The Director Pre-Clinical will be accountable for all aspects of pre-clinical evaluation of the molecules in the company portfolio, including toxicology and ADME/DMPK work.  

• Formulates pre-clinical development plans.

• Aligns pre-clinical work with clinical plans.

• Project Management of pre-clinical plans including budgeting and timelines.

• Partnership with internal and external experts.

• Identifies any safety risks and develops contingency plans to manage the risk.

• Responsible for creating/updating the preclinical components of regulatory and safety documents (e.g., CIB, IND, NDA, CTX, CTA).

• Interaction with regulatory authorities.

• Identification, management and supervision of company work at contract facilities.

• Be the Study Monitor, or designate a Study Monitor, to act on behalf of the company to ensure that the quality of contracted work meets the appropriate scientific, technical, and regulatory standards.

• Prepares reports as needed representing analysis of results.

• Manage team members.

• Strong scientific background in life sciences, pharmacology, toxicology or chemistry

• Ability to critically analyze scientific data

• Experience in the science and conduct of all phases of ADME and toxicology studies.

• Excellent communication skills.

• Attention to detail

• Demonstrated experience with regulatory agency interactions.

• DVM or PhD in Toxicology or a related scientific field

• Atleast 10 years experience in a pharmaceutical company or Contract Research Organization, including project management and leadership experience

• Highly motivated and independent scientist

• This role will be reporting to the CEO.

• International and local travel will be required.

• Core work hours, Mon-Friday.

• Position is located in Bangalore, India

• Oversee the development and maintenance of company SOPs and ensure that they align with all applicable regulations and practices. 

• Oversee the development and maintenance of the training curriculum maps for company employees.

• Respond to critical monitoring and audit findings discovered at an external partner or within the company itself.

• Conduct periodic re-assessments of company quality and training systems.

• Strong teamwork/interpersonal skills and a demonstrated ability to influence at levels across many disciplines, both externally and internally

• Strong communication skills

• At least 10 years work experience directly dealing with GCP, GLP, and/or GMP requirements at a pharmaceutical or similar company or Contract Research Organization.

• B.S. degree in a science related. Advanced degrees and/or additional degrees in preferred.

• This role will be reporting to the CEO

• International and Local travel will be required

• Core work hours, Mon-Friday

• Position is located in Bangalore, India

The Director CMC will be accountable for creating and leading the implementation of integrated CMC plans for the company portfolio of molecules from candidate selection through early phase clinical development for both small and large molecules.

• Create, lead and manage the implementation of integrated CMC plans and manage any changes to a plan.

• Ensure timely delivery of material for both pre-clinical and clinical studies.

• Manage a group of manager level CMC staff to implement the integrated CMC plans for each molecule in the company portfolio.

• Build, establish and communicate with a network of external contract vendors of appropriate quality and technical capability.

• Build, establish and communicate with a network of CMC content experts.

• Negotiate CMC contracts with external vendors and communicate their implementation with procurement.

• Partner with company GMP Quality to ensure all clinical supplies are manufactured, tested, shipped and stored in full accordance and compliance with the GMP regulations.

• Together with company GMP  Quality, Toxicology and Regulatory, prepare and approve specifications for drug substances and drug products intended for clinical use in accordance with applicable regulatory requirements.

• Preparation of CMC regulatory documentation for submission to allow clinical trial initiation in multiple countries.

• Advanced graduate degree (MS or Ph.D.) in Chemistry related sciences, e.g., Organic Synthetic Chemistry, Medicinal Chemistry, Analytical Chemistry, Pharmaceutical Sciences or Engineering

• Demonstrated leadership, preferably in more than one related CMC area and drug development experience with many molecules of varying degrees of complexity.

• At least 10 years experience in cGMP related CMC drug development or manufacturing.

• Experience in the preparation of CMC regulatory documentation.

• Strong teamwork/interpersonal skills and a demonstrated ability to influence at many levels across many disciplines, both externally and internally.

• Strong communication skills.

• Demonstrated project management skills.

• This role will be reporting to the CEO

• International and Local travel will be required

• Core work hours, Mon-Friday

• Position is located in Bangalore, India

The Clinical Pharmacologist is responsible for interpreting non-clinical pharmacology, toxicology, and drug metabolism data to develop a strategic sequence of studies that addresses key early clinical development objectives in an efficient manner. 

• Provide clinical pharmacokinetic (PK) and pharmacodynamic (PD) expertise to the company projects for multiple drug development programs in a variety of therapeutic areas

• Select and manage CROs and independent contractors that provide PK and clinical pharmacology services

• Manage and review PK/PD output from third party providers, including design, analysis, interpretation and reports.

• Preparation of, or assistance in the preparation of, PK/PD components of protocols, project development plans, briefing documents, INDs, CTAs and and other regulatory documents.

• Interactions with regulatory agencies.

• Bringing new technologies to the JV protocols as needed.

Education/Experience
/Training                     :          

• Advanced knowledge in the area of clinical pharmacology and clinical pharmacology studies.

• Experience in clinical research and the drug development with emphasis on clinical pharmacology.

• Experience in providing strategic input to global clinical development plans.

• Experience in regulatory interactions.

• Excellent communication skills.

• Knowledge of and experience with appropriate computational data analysis tools (e.g., WinNonLin).

• Experience with population-based pharmacokinetic methods.

• Ability to apply PK theory using SAS programming.

• PhD, Pharm D, or MS degree in pharmaceutics, pharmacology, pharmacokinetics, or related discipline or MD degree with equivalent additional training.

• At least 6 years drug development experience.

Miscellaneous             :       

• This role will be reporting into the CEO/CMO for JV.

• Some international and local travel will be required.

• Core work hours, Mon-Friday.

The Biostatistician develops, or assists in the development of, protocol designs, clinical plans, and data analysis plans in collaboration with the other scientific staff, and is responsible for working with pre-clinical and clinical staff for the analyses and reporting of the data.

• Provide input on study designs and develop the statistics section of protocols and study reports.

• Selecting statistical methods for data analysis, and conducting the actual analysis once a reporting database is created.

• Collaborate in the planning and implementation of data quality assurance plans. 

• Respond to regulatory queries and to interact with regulators.

• Selection of external network of vendors for statistical support.

• Manage external network of vendors to ensure on time and on budget project delivery.

Education/Experience
/Training                         :                              

• Proficient in the SAS programming language

• Interpersonal communication skills for effective team consultation.

• Teamwork and leadership skills.

• Self-management skills with a focus on results for timely and accurate completion of competing deliverables

• Resource management skills.

• Creativity and innovation.

• Demonstrated problem solving ability and strategic thinking.

• At least 5 years experience in drug development.

• Experience working with third party providers.

• M.S., Ph.D. in statistics/biostatistics

Miscellaneous               :     

• This role will be reporting to CEO.

• International and local travel will be required.

• Core work hours, Mon-Friday.

• Position is located in Bangalore, India

  The Director Safety will be accountable for all safety aspects of clinical drug development.

• Provide oversight for the development of regulatory documents related to safety including investigator brochures, clinical trial protocols and study reports.

• Responsibility for reviewing serious adverse events in all clinical trials.

• Conducting interim safety reviews during studies

• Regulatory interactions.

• Identify and manage third party providers related to safety.

Education/Experience
/Training                         :                              

• MD/PhD in health sciences with experience in safety monitoring in all phases of clinical trials.

• Clinical experience.

• Excellent communication skills.

• Team player.

• Ability to work in multiple therapeutic areas.

Miscellaneous               :     

• This role will be reporting to CEO.

• International and local travel will be required.

• Core work hours, Mon-Friday.

• Position is located in Bangalore, India