Employment Opportunities:

Director, Clinical Affairs - Bannockburn location

The Director or Senior Director, Clinical Affairs is a tactical and leadership position that reports to the Vice President of Clinical and Regulatory Affairs and is responsible for devising, implementing and managing the clinical operations of multiple pharmaceutical products over all phases of development.  The position responsibilities also include appropriate allocation of resources, management of and adherence to project costs and timelines, and mentoring and motivating departmental and cross-functional employees.  The ideal candidate would be detail-oriented with good organizational, time management and leadership skills, and would have familiarity with the conduct of clinical research in a regulated environment.

Key Responsibilities:

• Contribute in proactively formulating global clinical development strategies that successfully execute Cytochroma’s core business of pharmaceutical development.
• Prepare clinical development timelines and budgets within multidisciplinary project teams to ensure timely submissions aligned with Cytochroma objectives.
• Coordinate, facilitate and construct study designs and protocols, appropriate study monitoring and conduct within cGCPs and consistent with the requirements for regulatory filings
• Develop, interact with, and manage internal employees and external CROs and CMOs to assure timely and cGCP compliant activities to achieve clinical project successes to achieve corporate development plans
• Participate in regulatory submission process, including INDs, CTAs, CTDs, NDAs and provide appropriate clinical updates to those documents
• Ensure that all documents to be submitted to regulatory agencies are complete, scientifically accurate, well-organized and of high quality in such a way as to facilitate review
• Serve as the principal spokesperson for clinical development and communicate to senior management of clinical development status
• Build and maintain good business and working relationships with internal and external groups
• Participate in the selection and maintenance of study investigators and clinical sites
• Participate in analysis and review of data, and review, edit and contribute to the construction of clinical documents (study protocols and reports, informed consent and case report forms, publications) to ensure cGCP compliance and accurate presentation of data
• Communicate openly and effectively, working to develop team-based approach and to lead and to motivate regulatory and compliance activities
• Assist senior management to formulate and to establish company policies and operating procedures (SOPs) and ensure that staff attains a level of quality applicable to the Quality System and applicable professional standards
• Coordinate and implement the requisite training and development of Clinical Development staff
• Provide strategic leadership to identify potential difficulties and strategic execution to implement creative approaches to surmount challenges
• Participate in activities related to potential in-licensing and out- licensing of products

Requirements:

• BSc in biological or chemical sciences; advanced degree is preferred
• 5-10 years pharmaceutical industry clinical development experience including support of product approvals and renewals and post marketing activities, interacting with principle investigators and key opinion leaders
• In-depth experience with clinical trial methodology, cGCPs per FDA and ICH guidelines, strategic clinical trial planning and operation, and comprehensive planning and management of project budgets
• At least 2 years people and project management experience with strong interpersonal skills and proficiency in verbal and presentation capabilities
• Ability to work independently and as a functional leader and participant in teams
• Knowledge of biostatistics and data management would be a plus
• Approximately 20% travel within the United States and International

To apply for this opportunity, please submit your resume in confidence to hr@cytochroma.com. Please ensure that you quote the job title in your email.

We thank all applicants for their interest; however, only candidates under consideration will be contacted. No phone calls please.