure efficient operation of the function
• Identifies resource requirements, leads budget planning and personnel forecasting for clinical research programs
• Contributes in the scientific writing, including review and - as appropriate - approval of clinical study reports and related documents
• Develops the infrastructure and strategic planning to support advanced clinical trials
• Together with cross-functional team, establishes Implements strategy for regulatory processes with responsibility for all submissions and interactions with the FDA and other regulatory authorities
• Maintains knowledge of ICH-GCP, external regulations and procedures – required for regulatory filing
• Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities
• Collaborates with external opinion leaders. internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes
• Provides periodic status updates and effectively communicate with Senior Management Team
• Responsible for developing the infrastructure and strategic planning to support advanced clinical trials

Requirements

• MS degree in Life Sciences or related field AND 15+ years of related experience in industry with expertise in the areas of drug development, operations and strategic plannings.
• Specialty training appropriate to therapeutic area in addition to experience in clinical drug development (Phase 1-4) in a pharmaceutical/biotechnology company. Prior experience working with CRO is a plus.
• Extensive previous managerial experiences also required OR PharmD or PhD degree preferred AND 13+ years of similar experience noted above.
• OR MD a plus AND 10+ years of similar experience noted above
• 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
• Ability to apply advanced analytical thought and judgment
• Strong leadership, coaching, employee development skills
• Ability to influence others with or without authority at all levels of the organization
• Proactive, innovative, with good problem-solving skills
• Ability to work in a cross functional team and matrix environment
• Experience to effectively lead cross functional teams towards in a goal-directed manner
• Excellent written, presentation, and verbal communication skills
• Extensive knowledge of clinical drug development is mandatory and should include prior experience with clinical development planning, regulatory requirements and documents, study design, biostatistics, monitoring, data handling, data analysis, report writing, and scientific presentation of data

Qualifications

• Must be able to effectively operate in a multi-level matrix corporate environment, requiring interaction with, and/or direction of, internal and external personnel, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel
• Expertise in the areas of drug development, operations and strategic planning
• Expertise in submissions from investigational new drug through new drug application filings and managing a product from pre-clinical through all clinical phases and product launch

Skills

• Expertise in the areas of drug development, operations and strategic planning
• Expertise in submissions from investigational new drug through new drug application filings and managing a product from pre-clinical through all clinical phases and product launch

Benefits

• Annual base salary we reasonably expect to pay is $243,100.00-$331,000.00
• Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills
• In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program
• Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans