Sunovion Executive Director, Clinical Research - Psychiatry in Marlborough, Massachusetts
Sunovion Pharmaceuticals is looking for an Executive Director, Clinical Research – Psychiatry to join our R&D Organization in Marlborough, MA or Fort Lee, NJ.
This individual will lead strategies for assigned clinical drug development programs through regulatory approval, as well as post approval commitment/life cycle management, ensuring timely execution of team deliverables to achieve business critical milestones.
Senior member of Clinical Research function responsible for designing and oversight of strategically focused clinical development plans and budgets. Oversee the execution of these plans in a high-quality manner, on time and within budget.
Leads multidisciplinary team(s) for assigned asset(s) while managing across a matrixed organization.
Collaborating with Clinical Operations, oversees operationalizing clinical studies, including country/site selection, vendor evaluation, and digital technology evaluation.
Oversees the monitoring of safety and efficacy of trials to ensure integrity of data and GCP Compliance.
Provides oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors as required. Works with the safety group to ensure adequacy of safety monitoring and reporting.
Leads strategy discussions and contributes to decisions regarding content for Health Authority interactions (includes FDA, EMA, PMDA), presents at regulatory meetings as required, and responds to Health Authority queries.
Oversees the timely and accurate preparation of clinical study protocols, study reports, clinical portions of Investigator Brochures, safety reports and other regulatory submission documents.
Manages project budgets, internal resources, external partners, consultants, and vendors to ensure timely and cost-effective implementation of the clinical development plans.
Analyzes and presents data from clinical trials to internal and external audiences in a timely manner, including senior management, advisory boards and scientific/medical meetings. Participates in the creation of publication plans and manuscripts.
Participates in in-licensing evaluations and due diligence efforts. Represents Clinical Research on various internal committees as assigned by the Head of Global Clinical Research, CNS.
Minimum Education, Experience, Knowledge and Skills Required:
MD, DO or equivalent international medical degree is required, preferably with clinical training and board certification in Psychiatry.
7+ years of pharmaceutical industry experience in Clinical Research.
Extensive knowledge of clinical development principles, pharmaceutical industry practices and standards, and deep understanding of current GCP and other relevant regulations/safety monitoring. Knowledge of psychiatry space, current literature, relationships with psychiatry KOLs a plus.
Demonstrated ability to set clear priorities, lead, influence and build consensus in a multi-disciplined team environment. Strong leadership skills and ability to motivate large, multi-functional teams. Strong collaborative teamwork skills.
Fast-paced environment requires handling multiple demands. Must be able to exercise appropriate judgment, as necessary. Requires a high level of initiative and independence.
Strong oral and written communication skills with the ability to communicate effectively at all levels of the organization and with external stakeholders.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Lead the way to a healthier world by putting patients at the center of everything we do
We are focused on developing innovative therapies and transforming the lives of people with serious medical conditions. We are creating innovative psychiatric, neurological and respiratory therapies that help transform people's lives, while at the same time we are playing an increasingly active role in the future of global health.
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer. Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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