Senior Principal Scientist, Early Phase Clinical Development Specialist

at  Altasciences

YOUR NEW COMPANY!

At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them.  No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.
We are better together and together We Are Altasciences.

ABOUT THE ROLE

The Senior Principal Scientist, Scientific Affairs is responsible for providing strategic and scientific guidance related to global clinical drug development. They are also responsible for gathering and synthesizing information for the purpose of providing high‑quality study design documents to support sponsors’ research programs and to provide overall scientific support to the Regulatory Submission, Medical Writing and Scientific Affairs departments.

WHAT YOU’LL DO HERE

• Work closely with business development team and sponsors to understand sponsor’s needs and interests, and to provide strategic and scientific guidance related to global clinical drug development
• Interact with sponsors as scientific consultants to encourage engagement in scientific activities aligned with clinical trials
• Analyze experimental results and make recommendations for future research projects
• Supervise and prepare research synopses for studies of any complexity involving pharmacokinetic (PK) and/or pharmacodynamic (PD) assessment of drugs in different early stage study designs.
• Compile information from investigator’s brochures, product monographs, scientific literature, guidance documents, and previous studies to generate study design.
• Provide scientific input into client-provided proposals.
• Maintain a positive, result orientated work environment, building partnerships with cross-functional departments, maintaining a positive team-based culture
• Support business development for proposals and costing; support bid defense meetings
• Participate in the development of standard operating procedures (SOPs).
• Participate in feasibility meetings to optimize future study designs, when needed.
• Interact with regulatory agencies as well as with regulatory team regarding issues/feasibility with study designs.
• Review and provide support in answering deficiency letters from regulatory agencies, as required.
• Perform scientific review of protocol and clinical study report (CSR) documents as well as preliminary analyses for studies of any complexity prepared by other team members.
• Contribute to and guide research for the development of analytical range(s) for new analytical methods with the Analytical Method Development department.
• Coordinate with internal teams to deliver high-quality documents in accordance with agreed upon timelines.
• Conduct all work in compliance with SOPs, Good Clinical Practice (GCP), and all regulatory guidelines.
• Maintain familiarity with client expectations and produce documents consistent with these.
• Maintain thorough understanding of regulatory guidelines of related authorities (Pharmaceutical Drugs Directorate [PDD], Food and Drug Administration [FDA], and European Medicines Agency [EMA], etc.) as well as International Conference on Harmonisation (ICH) and GCP procedures.
• Participate in departmental or interdepartmental quality improvement initiatives.
• Train and mentor other team members
• May assist in coordination of team workload.
• May participate in scientific meetings, conferences, and courses/workshops representing Altasciences.
• Maintain and participate in the objectives of the department.
• Other duties as assigned.

​ What You’ll Need to Succeed

• Master’s Degree in health-related sciences or relevant field or equivalent experience, advanced degree preferred
• Leadership skills.
• Excellent verbal and written communication skills.
• Critical thinking skills and ability to acquire and apply knowledge quickly.
• Ability to interpret and organize complex scientific data effectively.
• Professional attitude and strong interpersonal skills.
• Ability to work well with a multi-disciplinary team of professionals.
• Client-focused approach to work.
• Flexible attitude with respect to work assignments and new learning.
• Ability to prioritize workload.
• Thorough understanding of clinical research, pharmacology and PK, drug development process, and applicable regulatory guidelines.
• Strong computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems.