Senior Clinical Scientist/Associate Director, Clinical Science

Overview

The Senior Clinical Scientist, reporting to the Executive Director of Clinical Development, ensures the successful and timely execution of our Clinical Development Program and its specific deliverables, leveraging cross functional partnerships throughout the organization, external vendors, and academic clinical and preclinical collaborators. The Senior Clinical Scientist works closely in a matrix with the Medical Directors and other drug development specialists to ensure that activities are compliantly executed according to projected scopes, budgets, and timelines. The individual in this position supports the establishment and growth of Clinical Development functions, practices, and workstreams to achieve best-in-class global capabilities and scientifically sound results.

• This position can be based either in our Woburn office or be a remote role
• Our Woburn location welcomes hybrid work!  Local candidates are expected to be on-site 2 days per week.
• Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.

Responsibilities

Key responsibilities:

• Creating, updating, and/or reviewing key clinical and regulatory documents under the guidance of Clinical Development Leadership, including, but not limited to:
  • Clinical trial concepts, synopses, protocols, and amendments
  • Informed Consent Documents
  • Investigator Brochures
  • Clinical Study Reports
  • Abstracts, posters, and manuscripts
  • Clinical sections of INDs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
  • Processes and documents crucial to clinical trial execution, e.g.: charters for safety data monitoring and steering committees, study specific management plans and manuals, SOPs, etc.
• Supporting all clinical and scientific aspects of the design, implementation, conduct, analysis, interpretation, and documentation of clinical studies. Partnering with relevant functions for the successful implementation and execution of clinical studies. Specific tasks will include, but are not limited to:
  • Providing clinical and scientific expertise for selection of investigators and vendors.
  • Training internal colleagues, CRO staff, and study site staff on specific therapeutic areas, therapeutic agents/modalities, and/or clinical protocols.
  • Providing scientific and medical support throughout conduct of a given clinical trial; responding to clinical questions from sites, IRBs/IECs, health authorities, and CROs.
  • Reviewing, querying, and analyzing clinical trial data.
  • Partnering with Medical Directors on medical monitoring activities and responding to patient eligibility and other study related questions, in cooperation with the CRO and/or by interacting directly with study site staff.
• Presenting clinical trial data, both internally and externally.
• Creating or modifying clinical study or program-related slide decks for internal and external use.
• Representing a given clinical study or the Development Program on one or more cross functional teams or sub teams.
• Building and maintaining KOL/investigator networks; organizing OL advisory boards and investigator meetings, engaging with advocacy groups in partnership with Medical Affairs.
• Contributing therapeutic landscape research and competitor analyses.
• Building strong relationships with internal subject matter experts.
• Developing, tracking, executing, and reporting one’s professional goals and objectives.
• Being accountable for compliant business practices.

Qualifications

Educational requirements:

• Advanced degree (e.g.: PharmD, PhD, or MD) within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training, and experience) required.

Experience and skill requirements:

• Minimum of 5 years of experience and success in Clinical Development or a closely related function, with 2-3 or more recent years of development experience in oncology.

• A consistently high level of communication (written and verbal).
• Excellent interpersonal and collaboration skills.

• Knowledge of GCP and ICH Guidelines.

• Flexibility to work with colleagues in a global setting.

• Able to engage in work-related travel up to 30% of the time.

• Demonstrated success working in a global cross-functional pharma environment.

• Knowledge of industry standard clinical development computer programs (eg. Spotfire), in addition to crucial business software (PowerPoint, Office, etc.) expected.

• Strong problem solving and risk-mitigation skills.
• Confident, positive attitude, and enthusiastic.
• Strategic and creative thinker.
• Ability to work independently and to foster working relationships throughout the organization and with business partners to achieve goals.
• Solid time management and organizational skills.
• Ability to manage multiple projects in a fast-paced environment.

• A firm understanding of pharma-related biostatics is a strong plus.
• Experience with development and support of SOPs and policies is a plus.