Sr. Scientist, DMPK

Sr. Scientist, DMPK

Description: 

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 meeting unmet medical needs for patients and physicians. The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules. The company is seeking passionate, creative and dedicated scientists to join our team and contribute to our mission.

Position Overview:

Pliant is seeking a versatile, self-motivated person to become an integral part of the DMPK team.  This position will be the drug metabolism and pharmacokinetics (DMPK) lead on project teams developing small molecule modulators of clinically meaningful targets in fibrosis.

This role will interact and collaborate cross-functionally with scientists in other groups, including chemists, biologists, biochemists, structural biologists, and computational chemists.

Job Responsibilities:

  • Serve as DMPK subject matter expert on dynamic cross-functional teams, provide in vitro and in vivo drug disposition data, interpretation, and presentations to teams.
  • Work closely with internal and external resources to assure a high level of quality and timely delivery of DMPK support.
  • Design and perform PK and PK/PD analyses to answer translational questions and to provide guidance for project teams.
  • Supervise associate scientists as required.

Qualifications/Experience: 

  • Requires a highly motivated individual with PhD degree in life sciences with 3-7 year experience.
  • Demonstrates excellent scientific skills in the design, execution and analysis of DMPK studies as well as organized data management and planning skills
  • Good verbal and written communication skills, demonstrated ability to work effectively in cross-functional teams
  • Requires hands-on experience in pharmacokinetics, drug metabolism or transporters

Expertise and experience in one or more of the following areas:

  • Mechanistic PK and pharmacodynamics (PD) analysis, design, interpretation, simulation, and reporting to provide guidance for drug discovery and development projects
  • Metabolite and metabolic soft-spot identification to facilitate structure-based discovery
  • Bioanalysis with previous experience in applying automation for higher throughput

 

Sr. Research Associate, Medicinal Chemistry

Sr. Research Associate, Medicinal Chemistry

Description:

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 patients and physicians.  The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules.  The Company is seeking passionate, creative and dedicated scientists to join our team and contribute to our mission.

Position Overview:

Immediate openings are available for Sr. Research Associates in Chemistry.  This individual will join a dynamic and growing multidisciplinary team focused on discovery and advancement of new drug candidates and disease biomarkers.  The primary responsibility of this position will be the synthesis, purification, and characterization of novel biologically active molecules. The successful candidate will work under the direct supervision of a Scientist or Sr Scientist.

Responsibilities:

  • Conduct multistep syntheses of complex small molecules supported with detailed characterization of intermediates and final products.
  • Contribute to exploratory research and collaborate closely with colleagues in other groups.
  • Summarize/interpret results and present findings in research meetings.
  • Execute experiments and tasks following appropriate laboratory/technical procedures.
  • Evaluate and clearly report experimental results to supervisor and colleagues on a routine basis with special attention to data quality and reproducibility.
  • Learn new laboratory techniques, troubleshoot experiments, and ensure experiments are performed to a high standard.
  • Utilize scientific literature and databases such as SciFinder to design and implement efficient synthetic routes.
  • Propose new compounds for synthesis based on synthetic knowledge and SAR.
  • Contribute to the design of experiments and new targets.

Job Requirements:

  • BS/MS in Chemistry with 3-8 years of relevant experience in synthetic organic/medicinal chemistry with potential to learn and adapt in a fast moving environment.
  • Demonstrated experience in organic synthesis, chromatographic purification methods, and compound characterization using modern analytical techniques (NMR, MS, HPLC, etc.).
  • Organized, detail-oriented, excellent record-keeping skills, excellent verbal and written communication skills.
  • Ability to work independently and perform well in a team environment
  • Understanding of medicinal chemistry concepts.

 

Senior Scientist, Analytical and Research Development

Senior Scientist, Analytical and Research Development

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 address 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 Scientist of Analytical and Research Development will report to the Head of Chemistry and will be part of the CMC team. In this role, they will lead both non-GMP and GMP activities requiring analytical chemistry input for all IND and clinical small molecule projects.

Primary Responsibilities:

  • The ideal candidate will provide analytical method development, validation and transfer for drug substances, drug products, GMP starting materials, intermediates, in-process controls to enable clinical and commercial manufacturing.
  • Provide direction, oversight and technical expertise for analytical activities, play a key role in troubleshooting and change management at external CMO/CROs.
  • Apply a science-driven, phase-appropriate and risk-based analytical development strategy to support projects from IND to clinical development to commercial production.
  • Author regulatory dossiers and development reports. They must have the ability to work independently and as an effective and engaged team member in a fast-paced
  • Be responsible for GMP related activities such as DS/DP release, stability testing, OOT/OOS investigation support, and issuance and maintenance of specifications.
  • Manage analytical and quality control activities at CROs/CMOs to support release, stability testing, data integrity, and development activities.
  • Author, review, and/or approve analytical and QC sections of regulatory submissions, SOPs, STMs, specifications, protocols, reports, OOT/OOS investigations and other controlled documents as needed.
  • Responsible for strategic planning and obtaining cross functional alignment to enable project success.
  • Evaluate and implement new processes, best practices, and technologies through awareness of industry and regulatory trends.
  • Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
  • Ensure all QC procedures follow FDA/EMA guidelines and internal/CMO SOPs
  • Oversee release testing of all raw materials, intermediates, APIs and DPs
  • Manage inventory and distribution of reference standards through external partners
  • Interface with other functions, such as Process Chemistry, Contract Manufacturing, Pharmaceutical Technology, Quality Assurance, Regulatory, Clinical Pharmacology, Clinical Sciences, Supply Chain, Early Development, and Project Management
  • Perform other duties as assigned using Core Competencies, Knowledge and Skill
  • Supervise a BS/MS analytical chemist

Requirements:

  • Thorough understanding of pharmaceutical and analytical development of small molecules
  • In-depth knowledge and hands-on experience with HPLC, GC, MS, and compendial method development and testing
  • Ability to interpret and apply cGMPs, USP/EP standards, ICH guidelines and industry best practices
  • Proven experience in handling confidential and sensitive information with the ability to exercise discretion and show good judgment
  • Must have excellent customer-service orientation, high degree of professionalism, and ability to work independently.
  • Daily demonstrates a positive, ‘can do’ and service oriented attitude with a commitment to detail
  • Strong oral and written communicator
  • Self-motivated to take ownership of and follow through with tasks
  • Ability to balance competing priorities and triage to pivot quickly to meet tight deadlines
  • Skilled in developing collaborative internal and external relationships
  • Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint), quality systems (e.g. TrackWise), and statistical software (e.g. JMP)

Communication & Interpersonal Skills:

  • Excellent verbal and written communication skills
  • Capable of driving decisions through well designed, effective presentations
  • Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company

 

Requirements:

Education

  • PhD degree in Analytical Chemistry in Analytical Chemistry with extensive industry experience.

Experience

  • Requires 7+ years of progressive experience in the biopharmaceutical/biotech industry, GMP environment.
  • Knowledge of modern pharmaceutical practices and techniques with a solid scientific understanding of drug development process. Experience with solid dosage formulation development and manufacturing is a requirement.
  • Significant experience working in an outsourcing environment as well as internal laboratories.
  • A strong track record of scientific achievements including external publications and presentations.
  • Prior experience in developing fixed-dose combination is highly desired.
  • Demonstrated problem solving skills, strategic thinking, and proven leadership

 

Travel, Physical Demands And Work Enviroments:

  • Regularly required to operate standard office equipment
  • Ability to work on a computer for extended periods of time
  • Regularly required to sit for long periods of time, and occasionally stand and walk
  • Regularly required to use hands to operate computer and other office equipment
  • Close vision required for computer usage
  • Occasionally required to stoop, kneel, climb and lift up to 20 pounds

 

 

 

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

Scientist/Sr. Scientist Biology – Antibody Engineering

Scientist/Sr. Scientist Biology – Antibody Engineering

Description:

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 patients and physicians. The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules. The Company is seeking passionate, creative and dedicated scientists to join our team and contribute to our mission.

Position Overview:

Immediate openings are available for Scientists/Sr. Scientists with experience in the fibrosis/inflammation area. Experience in cell signaling and previous research industry experience in drug development is a plus. This individual will join a dynamic and growing multidisciplinary team focused on discovery and advancement of new drug candidates and disease biomarkers. The primary responsibility of this position will be related to the field of fibrosis, notably in the discovery of novel signaling pathways.

Responsibilities:

  • Plan and execute experiments related to the evaluation of novel targets and signaling pathways.
  • Make detailed observations, record and analyze data.
  • Troubleshoot experiments.
  • Advance drug discovery programs by interacting with other biologists, chemists and external collaborators.
  • Contribute effectively to patent, report and scientific publication writing.
  • May have the opportunity to manage one or more Research Associates.

Job Requirements:

  • PhD. in Biochemistry, Molecular Biology, Structural Biology, or related field.
  • A minimum of 5 years of experience working in antibody engineering, preferably in the pharmaceutical or biotechnology industry.
  • Experienced in antibody humanization and maturation.
  • In-depth knowledge of state-of-the-art technologies and methods for design and optimization of antibody and antibody-based therapeutics.
  • Hands-on experiences with phage-display, yeast-display, and/or antibody engineering are required
  • Strong molecular biology skills
  • High level of creativity and productivity with strong problem solving skills.
  • Ability to champion the biology efforts into new directions to achieve project milestones.
  • Strong evidence of conceptual thinking, active follow through and vigorous scientific curiosity.
  • Proven ability to work well with others in a dynamic and highly collaborative environment.
  • Exceptional interpersonal, verbal and written communication skills

 

Associate Director/ Director, Formulation Development

Associate Director/ Director, Formulation Development

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 address 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 Associate Director/ Director, Formulation Development will lead the drug product development function. Responsibilities will include leading, planning and managing the technical and business-related activities associated with drug product development and manufacturing of clinical formulations, primarily solid oral dosage forms, at contract development sites. The Associate Director/ Director, Formulation Development will report to the Head of Non-Clinical Development, and will work closely with a cross-functional team in a fast-paced high growth environment team to ensure progression of Pliant small molecules from discovery through development.

Primary Responsibilities:

  • Design and select enabling preclinical formulations for pharmacology and toxicology studies.
  • Implement innovative enabling technologies as needed.
  • Develop strategies and execute plans for drug product development from first time in human formulations through development of NDA ready formulations in accordance with timelines and requirements of overall development programs.
  • Identify and qualify CMOs for Pliant programs, including analytical CMOs, manufacturing CMOs and packaging/labeling and distributors.
  • Lead formulation and process development, technology transfer and clinical manufacturing activities at CMO sites. Lead analytical method development and stability assessments.
  • Review and approve manufacturing documents, protocols and reports.
  • Write technical reports and author CMC sections of regulatory submissions related to drug product from IND through NDA stage of development.
  • Effectively participate in cross- functional team meetings from discovery through development.
  • Deliver drug product to meet clinical program needs, on schedule and within budget.

Requirements:

  • PhD in Pharmaceutical Science or related field
  • 7+ years experience in pre-formulation and formulation development for small molecules, preferably solid dosage forms, 3+ years in managing outsourced development activities
  • Must have experience in formulation and process development from early to late phase development.
  • Good working knowledge of GMP requirements for drug product development and manufacturing.
  • Solid understanding of ICH, FDA, EMA guidances in CMC and Quality areas
  • Effective written and oral communication and interpersonal skills.
  • Experience in building and leading a formulation group in pre-formulation, formulation development, and process selection and scale up, and oversight of GMP manufacturing of drug products.
  • Excel in team settings with ability to think critically and work independently.

 

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