Senior Analyst/ Manager, Financial Planning and Analysis

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 Sr Financial Analyst/ Manager is responsible for strategic, financial and operational activities and will collaborate with a wide array of departments and program teams.   The position will report to the CFO, and will be responsible for budgets, forecasts, long-range plans, variance analysis and other ad-hoc reports. This role will be a key part of the Finance team and will work closely with Corporate and Business Development.

Primary Responsibilities:

  • Help lead the budgeting, long-range planning and quarterly forecasting efforts.
  • Provide financial planning, analysis, and support to drive decisions.
  • Manage/understand variances to plan for R&D spend on a monthly, quarterly and annual basis.
  • Report/budget the allocation of FTE resources on a monthly basis.
  • Assist with the presentation of monthly results to program leads/department heads.
  • Special projects, system implementation, and ad-hoc analysis, as needed.
  • Cross-train on other key functions within the Finance team.
  • Build and maintain long-term projection and strategic valuation models to aid in decision making.

Requirements:

  • Bachelor’s degree and/ or Master’s degree in Economics/ Accounting/ Finance or similar discipline.
  • 2-5 years of finance experience in the biotechnology or pharmaceutical industry, investment banking and/ or strategic consulting.
  • Strong financial modeling and analytical skills; highly proficient in MS Excel.
  • Ability to navigate and influence in a matrixed organizational structure; highly collaborative.
  • Attention to detail, with ability to see the big picture.
  • Passion to understand the business.
  • 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.

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

 

 

 

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.

 

Senior Clinical Trial Manager