Managing Director, Risk & Program Management Quality and Operations Lead

Updated: September 20, 2021
Location: Morrisville, NC, United States
Job ID: 135441


Not ready to apply?
Join our Talent Network

Overview

You’re driven, resourceful, and above all else - remarkably smart.

You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

Responsibilities

You’ll join The Risk And Program Management Group within Syneos Health Consulting. You will assist pharma consortiums in facilitating the myriad legal, financial, and operational risks and nuances of program management. 

More specifically: 

The Managing Director is the leader of the REMS Operations Office. They are an experienced leader in the REMS industry, with significant knowledge regarding REMS strategy, operations, and inspections. The Managing Director is viewed as a key senior leader within the Commercial business, drives meaningful cross-functional success to expand the REMS Integrated Solution business. In this role, the Managing director collaborates with Commercial leadership to define REMS strategies, operating models, and priorities, and provides recommendations to drive REMS growth within the Commercial business

Experienced thought leader in the biopharmaceutical industry, a trusted advisor to clients, and viewed as a key senior leader within the Consulting business with accountability for program management, team leadership, and business development. As part of the Consulting leadership team, Managing Directors contribute to setting business direction, strategy, and priorities and take ownership for driving the overall growth and scalability of the Consulting business.

REMS Operations Office  
  • Leads the cross-functional REMS Operations Office (ROO), develops, implements, and maintains the ROO charter
  • Works closely with appointed REMS Project Leads and REMS Project Managers, and their line mangers, to maintain effective cross-functional operations
  • Operating chair for the REMS Oversight Committee and REMS Strategy Committee
  • Provides timely insights to the RPM Advisory Group Leader regarding ROO activities
  • Drives broad organizational understanding regarding ROO and REMS Integrated Solution (RIS) capabilities
  • Defines and develops ROO structure, builds team, seeks to find and nurture talent, maintains succession plans
  • Provides performance coaching and career development for ROO team - gathers project performance reviews, conducts annual reviews, and contributes meaningful feedback to promotion calibration sessions
  • Performs as a highly respected & visible leader, displays the passion and drive of a business owner, and viewed as a positive role model for teams

 REMS Integrated Solution

  • Oversees the implementation of the RIS quality program, and provides periodic updates to leadership
  • Key contributor to all RIS audits and inspection activities, and accountable for ensuring all CAPAs are implemented as necessary
  • Provide RIS strategic planning recommendations to expand service features and maximize client satisfaction
  • Provides subject matter expertise to REMS Program Leads and REMS Project Managers as they design, implement and maintain their REMS projects

 REMS Industry

  • Builds significant relationships across the brand and generic pharmaceutical industry, to develop future project opportunities
  • Monitor all relevant legislation, regulations, guidance, and best practices affecting RIS services.  Recommend changes to existing RIS operations and controlled documents accordingly.
  • Demonstrates significant specialized subject matter expertise & thought leadership, identifies industry trends and incorporates into REMS services
  • Maintains a broad awareness of relevant Health IT topics, and participates in external REMS communities, industry groups etc.

 Productivity

  • Builds positive working relationships with clients, consulting staff, managers, leadership, and internal support teams.
  • Achieves commercial success by harvesting accounts and creating leads at new accounts, helps other MDs to close deals, and securing profitable business.
  • Supports the development of a growing and healthy Advisory Group and overall Consulting business unit.

 Delivery

  • Skilled at assessing REMS Program needs and designing value-add solutions.  Acts as a subject matter expert for REMS Program teams and contributions are valued as critical to the success of the programs.  Recognized strategic mindset, with the ability to analyze, distill, and communicate for senior-level audiences.
  • Proficient at reviewing materials and content for relevance, accuracy, and strategic direction.  Provides regular feedback on team members’ strengths and areas for development. 
  • Proven leadership across and management of multiple projects.  Ability to multi-task, manage ambiguity, and collaborate internally and externally.
  • Establishes specialized subject matter expertise and thought leadership.  Identifies industry trends and incorporates into REMS programs.  Demonstrates thought leadership and uses it to build innovative offerings and to enhance current market offerings.  Creates market eminence and is an influential leader internally and externally.  Shares domain knowledge and case studies with the broader Consulting team.
  • Utilizes available staff and manager resources and develops them in a manner that enables target attainment and efficient project execution/scalability.  Creates a culture of mentorship, collaboration, and retention within program teams and the Advisory Group, more broadly. 
  • Exhibits professional, positive, respectful, and mature interactions internally & externally.  Displays passion and drive while advocating for a superior client experience through program leadership.

 Community

  • Well-respected and visible leader within the company.  Viewed as positive role model for teams and enjoyable to work for / with.  Displays the passion and drive of a business owner.
  • Actively builds relationships with leaders across Consulting Advisory Groups and other businesses within Syneos Health.
  • Takes responsibility for career advising to consulting staff team members as a Development Coach.  Gathers project performance feedback, conducts performance reviews, and contributes meaningful feedback to internal promotion calibration sessions.
  • Focused on team development and seeks growth opportunities for team members.
  • Actively takes a leadership role in company-sponsored events, training and professional development opportunities, meetings, and office and Advisory Group initiatives. 
  • Involved in internal recruitment, training, and retention initiatives.
  • Drives a positive, collaborative, and professional team culture through words, attitude, and actions.
  • Understands personal strengths and development needs.  Seeks feedback and coaching.  Sets annual professional development goals and engages in appropriate developmental stretch opportunities.
  • Actively builds professional networks through social media, seminar/conference attendance, and lead/referral generation.
  • Proactively seeks opportunities to expand knowledge of the biopharmaceutical industry, Consulting service offerings, and client products and markets.  Expert in REMS requirements, and related service offerings and functional areas.
  • Demonstrates Syneos Health core values in action and word and holds other team members accountable to company values, as well: challenge the status quo, collaborate to deliver solutions, and passionate to change lives.

Job Requirements

Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:

  • Advanced degree in a science/health care field
  • 15+ years of experience working in the pharmaceutical, life science or consulting industries, with at least 5 years senior leadership experience working in GxP organizations
  • Significant experience working with REMS programs, strong knowledge of the relevant REMS legislative and FDA guidance environment, and GvP quality systems
  • Direct experience interfacing with FDA Division of Risk Management and FDA inspectors
  • Skilled in directing the work of others and driving results
  • Displays a strategic mindset and seeks innovative solutions
  • Aptitude for translating ambiguity and uncertainty into actionable next steps through resourcefulness, resiliency, and adaptability
  • Critical thinking and problem solving skills
  • Exceptional interpersonal and collaboration skills
  • Ability to assess client needs and deliver high-quality, effective communications
  • Known authority in the market; able to leverage external network to improve profitable revenues and market positioning
  • Strong and demonstrable track record of successful practice building
  • Talent for growing and developing key client and internal relationships
  • Demonstrated competency in building high performing, customer-focused teams

As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.

At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality of life balance.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Here, you’re a part of the big picture. We work hand in hand to guide pre-market development through post-market commercial strategy. Knowledge sharing across advisory groups unlocks the innovation and unique strategies our end-to-end commercialization projects require. Our collaborative mindset means every project is a chance to solve a new challenge, learn from your teammates, become better-rounded, and evolve your career.

WORK HERE MATTERS EVERYWHERE | How will you accelerate biopharmaceutical commercialization?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

 


Not ready to apply?
Join our Talent Network

Click here to enable personalized experience

 

Inside Syneos Health

Tell Us About Your Candidate Experience! Get In Touch