VP, Associate General Counsel, Compliance

Posted 9 Days Ago
Be an Early Applicant
Hiring Remotely in US
Remote
340K-400K
Senior level
Biotech
The Role
The VP, Associate General Counsel, Compliance oversees compliance matters, develops programs, partners with leadership, and mitigates risks related to healthcare compliance in pharmaceutical contexts.
Summary Generated by Built In

Prothena’s success is driven by our people. We are dedicated to attracting individuals who share our vision to improve human health by putting patients first.

But it’s not just about what we do at Prothena, it’s how we do it. That’s why we hire creative and courageous individuals who support one another and are not afraid to try new ideas. Our culture reflects our values which are brought to life every day by the following characteristics:

SELFLESS - Patients come first and we’re in this together. Our environment is collaborative and we measure success through our collective accomplishments.

COURAGEOUS - Transformational innovation leads to novel treatments. “Tried-and-true” won’t produce breakthroughs for patients – a pioneering spirit, willingness to accept certain risks and to try new approaches. Each Prothenian and functional team is expected to bring their heart, experience and trust on our journey.

IMAGINATIVE - We value and encourage a creative approach across all aspects of our work. We challenge ourselves and each other to think beyond what is known and approach our work through a lens of continuous improvement.

JOYFUL - Humor and heart allow us to tackle the seriousness of our work. Excellence and fun are not at odds – we love what we do and enjoy the journey.

Position Overview:

Reporting to the Chief Legal Officer, the VP, Associate General Counsel, Compliance, will serve as the senior legal advisor on compliance matters related to product development; sales, marketing and promotion; medical education and medical affairs activities; patient access programs; government price calculation and reporting; privacy and data management; and all other aspects of compliance with pre-commercial and commercial activities. The position will also play a key role in risk evaluation, management, and mitigation activities.

Responsibilities:

  • Develop and oversee the company’s healthcare compliance program, including policies, training, and monitoring/auditing activities, to achieve effective internal controls and oversight in the United States, Europe, and other territories
  • Partner with cross-functional company leadership to develop, implement, and maintain policies and systems that prevent violations of law, regulations, and company policies, while enabling operational excellence
  • Serve as an independent voice and source of information on matters of compliance for the company’s CEO and Board of Directors
  • Structure and scale the future growth of the compliance group to match the company’s growth and needs
  • Establish relationships and serve as a strategic business partner to cross-functional leads and senior management to drive a culture of compliance across the Company

Requirements:

Education and Experience:

  • J.D. from an accredited law school
  • Admission to a state bar and active license to practice required
  • 10-15 years of legal experience – whether law firm or in-house – with at least 5 years of experience as a healthcare compliance professional at a pharmaceutical or biotechnology company supporting marketed products preferred
  • Experience building, implementing, and continuously improving a compliance function
  • Experience developing and implementing strategic initiatives that align with business goals within established budgets and timelines
  • Expertise in FDA advertising and promotions requlations, False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless, and joyful
  • Ability to understand the science behind the company’s product candidates and the product development process
  • Excellent verbal and written communication skills, including interpersonal skills

Compensation Overview:

The anticipated annual salary range for this role as the VP, Associate General Counsel, Compliance job level is $340,000 to $400,000.  This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting.  We may ultimately pay more or less than the posted range, and the range may be modified in the future.  The final salary offered to a successful candidate will be dependent on several factors that may include – but are not limited to – the final job level offered, the type and length of experience within the job and industry, relevant education, qualifications, skills, certifications, performance, and business or organizational needs.

The hired applicant will be eligible to receive an annual bonus and an equity grant in the form of stock options.

Health & Wellness Benefits, 401(k) and PTO Overview:

  • All Prothena employees (and their families) are covered by medical, dental, and vision insurance, with Prothena paying ~90% of plan premiums. 
  • Prothena pays the full premium for basic life and disability insurance for all employees.  
  • Prothena employees are also eligible to enroll in our Company’s 401(k) plan and are always 100% vested in their account balances.  The 401(k) plan provides for a quarterly, non-discretionary, 3% company-paid contribution on eligible earnings, as well as an additional, annual discretionary Company match of up to 2% of eligible earnings.  
  • New Prothena employees are also eligible for 17 days of paid vacation accrued over the course of the first year of employment, paid sick time in accordance with state law, and company-paid holidays – which includes a Company-wide shutdown at the winter holidays.

More information about Prothena can be found at the Company’s website: www.prothena.com.

Top Skills

Compliance Programs
Fda Regulations
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The Company
HQ: Grand Canal Docklands, Dublin
166 Employees
On-site Workplace
Year Founded: 2012

What We Do

Prothena is a late-stage clinical biotechnology company with expertise in protein dysregulation and a diverse pipeline of novel investigational therapies for neurodegenerative and rare peripheral amyloid diseases.

We are committed to developing novel and transformative medicines to create a better future for people in critical need of new treatment options. Our product portfolio is designed to make a significant impact on neurodegenerative and rare peripheral amyloid diseases, which affect millions of people and their families worldwide.

We leverage insights around neurological dysfunction and the biology of misfolded proteins to develop novel therapeutic solutions that directly target pathogenic proteins in order to change the course of devastating diseases.

At Prothena, our success is driven by our people. We are dedicated to attracting individuals who share our vision to improve human health by putting patients first. Our shared humanity drives a passionate and unwavering commitment to apply high scientific rigor toward developing innovative new therapies for patients. We have ambitious goals and take every aspect of our mission seriously, while enjoying the journey. Our values connect us – you will see and feel them come to life in all we do – together

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