Clinical Scientist

Job Title: Clinical Scientist

Location: EU / CET preferred (remote)

Travel: Up to 10%, including investigator meetings, site visits, as needed

Position Summary

Oak Hill Bio is a clinical-stage biotechnology company focused on acquiring and developing outstanding rare disease drugs that have been deprioritized by big pharma.

As a key scientific partner, providing support to the Senior Medical Director, the individual in this role supports all clinical science activities for BEACON, our global, pivotal Phase 3 trial in Angelman syndrome and the rugonersen Expanded Access Program (EAP), which provides continued access to eligible participants transitioning from the TANGELO Optional Open-Label Extension.

The individual in this role works hand-in-hand with the Senior Medical Director on day-to-day scientific and medical execution, protocol interpretation, data review, safety monitoring support, and cross-functional deliverables while also independently managing defined workstreams.

Responsibilities

Phase 3 (BEACON) Clinical Science Support

• Support day-to-day scientific and clinical execution of BEACON, including protocol interpretation, eligibility, and site conduct issues.

• Help develop and maintain the protocol, amendments, informed consent forms, statistical analysis plan inputs, and core study documents.

• Develop and review CRFs/eCRFs, edit checks, and data review guidelines with Data Management and Biostatistics.

• Review accumulating safety, efficacy, and procedural data to identify trends, outliers, and quality issues.

• Prepare and review materials for DSMB and other safety oversight meetings.

• Develop and deliver investigator and site training on IT administration, sham procedures, BSID-4 and other assessments, and protocol requirements.

• Coordinate responses to investigator and site medical or protocol questions with the Senior Medical Director and Field Medical Director.

• Prepare clinical study reports, interim analyses, and data summaries.

• Provide clinical science input for the planned open-label extension after primary endpoint assessment.

Expanded Access Program (EAP) Support

• Support daily clinical science activities for the rugonersen EAP, including physician requests for patients transitioning from the TANGELO Optional Open-Label Extension.

• Help assess patient eligibility against EAP criteria and coordinate documentation and approvals.

• Monitor safety and review EAP data, including adverse events and dosing continuity.

• Serve as a scientific contact for treating physicians on protocol and administration questions, in coordination with the Senior Medical Director.

• Maintain EAP regulatory and tracking records and support health authority or IRB/ethics committee communications.

• Identify and escalate EAP safety or scientific signals relevant to BEACON.

Cross-Functional & General Clinical Science Activities

• Partner with Biostatistics, Data Management, Clinical Operations, Drug Safety, Regulatory, and Medical Affairs across BEACON and the EAP.

• Track literature and the Angelman syndrome and related neurodevelopmental treatment landscape, summarizing key developments internally.

• Prepare scientific and clinical summaries, presentations, and briefings for governance, board, and external engagements.

• Contribute clinical science input to abstracts, manuscripts, and congress materials with Medical Affairs and Scientific Communications.

• Support evolving ad hoc clinical development needs.

• Improve clinical science processes, documentation, and cross-functional workflows as the program grows.

Building the OHB Team

• Keeps patients at the center of every decision

• Does high-quality work and owns the results

• Works well with others to deliver team goals

• Seeks feedback, keeps learning, and helps others grow

Qualifications & Experience

• Advanced degree in a life science, clinical, or health field preferred (PharmD, PhD, MS, RN, or equivalent); equivalent experience considered.

• 3+ years of pharmaceutical or biotechnology clinical science, research, or development experience, ideally supporting Phase 2/3 trials.

• Rare disease, neurology, genetics, or neurodevelopmental experience strongly preferred; Angelman syndrome, ASO therapeutics, or intrathecal products a plus.

• Knowledge of clinical trial design, including blinded/sham-controlled studies and expanded access frameworks.

• Experience reviewing safety or efficacy data and identifying quality or safety trends.

• Familiarity with ICH-GCP, regulatory requirements, and core trial documents.

• Strong scientific writing and communication skills for varied audiences.

• Excellent organization, attention to detail, and ability to manage concurrent workstreams.

• Experience working independently in a lean, fast-paced matrix, collaborating closely with senior and cross-functional partners.

• Scientifically rigorous, detail-oriented, and comfortable with ambiguity.

• Experience navigating structured Phase 3 processes and individualized expanded access decisions.

• Patient-centered and mindful of Angelman syndrome and expanded access realities.

• Articulate and effective communicator across written and verbal channels.

• Schedule adaptability for urgent participant medical and safety matters and cross-time-zone collaboration.

The specific statements shown in each section of this description are not intended to be all-inclusive. They represent typical elements and criteria necessary to successfully perform this position.

To apply please send your resume to careers@oakhillbio.com