Vice President, Corporate Compliance

Categories: Legal
POSITION SUMMARY:
 
The Vice President of Corporate Compliance is responsible for providing strategic leadership and develop operational ways to uphold the legal, regulatory, and ethical obligations of a pharmaceutical company. This leader will have direct oversight for the design, development, implementation and management of Crinetics’ compliance program and associated systems. The Vice President of Corporate Compliance will provide a broad range of compliance support throughout Crinetics’ organization partnering with the multiple leaders and different departments to sustain Crinetics’ ethical and compliant culture.
 
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
 
These may include but are not limited to:
 
  • Independently lead the development, implementation, and management of the compliance program, including policy and  process development, establishing an effective training program, communication of compliance issues as well as  auditing, monitoring, and investigations.
  • Responsible for the development and oversight of the company’s compliance auditing, monitoring and investigation process, including:
  • Assessing organizational compliance risk in creating and updating a risk-based audit and monitoring plan. Partnering with the business to address detected noncompliance including recommending and taking corrective actions when needed.
  • Track and report results of compliance investigations and the corrective actions taken to Compliance leadership and other internal key stakeholders as needed. Interpret findings/trends and carry out corrective action and retraining as needed.
  • Develop, manage, and oversee compliance policies, programs and develop a comprehensive compliance training program and communication strategy to employees and designated third parties on applicable compliance policies, laws, and regulations, including any new developments or updates that may impact the Crinetics’ compliance program.
  • Key ambassador for communication around key compliance topics, resources, and special initiatives.
  • Provides leadership and guidance on compliance across business programs.
  • Monitor the business developments and industry compliance best practices to evolve the compliance program through ensuring appropriate practices, processes, systems, and tools are in place and maintained to always support the business.
  • Provides legal expertise regarding regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG and OPDP guidance the PhRMA Code, the Sunshine Act, Foreign Corrupt Practices Act and competition law in connection with product labeling, promotional and promotional activities, marketing strategies, sales compensation, government reimbursement, and interactions with healthcare professionals.
  • Other duties as assigned.
 
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
 
  • Bachelor’s degree, (Advanced degrees such as master’s degree or Juris Doctor preferred) or related discipline with at least 15 years of compliance related experience (An equivalent combination of experience and education may be considered).
  • Minimum of 12 years of experience managing and developing compliance related functions/teams.
  • Demonstrated ability to create and implement a vision, strategy, and plan for compliance at a biotech/pharmaceutical company.
  • Certification of Healthcare Compliance (CHC) and Certified Compliance and Ethics Professional (CCEP) preferred.
  • Working knowledge and previous experience in a compliance operations position.
  • Ability to effectively collaborate with the Executive Leadership Team to define compliance’s role in supporting the business and ensuring adherence.
  • Positive, forward-looking leadership style, displaying personal courage while remaining flexible and sensitive to different circumstances.
  • High emotional intelligence, with the ability to solve problems, coach others, and take decisive action to rectify any issues.
  • Strong communication (written and oral), presentation, and interpersonal skills with an ability to effectively function within a matrixed environment.
  • Ability to communicate complex compliance concepts to executive management and others in the organization in a way that is connected to business objectives.
  • A highly organized and self-directed approach to work, including the ability to handle multiple projects simultaneously and prioritize competing tasks in time-constrained situations.
  • Impeccable attention to detail.
  • Excellent influence skills and ability to influence senior executives as well as more junior team members.
  • A consultative, collaborative, client-focused, and team-orientated leadership style.
 
TECHNICAL KNOWLEDGE REQUIRED:
 
Equipment:  PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained. 
 
Software Knowledge:  Windows, MS Office (Outlook, Word, Excel, PowerPoint), Prism or equivalent statistical and graphing software.
 
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
 
Physical Activities:  On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required.  The noise level in the work environment is usually low to moderate.  The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
 
TRAVEL:
 
Travel may be required up to 20% of your time.
 
ABOUT CRINETICS:
 
Crinetics Pharmaceuticals Inc. (www.crinetics.com) is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. Crinetics’ benefit package includes health insurance, stock options, ESPP, a 401k, paid time off, and the company provides a dog-friendly work environment. Crinetics is an EEO/AA/Disability/Vets employer.​