Genuine interest and understanding of the science behind the pipeline.
Proven ability to collaborate in a multidisciplinary team environment.
Strong leadership and communication skills with proficiency in analyzing and presenting clinical data.
In-depth knowledge of clinical trial design, methodology, and regulatory submissions.
Working knowledge of the IND/NDA process; direct experience with NDA/BLA filings preferred.
Ability to engage with diverse stakeholders, including executive leadership and KOLs.
Availability to work in-office 2-3 times per week and travel up to 20%.
Responsibilities
Lead Clinical Scientist for the KER-065 program, representing clinical sciences in cross-functional meetings.
Create key documents such as Clinical Trial Protocols and regulatory submissions with high quality.
Collaborate with biostatistics and clinical teams for timely data analyses and presentations.
Contribute to medical/safety assessments and collaborate with the Pharmacovigilance team.
Plan and lead ongoing medical data reviews with data management and other functions.
Work with Clinical Operations for patient-centric drug development, balancing quality and cost.
Prepare clinical sections of key documents and ensure high-quality medical standards.
Benefits
Opportunity to work on innovative therapies in neuromuscular/neurodegenerative indications.
Collaborative and multidisciplinary team environment.
Engagement with executive leadership and key opinion leaders.
Potential for professional growth and leadership opportunities.
Involvement in high-impact clinical studies and regulatory submissions.
Full Job Description
Job Summary:
Reporting to the VP, Clinical Development Operations, the Director of Clinical Sciences will serve as the lead Clinical Scientist for the KER-065 program or other assigned study. This person will be responsible for designing and initiating clinical trial(s), supporting clinical data review, interpretation of study results and drive a compound through development. The Director of Clinical Sciences will work closely with the VP, Clinical Development Operations and/or the Medical Director to support various study related activities including drafting clinical development plan, target product profile and represent clinical sciences/development in cross functional teams. In addition, they will contribute to workstreams overseeing data quality, including those involved in CRF data collection, data monitoring and cleaning, and generation of data outputs. This position is based in the company's Lexington office and requires some domestic and international travel.
Responsibilities
Function as the lead Clinical Scientist for the KER-065 program or other assigned program and represent clinical sciences in cross function team meetings.
Lead and support creation of key documents (e.g., Clinical Trial Protocols, Investigator's Brochures, Clinical Study Reports (CSRs), regulatory documents including INDs/CTAs, NDAs/MAAs and regulatory responses) with high quality and consistency with the Clinical Development Plan.
Collaborate with biostatistics, clinical development, and other applicable team members to participate in relevant and timely data analyses and presentations for safety monitoring committee meetings, regulatory documents, and internal reviews to support timely program decisions regarding study objectives.
Contribute to the study medical/ safety aspects and risk-benefit assessments, collaborating closely with Pharmacovigilance team.
Plan and lead ongoing medical data review in collaboration with data management and other functions.
Work hand-in-hand with the Clinical Operations team for patient centric drug development, ensuring balancing of high medical quality, trial complexity, as well as time and cost considerations.
Own and ensure preparation for clinical sections of key documents, including Investigator's Brochures, IND summary documents, CTAs, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs.
Contribute to Clinical Study Report (CSR) medical content to ensure high quality expectations on medical standards, provides respective guidance to other members, if needed
Work with the internal team to develop and update key messages on disease states, MOA, target product profile, and scientific platform.
Collaborate with Medical Affairs and other team members on scientific communication of clinical data, including external messaging, publication planning, and congress management.
Author and review abstracts, posters, and manuscripts for publication.
Lead, contribute and drive other initiatives based on the functional goals and corporate objectives.
Qualifications
Genuine interest and understanding of the science supporting the pipeline
Ability to work collaboratively in a highly matrixed, multidisciplinary team setting, and an innovative drive to help the organization succeed
Strong leadership and communication skills and proven proficiency in understanding, analyzing, and presenting scientific and clinical data
Detailed understanding of all aspects of clinical trial design, methodology, statistical concepts, protocol development and implementation, global regulatory submissions, and overall drug development is required
Working knowledge of the IND/NDA process is required. Direct experience with NDA/BLA filings is preferred
Ability to engage and collaborate with diverse stakeholder groups internally and externally, including executive leadership, study investigators, KOLs, and the external medical and scientific community
Ability to be in the company office at least 2-3 times per week
Ability to travel up to 20% required
Education and Experience
Doctorate (MD, PhD, PharmD or equivalent) required; experience developing therapies for neuromuscular/neurodegenerative indications is preferred but not required
Minimum of 5 years of clinical development experience in the pharmaceutical or biotechnology industry is required
This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.
