Senior Clinical Scientist

OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as a remote Senior Clinical Scientist. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.


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




EXPERIENCE

•    At least 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


EDUCATION

•    Bachelor’s Degree, Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc) is preferred.

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.


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