Study Design and Execution

• Provide scientific input into protocol development and study design, ensuring robustness, feasibility, and alignment with CDP-defined objectives and regulatory requirements
• Author or co-author key study documents (e.g., Clinical Study Proposals), contributing to preparation and presentation at governance forums such as Protocol Review Boards
• Support study conduct by addressing scientific questions, ensuring data integrity, and maintaining alignment with protocol and regulatory standards
• Provide scientific input into study-level decisions related to protocol implementation and study conduct, within the strategic framework defined by the CDL
• Present and support the scientific rationale and study design at Investigator Meetings and respond to scientific inquiries from study sites
• Support implementation of study-level Go/No-Go criteria aligned to the asset-level decision framework defined by the CDL

Data Generation, Analysis, and Interpretation

• Analyse and interpret clinical data to generate insights on safety, efficacy, and patient populations
• Integrate data from internal and external sources (e.g., literature, competitor data, emerging science) to inform study and programme understanding
• Provide scientific input into data review and interpretation activities, in collaboration with Medical Directors and pharmacovigilance
• Translate study findings into clear scientific insights to inform programme progression and support CDL-led decision-making

Clinical and Regulatory Deliverables

• Contribute to development of clinical and regulatory documents, including protocols, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and submission materials
• Ensure scientific accuracy, consistency, and quality across study documentation
• Support preparation of regulatory submissions and responses to Health Authority queries
• Contribute to regulatory reporting requirements (e.g., DSURs, INDSRs) and ensure alignment with regulatory standards

Cross-Functional Collaboration & Scientific Contribution

• Serve as an extended member of the CMT, partnering with Clinical Operations, Statistics, Safety, Regulatory, and Medical Affairs to support integrated study delivery
• Provide scientific expertise to cross-functional discussions, including integrated evidence planning and disease-area forums, as appropriate
• Participate in internal and external scientific interactions with investigators, Key External Experts, advisory boards, and collaborators
• Contribute to scientific communications, including publications, congress presentations, and study-related materials

Ways of Working & Continuous Improvement

• Identify scientific and operational risks at the study level and provide input into mitigation strategies
• Support and drive implementation of consistent ways of working and process improvements across the programme
• Participate in Oncology Clinical Development initiatives and workstreams to strengthen standards, processes, and capabilities
• Engage in ongoing development to deepen scientific expertise, expand disease-area knowledge, and build broader clinical development capabilities

Basic Qualifications:

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor’s degree in life sciences or related discipline required
• 5+ years of experience in pharmaceutical/biotechnology industry or related clinical development experience, with a focus on oncology.
• Experience and understanding of clinical development from early stage through to regulatory submission, including study design, protocol authoring, and data review/interpretation.
• In-depth knowledge of GCP, ICH, and global regulatory guidelines.
• Experience authoring or contributing to clinical study proposals, protocols, Investigator’s Brochures, informed consent forms, clinical study reports, and regulatory submissions.
• Demonstrated ability to operate effectively within cross-functional matrix teams and contribute to clinical decision-making.
• Proven track record of working with investigators, site staff, external experts, CROs, and vendors.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Advanced degree (e.g. MS, PhD, PharmD) strongly preferred in life sciences or a related discipline
• Clinical development experience across multiple phases of development (Phase I–IV)
• Oncology or immuno-oncology clinical development experience.
• Experience presenting or preparing materials for Protocol Review Boards, governance meetings, or scientific forums.
• Knowledge of regulatory requirements to support registration, including experience contributing to IND, EoP2, scientific advice, pre-NDA/BLA, NDA/MAA, or AdCom submissions.

Skills

Analytical Thinking, Clinical Data Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $189,750 to $316,250.
• If you are based in another US location, the annual base salary range is $189,750 to $316,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Polish Salary Range / Polski przedział wynagrodzenia: PLN 472,500 to PLN 787,500

The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate