Clinical Trials Disclosure Assoc Director

ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s 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 what’s known today.
 
What you will do 

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

  
 
What we expect of you 

Doctorate degree and 3 years of directly related experience OR

Master’s degree and 10 to 14 years of directly related experience OR

Bachelor’s 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

EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.