Director, Clinical Sciences

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