Senior Director, Regulatory Affairs

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.

 

Senior Clinical Research Associate

Senior Clinical Research Associate

Department:

Clinical Operations

Description: 

Pliant Therapeutics is a clinical stage biopharmaceutical company focused on the discovery and development of novel therapies for 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 patients and physicians. The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules.

Position Overview: 

The Senior Clinical Research Associate (Sr. CRA) is responsible for assisting the Clinical Trial Manager in managing and/or leading the day-to-day operations of assigned study execution tasks to ensure completion per established project team goals and objectives.  The Sr. CRA will work closely with a cross-functional team in a fast-paced high growth environment team to ensure that clinical trials are conducted on time and within budget, and in accordance with applicable GCP/ICH guidelines and other regulatory requirements.

Primary Responsibilities:

  • Participate in preparation of vendor requirements and project scope and selection of study vendors.
  • Manage vendors to ensure timely and quality deliverables (e.g. central laboratory, imaging).
  • Provide study progress updates to CTM and other stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues.
  • Provide monitoring oversight through review of monitoring schedules, metrics and reports.
  • Participate in study monitoring visits, including CRA oversight visits.
  • Participate in and, if appropriate, facilitate cross-functional study execution team meetings; liaise with other functional areas to coordinate clinical study activities.
  • Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.
  • Develop study plans and participate in system set-up (e.g. UAT of EDC, IRT).
  • Participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables.
  • Review clinical study plans, reports, and study metrics.
  • Participate in study feasibility assessments and selection of countries and sites for study conduct.
  • Participate in creation and conduct of study-specific training at investigator meetings.
  • All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with Pliant SOPs.

Requirements:

  • Bachelor’s degree required.
  • 6-9 years of experience working with CROs to manage clinical trials in US and ex-US.
  • Experience independently managing vendors (e.g. imaging, central lab, etc.).
  • Excellent organizational skills and attention to detail.
  • Effective communication and interpersonal skills.
  • Able to set priorities and juggle multiple demands.
  • Able to think critically and be a proactive problem-solver.
  • Able to work independently while exercising initiative, flexibility and sound judgment.
  • Comfortable working with different levels of the company including senior level management.
  • Demonstrated proficiency in Microsoft Word, PowerPoint and Excel.
  • Ability to operate in alignment with Pliant’s values

Medical Director

Medical Director

Pliant Therapeutics is an early stage biopharmaceutical company focused on the discovery and development of novel therapies for 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 Medical Director to join our team and contribute to our mission.

Position Overview:

Reporting to the VP, Clinical Development, the Medical Director manages the clinical development of drug candidates, including phase I-III studies and across multiple therapeutic areas, and will assume a hands-on role in the strategic planning, implementation and oversight of clinical trials

The successful hire will have relevant experience in clinical development within pharmaceutical or biotech industry (At least 5 years). Strong background and interest in underlying science and mechanism of action of therapeutics is required.  Candidate will be responsible for designing and working closely with all functions to enable clinical development goals and deliverables as well as implementation and medical monitoring of clinical trials in early and late stage development.

Essential Duties and Responsibilities

  • Develop protocols to execute clinical development strategies
  • Work cooperatively with Clinical Operations and designated CROs to execute the programs (e.g. lead study start up and database lock medical monitoring activities; address medical monitor inquiries from sites or Operations; perform data and codingreviews; draft/present clinical slides for Investigators Meeting, Advisory Boards and therapeutic/monitor training; review draft CRFs, etc.)
  • Assure the Clinical Science department works closely with Research and Clinical Pharmacology, Regulatory, Drug Safety/Pharmacovigilance, Medical and Affairs as appropriate for effective execution of various programs
  • Write/edit clinical reports, investigator brochures, conference abstractsand clinical aspects of Regulatory submissions; supports all other Regulatory activities, IND and NDA related questions
  • Other duties commensurate with position as assigned
  • Advanced knowledge and training in clinical research, with emphasis on the medical and regulatory requirements as related to clinical research and study design. Experience across all phases of drug development is desired, earlier phases preferred.
  • Knowledge and experience in writing clinical development plans and protocols, providing medical monitoring,clinical trial budgeting and interaction with with regulatory agencies.

***Domestic and global travel may be required

Knowledge and Skill Requirements:

  • M.D. degree with a minimum of 5 years industry experience, in the management and execution of phase I-III trials with credible therapeutics
  • Demonstrated ability to independently evaluate, interpret and present complex scientific data
  • Sound understanding of statistics and demonstrated ability to critically evaluate complex drug development programs
  • Demonstrated ability toteam-work within a multi-disciplinary team of peers and outside experts
  • Excellent communication skills including written, oral, and presentation skills.Evidence of publication of original scientific papers in translational and/ or clinical research will be valued.
  • Able to work effectively in a small dynamic organization; ability to assume multiple roles and responsibilities and meet aggressive goals
  • Ability to analyze complex situations and propose solutions to fundamental problems leveraging drug development knowledge
  • Strongpeople management skills that focus on teamwork and building alliances; ability to resolve conflicts and to negotiate effectively.
  • Strong advocate for teamwork with the initiative to develop consensus and the ability to positively manage challenge.
  • Ability to effectively collaborate with affiliate and contract personnel as required
  • Positive approach to work and ability to motivate team members to meet timelines and project goals is required
  • Ability to develop strong relationships with major investigators and key opinion leaders within therapeutic area