Senior Manager, Clinical Scientist

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Ensure the successful implementation of clinical development programs and deliverables in collaboration with the organization, external vendors, academic partners, and collaboration associates.

• Collaborate within a matrix alongside the Medical Director and functional representatives to carry out activities within the defined scope, compliance, budget, and timelines.

• Assist in the establishment and expansion of Clinical Development functions and global capabilities.

• Facilitate the creation, updating, and review of clinical and regulatory documents, which include protocols, informed consent forms, Investigator Brochures, clinical study reports, publications, IND clinical sections, annual reports, safety update reports, charters, management plans, manuals, and SOPs.

• Support both clinical and scientific components of clinical study design, implementation, execution, analysis, interpretation, and documentation.

• Provide clinical and scientific expertise for investigator/site personnel and vendor selection.

• Educate internal colleagues, CRO staff, and study site personnel regarding the therapeutic area, molecule, and/or clinical protocol.

• Offer scientific and medical support throughout clinical trials and address inquiries from sites, IRBs/IECs, Health Authorities, and CROs.

• Review, query, and analyze clinical trial data.

• Partner with the Medical Director on medical monitoring, patient eligibility, and study treatment-related inquiries.

• Present clinical trial data to internal and external stakeholders.

• Create slide decks related to clinical studies and programs.

• Represent clinical studies or development programs on teams or sub-teams.

• Establish and maintain relationships with KOL/investigator networks; organize and present at KOL advisory boards and investigator meetings; engage with advocacy groups.

• Conduct or contribute to research in therapeutic areas/indications and competitor analysis.

• Build connections with internal experts.

• Develop, monitor, implement, and report on goals and objectives.

• Ensure adherence to compliant business practices.

⛳️ Requirements

• A minimum of a Bachelor's degree is required.

• At least 3+ years of experience and proven success in a similar role within other biotech or pharmaceutical firms.

• 1-2 years of experience in the oncology therapeutic area.

• Prior involvement in an Early/Late clinical development program is crucial.

• Clinical oncology experience is mandatory for Late Phase; preferred for Early Phase.

• Familiarity with GCP and ICH Guidelines.

• Willingness to collaborate with colleagues in a global environment.

• Ability to travel approximately 25% for work-related purposes.

• Knowledge of standard Clinical Development IT solutions in the industry.

• Strong problem-solving and risk-mitigation skills.

• Capability to work independently and foster working relationships throughout the organization and with business partners.

• Exceptional time management and organizational skills.

• Proficient in managing multiple projects in a dynamic environment.

• Proficient in computer-based tools including Word, PowerPoint, and Excel.

• An advanced degree such as PharmD, PhD, or MD is preferred.

🏝️ Benefits

• Annual performance incentive bonus.

• Equity for new hires.

• Ongoing equity based on performance.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401k matching program.

• Flexible time off policy.

• Paid holidays, including a year-end shutdown.