Regulatory Life Sciences Associate Director

Posted:
7/14/2024, 5:00:00 PM

Location(s):
Virginia, United States ⋅ McLean, Virginia, United States

Experience Level(s):
Senior

Field(s):
Business & Strategy ⋅ Legal & Compliance

Job Family:

Strategy & Transformation Consulting


Travel Required:

Up to 10%


Clearance Required:

Ability to Obtain Public Trust

What You Will Do:
 

Is life sciences in your DNA?  Breakthroughs in pharma are helping people live longer, healthier lives while bringing hope to patients with rare diseases. With outpaced growth across the industry and advancements in drug development this is undoubtedly a transformative time for regulators, developers, and patients. Guidehouse’s Regulatory Life Sciences practice is an engine of innovation helping pharmaceutical, biotech, medical device, and diagnostic regulators tackle today’s challenges, while anticipating tomorrow’s. You will have an immediate impact by partnering with senior leaders in government to tackle the barriers and opportunities to accelerate innovation, drug approvals, and more. Your work will directly impact how fast lifesaving drugs and therapeutics become available to patients with no known treatment today. Are you up for the challenge? 

As an Associate Director within the Guidehouse Public Health practice, you will lead a team of experts and consultants across biologics, medicine, digital health, analytics, and strategy on some of the most pressing public health priorities in our nation. You will grow client relationships with senior leaders to build trust, deliver customized solutions, and grow our business. As your teams deliver you will coach and mentor them, delivering feedback and support to elevate delivery for our clients. You will lead and facilitate strategy and problem-solving sessions with clients and their stakeholders, including industry, trade association, and patient group leaders. You will be expected to prepare strategic and operational client-ready materials to facilitate decision-making and execution for the client. You will lead proposal efforts for clients and be expected to contribute to the growth of our existing portfolio. We are looking for someone who brings industry and/or regulatory knowledge, strategic planning experience, and a passion for developing high-performing teams.

We continuously strive to foster an inclusive and diverse work culture and thoughtfully develop our people through challenging work, valuable learning and educational programs. We cultivate a culture of mentorship and feedback for professional and personal growth.    We help our clients take control of their future. This mission extends to our employee's careers, health and well-being and by the many ways we give back to our communities. If you’re passionately motivated to make a difference and deliver exceptional work, we invite you to learn more about your career opportunities at https://guidehouse.com/careers

What You Will Need:

  • Bachelor’s degree from an accredited college or university
  • 7+ years of relevant industry or consulting experience, excluding internships, co-ops, fellowships and academic research
  • 3+ years of experience supporting public health-focused federal agencies or 3+ years experience with pharma or bio tech regulatory functions in a management capacity
  • Demonstrated experience leading strategy, process improvement, and change management projects
  • Demonstrated experience leading teams (at least 10 full time resources at a given time)
  • Demonstrated ability to establish and maintain strong business relationships with senior executive clients
  • Outstanding analytical and problem-solving skills
  • Strong organizational and management skills
  • Excellent written and verbal communication skills with a demonstrated ability to make difficult concepts easy to understand
  • Demonstrated ability to both collaborate as a part of team and work independently
  • Ability to manage several tasks simultaneously, prioritize and plan work activities while meeting respective deadlines.
  • This position is open to Washington, DC area based candidates or those who are willing to relocate there.  


What Would Be Nice To Have:

  • Master's degree in a relevant discipline
  • Experience working with the US Food and Drug Administration (FDA) or related Department of Health and Human Services (HHS) operating division in the past 12 months
  • Relevant professional certification(s) (e.g., Project Management Professional - PMP, Lean Six Sigma Green Belt, Certified Change Management Professional - CCMP)
  • Existing strong relationships with FDA and other HHS leaders
  • Track record of managing a team's performance to achieve organizational goals and exceed client expectations.
  • Experience working and collaborating with other leaders to pursue add-on and cross business opportunities with current and prospective clients.


What We Offer:

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:

  • Medical, Rx, Dental & Vision Insurance

  • Personal and Family Sick Time & Company Paid Holidays

  • Position may be eligible for a discretionary variable incentive bonus

  • Parental Leave and Adoption Assistance

  • 401(k) Retirement Plan

  • Basic Life & Supplemental Life

  • Health Savings Account, Dental/Vision & Dependent Care Flexible Spending Accounts

  • Short-Term & Long-Term Disability

  • Student Loan PayDown

  • Tuition Reimbursement, Personal Development & Learning Opportunities

  • Skills Development & Certifications

  • Employee Referral Program

  • Corporate Sponsored Events & Community Outreach

  • Emergency Back-Up Childcare Program

  • Mobility Stipend

About Guidehouse
Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.


Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.


If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at [email protected]. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.


Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.