Principal Clinical Scientist - Clinical Development

Job Summary

Reporting to the VP Clinical Development, the Principal Clinical Scientist will contribute to the execution of the Phase 3 clinical development programme for EFX. Key responsibilities include, but are not limited to clinical protocol development, medical monitoring, data analysis and reporting of results for regulatory submissions or scientific presentations and publications. This position demands strong collaborative and communication skills, including the ability to engage with a diverse range of internal and external stakeholders.

Job Responsibilities

• Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution
• Support medical monitoring activities for ongoing clinical trials.
• Support/manage preparation of materials for trial-related clinical committees such as Data Monitoring Committees, Adjucation Committees, etc.
• Contribute to planning, authoring, and critical review of documents submitted to regulatory authorities and ethics committee/IRBs as required (e.g., Protocols, CSRs, IB, clinical briefing documents).
• Contribute to the strategic planning, authoring, and critical review of scientific data disclosures (e.g., slide presentations, posters and publications).
• Co-ordinate aggregate report preparation (e.g., DSURs, PSUSARs, ASR), and safety management plans (SMPs) in collaboration with external vendors
• Contribute to engagement with external stakeholders such as vendors, thought leaders or other groups as needed including being the primary liaison with assigned individuals or groups.
• Function as an independent member of the team and represent clinical research at internal cross-functional or external meetings.
• Other duties related to clinical development of EFX as assigned.

Qualifications

• PhD, PharmD or other qualification with relevant professional experience, (e.g. RN, NP, PA)
• At least 5+ years of relevant experience in clinical development in the biopharmaceutical industry
• Direct experience of Phase 3 clinical trial execution and medical monitoring support
• Experience with preparation of documentation for BLA/NDA/MAA submissions desirable
• Knowledge of the regulatory path across the various health authorities (FDA, EMA etc) desirable
• Experience in in Hepatology, Gastrointestinal, Endocrinology or related field, preferred.

Technical Requirements and Skills:

• Familiarity with GCPs, ICH guidelines and FDA/ EMA/CHMP regulations and ability to apply relevant principles, practices and standard to conduct GCP-compliant trials
• Demonstrated ability to author or oversee regulatory documents (e.g protocols, CSRs, briefing packages).
• Strong interpersonal and communication skills; proactive approach.
• Expertise in navigating scientific literature and ability to critically evaluate, interpret and synthesise scientific data,
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, flexibility, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
• Able to work both independently and in a team environment, including with external vendors.
• Detail-oriented, with good organizational, prioritization, and time management proficiencies, and able to work on multiple projects simultaneously.
• Highly proficient in MS Office Suite (Word, Excel and Power Point).

The base compensation range for this position is $148,290 to $259,510. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.  

Akero Therapeutics, a Novo Nordisk company, offers long-term incentive compensation depending on the position's level or other company factors.  

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

The job posting is anticipated to close on February 4th. The Company may however extend this time-period, in which case the posting will remain available on our careers website at https://akerotx.com/job-opportunities.

EEO Statement:

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.