The Senior Director, Clinical Development will represent Clinical Development in assigned Core Development Teams and will be responsible for providing clinical input, drug development strategy and ensuring consistency of processes in relation to clinical trial management, training and audit activities. This person will be accountable for the consistent and efficient approach of all aspects of clinical trial management for clinical trials sponsored by Noven Pharmaceuticals.  This individual will also be responsible for understanding global regulations in conjunction with the regulatory affairs group and reviewing impact of such regulations on Noven sponsored clinical trials.

• Represent Clinical Development in assigned Core Development Team and provide clinical input to clinical development strategy.
• Provide direct oversight of Noven’s clinical development programs including project planning, budgets, timelines, and risk management to complete clinical studies on-time and within budget to meet company goals.  
• Responsible for managing all clinical research activities for Phase I – IV clinical trials, conducted in the US and globally, including protocol writing, study execution, data review, statistical analysis and clinical study report writing and publishing.  
• Continuous evaluation of clinical trial processes to identify and address strengths and weaknesses to maintain a competitive advantage.
• Administrative leadership for all clinical activities of assigned clinical trials/programs.
• Work effectively with other internal disciplines to execute clinical trials by implementing best practices and strict adherence to GCP requirements.
• Identify resourcing needs for assigned projects, including internal and external outsourced services (i.e., CROs, laboratories, contractors, in-house staff, etc.); participate in the request for proposal process including defining expectations and deliverables; assess quality, qualifications and experience of vendors; participate in negotiating contracts and budgets for vendors; participate in the selection and cost effective management of vendors.
• Collaborate extensively with other units outside of Clinical Development to obtain functional input on all activities related to development of initiatives, processes, tools, and systems.
• Maintain knowledge of US and foreign regulations, guidelines, policies and practices for conducting global clinical trials. Review changes to US and global regulations with regulatory affairs to determine impact on current or future trials.
• Mentor Associate Directors, Clinical Project Managers and other job roles related to Clinical Development to expand employee performance levels and assure retention of high performing associates.
• Provide strategic direction in assessing relevant new technologies and champion new tools for process improvements, e.g., electronic trial master files (eTMF), clinical trial management systems (CTMS).
• Author and/or review clinical protocols and provide oversight for trial implementation activities.
• Ensure timely development of study documents such as informed consent form, case report forms (CRFs), CRF guidelines, statistical/ pharmacokinetic analysis plans, monitoring plan, data management plans including edit check specifications, clinical study report (CSR), etc.
• Assess study drug requirements and shipment logistics; contribute to labeling strategy.
• Define site qualification criteria and oversee the identification of potential investigators and clinical sites and participate in the final selection of study sites.
• Review site contracts, site regulatory documents, Institutional Review Board (IRB) approvals, IRB questions, informed consent and other relevant documents, in conjunction with relevant internal departments.
• Responsible for all performance metrics and quality of deliverables in a clinical trial; monitor clinical trial progress; develop Program/Study/Investigator Budgets, and perform ongoing analysis related to study progress and/or work being performed by vendors; assess adequacy and comprehensiveness of study / program tracking systems.
• Oversee and participate in Investigator Meetings; oversee day-to-day activities of the clinical trial and associated resources (CROs, CRAs, centralized laboratories, etc.).
• Identify and evaluate issues related to the project and coordinate resolutions; Identify data deficiencies and discrepancies, and coordinate corrective action as required.
• Continuously evaluate compliance to applicable SOPs and quality of site monitoring and associated documentation; develop corrective action plan if indicated.
• Assist in the site audit process and coordinate the audit responses to ensure compliance to industry and company standards.

Competencies:

Ability to anticipate issues and take initiative to resolve them in a timely manner; Strong work ethic with perseverance to achieve results; Ability to break down complex problems into lists of actionable items ; Keen understanding how the project manager interacts with others’ roles to most effectively advance trial objectives; Excellent communication, writing and presentation skills; Ability to lead and organize team meetings; Ability to foster effective relationships with vendors, investigators and colleagues.

Education / Experience:

Ph.D., Pharm.D or M.D. in related field or equivalent.  10+ years of relevant industry experience (sponsor or CRO); Must have cross-functional clinical project management experience; Comprehensive understanding of pharmaceutical regulatory requirements and impact on clinical trial operations; Excellent strategic skills with the ability to influence decisions at a senior level, both internally and externally, and to communicate complex clinical issues in a scientifically sound and understandable way; Experience with a broad range of clinical trials (Phase I-IV) both in the U.S. and ex-U.S; Experience with clinical operations infrastructure including writing of SOPs, developing and  implementing development tools; In-depth understanding of industry standards including ICH guidelines, GCPs, compliance, and the CFR; Understand the roles/responsibilities and inter-dependencies for key functions involved in clinical development.

Judgment / Decision Making:

Establishes and implements strategies with direct impact on departmental / functional results.  Develops and implements initiatives, processes and goals for departmental / functional area within overall area of responsibility. Recommends policies, methods, processes, techniques for the business function based on change initiatives; creates / conceptualizes new methods, techniques, and /or processes across job areas or functions.

Work Environment:

Majority of time spent in office environment, operating computer.

Physical Demands:         

Visual acuity and manual dexterity required to operate computer and proofread documents.