Clinical Trials Disclosure Assoc Director

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the worlds toughest diseases, and make peoples lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond whats known today.

• Head of Clinical Transparency & Disclosure for Amgen India. This role will manage and have operational oversight of AIN CTD staff
• Develop and retain a high performing team and foster a culture aligned with Amgen values
• Design, develop and implement streamlined policies, methods and processes for generation of redacted and anonymized regulatory documents
• Build strong relationships and provides expert guidance to key internal partners, synthesizing knowledge of global requirements with corporate strategies and business plans.
• Oversee training for organization and foster best practices, contingency planning and risk mitigation
• Drive compliance to applicable regulations, laws and policies. Support business process owner, including responding to internal and external audits and inspections and any associated CAPAs
• Lead development and maintenance of key metrics and address deviations.
• Lead/ participate in departmental and cross-departmental initiatives as appropriate

• Doctorate degree and 3 years of directly related experience OR
• Masters degree and 10 to 14 years of directly related experience OR
• Bachelors degree and 14 to 16 years of directly related experience OR
• Diploma and 18 to 20 years of directly related experience

Basic Qualifications:

• Expertise with regulatory document public disclosure, including anonymization and protection of commercially confidential information
• Strong communication skills including excellent spoken and written English
• Advanced knowledge of clinical trial disclosure regulations and policies
• Extensive experience developing policies, plans and processes that keep abreast of constantly changing environment
• Ability to interpret complex requirements and translate these into robust, compliant and efficient business processes
• Ability to effectively operate in an environment which requires negotiation, persuasion, collaboration, and perseverance with a drive to results
• Navigates ambiguity
• Experience with mentoring, training and directing others
• Strong time, project management and decision-making skills including prioritization
• Experience leading change management

Preferred Qualifications:

• Industry experience: 9+ years experience in life sciences or medically related fields including 6 years in a biopharmaceutical clinical development, regulatory affairs or clinical writing management
• Previous people management experience