Development Scientists

As the Development Scientist you will join a diverse and agile team and contribute to the development of clinical strategies for assigned modalities or indications within the division. This position will work closely with the Global Medical Lead (GML), Operations Lead, and Development Physician, and is accountable for the design, implementation, monitoring, and analysis of clinical studies conducted within the assigned program. Development Scientists are expected to perform their responsibilities independently and have core knowledge of clinical development to enable increased participation in division and portfolio level initiatives.

Responsibilities

• Responsible and accountable for activities related to all current and planned clinical trials (e.g., develop protocols, investigator brochures, CRFs, informed consents, and clinical study reports and review of clinical trial documents, study analyses, and reporting) on assigned development programs.
• Provide expertise to cross-functional team members to synthesize/contextualize data to facilitate discussion and timely decision making.
• Serve on the clinical sub-team with the GML, Operations Lead, and Medical Monitor/Development Physician and support preparation of clinical development plans, site identification and management, and DESC meetings.
• Under the guidance of development physician/GML, perform medical monitoring activities (review, analyze and triage patient data, generating reports).
• Able to independently lead working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.
• Partner with GML in preparing for Health Authority (HA) Meetings and assist in addressing HA inquiries.
• Prepare analysis for DMC/DSMB/DEC forums or regulatory submissions together with the GML and Product Responsible Person.
• Provide training at investigator meetings and site initiation visits with clinical trial staff, and partner with Clinical Operations and Medical Affairs to enable appropriate enrollment into the clinical studies or registries.
• Collaborate cross-functionally to create, review, and/or present clinical slides for internal meetings and external forums.
• Support engagement with potential and current sites (e.g. SIVs, investigator meetings, conferences, steering committee, advisory board meetings).
• Exhibit expertise related to Study Data Review and Analysis, and provide clinical input into statistical planning, data analysis and interpretation.
• Provide clinical leadership and support for publication of data (manuscripts, presentations) and disease or technology related scientific publications.
• Work closely with operations group for site and vendor feasibility, trial set up and monitoring.
• May lead the execution of contracts, particularly for investigator meetings and advisories.
• Support efforts to develop strategic partnerships with Key External Experts (KEEs).
• May represent development and assist with clinical assessment for due diligence of new assets for potential in-licensing and acquisition.
• Support strategic initiatives related to assigned molecule(s), CDP, therapeutic area(s), or portfolio, if requested.
• Performs other duties as assigned or special projects as needed.

Qualifications and Experience

• Proven experience and core knowledge of clinical development to enable increased participation in division and portfolio level initiatives.
• Independently led working groups and/or sub-team initiatives in support of protocol, disease area, or clinical development plan.
• Thorough knowledge and demonstrated expertise in biotechnology/pharmaceutical industry related to clinical drug development (early-stage development through approval) from initial study design, study execution and regulatory submissions (INDs, BLAs, NDAs) with global regulatory agencies.
• Experience in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications and/or relevant accreditations).
• Strong computer skills including MS Office Suite and industry-standard software (e.g., electronic data capture systems) and data analysis software (Excel, SigmaPlot, SPSS, R, etc.).
• Strong collaboration and interpersonal communication skills; able to interact with all levels of internal stakeholders and key functional areas including Regulatory Affairs, Medical Affairs, Clinical Operations, Data Sciences, Research, Translational Science and Pharmacovigilance.
• Demonstrated success working with key external stakeholders (e.g., KEEs, investigators, researchers) including presenting/responding to health authorities.
• Knowledge of global pharmacovigilance standards and guidance documents.
• Comfortable working in a flexible, dynamically changing and (at times) challenging environment.
• Excellent strategic planning, organizational and verbal and written communication skills.
• Aware of cultural diversity and how to influence and manage in a multi-cultural organization.
• Highest level of scientific integrity and impeccable work ethics.

Education and Preferred Qualifications

• Ph.D. or PharmD degree, or other relevant Master’s degree.
• Advanced degree in a relevant scientific discipline; health science or clinical discipline with extensive clinical, scientific/research, pathology or industry related experience or combination of academia and industry.
• Extensive experience in solid tumours (lung, colorectal, pancreatic cancers), biologics or immuno-oncology.

Location, Travel and Working Model

• This is a hybrid, permanent full-time position based in the UK. Role requires a blend of home and a minimum of 1 day per quarter in the local office. Some flexibility may be required in line with business needs.
• Be able to travel approximately 25%, with international travel at times.