Senior Clinical Scientist

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Posted:

Location: Cambridge, Massachusetts

Company: Planet Pharma Group

Contact: Applications

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Summary of Key Responsibilities
The Contract Sr. Clinical Scientist will ideally be familiar with drug development and regulatory requirements and will deploy this expertise in the execution of a number of key responsibilities:

*Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical SubTeam
*Maintains proficient understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape as well as maintaining compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
*Possesses proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late-stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature.
*Collaborates with medical writing to author clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments
*Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and resolve cross functional comments with minimal support
*Leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal stakeholders
*Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
*Proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies
*Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs; Reviews clinical data review plan and authors medical monitoring plan for assigned studies/program

*Qualifications
*Bachelor’s Degree, Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc) is preferred. ? 10 years of pharmaceutical clinical drug development experience
*Experience within CNS, Rare Disease or Cardio-metabolism preferred
*Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
* Ability to manage multiple competing priorities with good planning, time management and prioritization skills
*Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions
*Proficient scientific expertise to propose, design, and execute clinical research and development studies, and authors documents related to clinical trials, such as medical monitoring plan, SAPs, informed consent and clinical components of the Clinical Study Reports
*Interact with key stakeholders across Clinical Development functional areas
*Problem solving, prioritization, conflict resolution and critical thinking skills
* Strong communication, technical writing, and presentation skills experience

Pay ranges between 98-108/hr based on experience