Senior Director, Regulatory Affairs

Description:

Pliant Therapeutics is a clinical stage biopharmaceutical company focused on the discovery and development of novel therapies for serious fibrotic diseases.  Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar for progress to meet unmet medical needs for the patients and physicians.  The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules. The Company is seeking a passionate, creative, and dedicated Head of Regulatory Affairs to join our team and contribute to our mission.

Position overview

Pliant is seeking a strong leader in Regulatory Affairs with global experience in the fibrotic and/or rare diseases. This individual will report directly to the Chief Medical Officer and will be part of a dynamic and growing multidisciplinary team focused on the advancement of new drug candidates.  The position will have the responsibility to lead, manage and drive regulatory activities, policy and strategy, to interface with regulatory agencies and corporate partners, and to provide executive management with regulatory metrics and information.

Responsibilities

Support CMO and VP, Clinical Development as follows:
 

• Serve in a Regulatory leadership role to assigned clinical development project teams, providing regulatory guidance and support in global clinical development planning and implementation of regulatory strategy while ensuring compliance with applicable regulation
• Play a key role in planning, preparation, and review of regulatory documentation and ensure data and conclusions are suitable for submission to regulatory agencies
• Work independently, directly and effectively with multifunctional disciplines
  (Preclinical, Clinical, CMC and translational research sciences to accomplish assigned strategic and operational responsibilities related to clinical development
• Coordinate and participate in interactions with regulatory authorities worldwide
• Be a strong and supportive team player. Will be required to mentor, manage and coach staff in technical and leadership areas, demonstrating leadership abilities and professionalism using excellent management skills to establish respect and accomplish goals
• Be proficient in planning, preparation, and review of regulatory documentation and ensure that data and conclusions are suitable for submission to global regulatory agencies
• Manage and interface activities with potential partners and partnered programs
• Responsible for building/hiring and working closely and successfully with an experienced regulatory support staff to ensure orderly and timely completion of project assignments
• Uses extensive knowledge of US, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development programs.   Experience with regulatory authorities in China and Asia-Pacific region desirable

• Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources
• Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of products.
• Champion authoring, cross-functional review and submission of regulatory documents including IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
• Maintains awareness of global regulatory environment and assesses impact of changes on business and product development programs. Facilitates interpretation of global regulation.
• Proactively manages critical issues, taking leadership for the regulatory contribution.
• Develops and implements department policies, processes and SOPs.
• Provides regulatory due diligence assessments of new business opportunities as required

Job Requirements:

• BA/BS Degree required in a health/life sciences or related field. Advanced degree preferred.
• A minimum of 10-15 years in the biotechnology or pharmaceutical industry with at least 5 years of global leadership experience managing a regulatory team. 
• Extensive experience in Regulatory including IND/CTA, NDA/BLA/MAA, lifecycle management, interactions with Health Authorities, and developing and implementing complex regulatory strategies.
• Strong strategic skills including demonstrated ability to make complex decisions and willingness to defend difficult positions.
• Strong business acumen and demonstrated ability to make sound decisions that contribute positively to the business.
• Excellent operational skills including demonstrated ability in planning, organizing and ability to motivate and lead others.
• Ability to create and manage detailed timelines and /or experience with tracking regulatory activities across disciplines and territories

• Strong negotiating skills and ability to think creatively and develop creative solutions
• Strong personal and interpersonal skills, including the ability to relate to and negotiate with others while acting with integrity and credibility to build trust
• Ability to prioritize and handle multiple projects, indications, regulatory divisions simultaneously
• Sense of urgency and perseverance to achieve results
• An ability to interpret statistical and clinical data is essential 
•  Must have demonstrated problem solving abilities 
• An understanding of clinical research, biostatistics, and regulatory affairs is required
• Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that 

• • Fibrotic disease experience is desirable.
  • Business travel to be ~10-20% as required.

Leadership Skills
 

• • Set & Achieve Goals: Understand business objectives and effectively translate them into strategies, while skillfully navigating obstacles and resistance to change.
  • Inspire & Mobilize Others: Serve as a positive role model – create followership and effectively mobilize and influence others, both on your team and across the organization.
  • Provide Ongoing Coaching & Feedback: Coach others to achieve their goals through encouragement and high-quality feedback, and support the growth and development of team members.