Primary Responsibilities and Duties:
The Senior Director Clinical Science will play a key role in strategy development, leadership, design and reporting of ongoing and new development programs. He/she will successfully lead one or more clinical teams to deliver high quality clinical studies and regulatory dossiers. The position requires the ability to partner with Clinical Operations, PMO, Safety/Pharmacovigilance, Regulatory, Early Development, Medical Affairs, and other stakeholders. The successful candidate will have direct and recent experience with US and EU regulatory interactions for late phase development, and in KOL interactions, management and development of direct reports and matrix projects.
- Provide therapy area medical and scientific expertise to Clinical Development and other stakeholders to understand emerging medical discoveries and trends, and anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and integrate factors into planning
- Demonstrate leadership for the Clinical Sciences team by effectively communicating the strategic vision, the operational plan needed to achieve the vision
- Work with partners to assure that lifecycle management and strategic positioning are in line with company goals and regulatory requirements
- In conjunction with Clinical Operations, lead the execution of a global clinical development program in the US and EU, providing on-site leadership and guidance for the clinical science team
- In partnership with Biometrics and other stakeholders, lead analysis and reporting of assigned projects. Provide medical and scientific expertise in evaluation and presentation of data and trial
- results, including advanced skills with relevant software such as Microsoft Excel and PowerPoint
- In partnership with Regulatory, Medical Writing and Project Management, oversee and ensure the production, quality, and timeliness of clinical sections of IND's, Investigator Brochures, CTA's, ISS', ISE's and clinical expert reports, including writing and editing
- In conjunction with Medical Writing and Publication Committee, prepare abstracts, manuscripts and presentations for external meetings
- In conjunction with Finance and Clinical Operations, effectively manage budget and resources, funding and expenses for Development projects
- Possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business
- Attract and develop talent, coach and mentor others to higher levels of performance
- Create an atmosphere of innovation and continual improvement
Minimum Education Required:
Doctoral level degree (MD, PhD, PharmD, PsyD)
8+ years clinical development experience including product registration in the U.S., Europe. Experience in CNS development (Psychiatry or neurology) preferred
- Proven track record of successful leadership of clinical development project teams
- Possess extensive knowledge of the late stage clinical development and registration process for small molecules. Knowledge of large molecule development, biologics and gene therapy a plus
- Experience building strong relationships within the group (Regulatory, Product Development) and across functional groups (Medical Affairs, Commercial) to achieve results
- Proven track record of success of directly leading, managing & developing talent; Build teams by understanding the skills and capabilities needed to effectively meet goals and objections and align them with the talents and capabilities of team members.
- Excellent writing and communication skills, experienced in presentations (internal and external) and regulatory writing (IND, CTD sections)
- Ability to make significant decisions and recommendations and persuasively present data and support materials to gain approval and sponsorship for projects from senior management.
- Skilled at presenting opinions and recommendations persuasively and authoritatively utilizing compelling information, strong influencing skills, personal credibility and strength of one's convictions and commitment.
- Ability to handle obstacles and roadblocks by anticipating challenges and preparing well thought out arguments and contingencies.
- Proven track record of garnering support for projects and recommendations through on-going collaboration, open and influential communications and commitment to improvement/change.
- Ability to travel as required, including international travel. Average 10-20%, reaching 50% or more in some months.
- Experience in product launch and internal safety review a plus