Clinical Development Scientist

ARTBIO; Cambridge (MA); Presencial; USD 180.000 - 260.000; Tempo integral

Benefícios oferecidos por esta vaga

Competitive compensation and benefits

Hands-on training and professional dev

International, collaborative culture

Resumo da vaga

ARTBIO is seeking a Clinical Development Scientist to serve as the day-to-day clinical lead for an RLT oncology program. You will design protocols, chair the study team, drive timelines, and translate clinical data into decisions to advance the asset.

You will own safety review, data management, and regulatory contributions, while coordinating with Clinical Operations, Finance, and external partners in a fast-paced biotech setting.

Qualificações

• Advanced degree in life sciences, pharmacy, medicine or a closely related discipline.
• Minimum 4 years of clinical development experience with hands-on oncology study responsibility.
• Demonstrated protocol authoring from concept through approval.
• Hands-on clinical data review and data-package preparation for safety or dose-escalation committees.
• Experience with early-phase oncology trial design including dose escalation and cohort expansion.
• Ability to read and interrogate imaging, dosimetry, pharmacokinetic and biomarker data.

Responsabilidades

• Design and author clinical study protocols and informed consent forms.
• Chair study team meetings and drive decisions to closure.
• Manage study budget and forecast with Clinical Operations and Finance.
• Oversee ongoing clinical data review and safety data packages.
• Support regulatory content for IND/CTA submissions and DSURs.
• Engage sites, vendors and investigators and manage external relationships.

Conhecimentos

Protocol authoring

Clinical data review

Early-phase oncology trial design

Imaging/dosimetry data interpretation

Cross-functional collaboration

Budget & forecast management

Study team facilitation

Formação

Advanced degree (MSc/PhD/PharmD/MD) in life sciences or related

Descrição da vaga

Summary

We are seeking a Clinical Development Scientist to act as the day-to-day clinical lead for one of ARTBIO’s Radioligand Therapy (RLT) development programs, combining scientific ownership of the study with hands‑on project management of its execution. Reporting to the VP, Clinical Development and working closely with functional heads and subject matter experts, you will be the person who holds the program together: designing and authoring the protocol, chairing the study team, driving the timeline, and turning emerging clinical data into the decisions that advance the asset.

Responsibilities

Clinical development strategy and study design

• Contribute to the clinical development plan for the assigned asset, including dose-escalation strategy, cohort design and endpoint selection.

• Author clinical study protocols, amendments and informed consent forms, and coordinate cross-functional review to approval.

• Translate preclinical, dosimetry and emerging clinical data into study design.

Program and project management

• Serve as the day‑to‑day clinical lead and primary point of contact for the assigned asset across all functions.

• Chair or co-chair study team meetings: set the agenda, drive decisions to closure, and track actions to completion.

• Manage study budget and forecast in partnership with Clinical Operations and Finance.

Data, safety and decision-making

• Own ongoing clinical data review and scientific data cleaning in partnership with the Medical Monitor and data management.

• Prepare and run Safety Review Committee and dose‑escalation meetings, including data packages, dose recommendations, minutes and follow‑through.

• Support safety surveillance, SAE reconciliation and signal evaluation.

• Contribute to statistical analysis plans and review of outputs.

• Prepare clinical data and interpretation for internal governance, investor and partner interactions.

Regulatory and documentation

• Contribute clinical content to IND/CTA submissions, Investigator's Brochures, DSURs, briefing books and responses to health authority questions.

• Contribute to clinical study reports and ensure the clinical narrative is supported by the data.

Sites, vendors and external engagement

• Support site feasibility, selection and activation.

• Deliver protocol training at site initiation visits and investigator meetings and act as the clinical point of escalation for protocol questions.

• Build relationships with investigators, steering committee members and advisory boards.

• Contribute to abstracts, posters, manuscripts and congress presentations.

Qualifications & Education

• Advanced degree (MSc, PhD, PharmD, MD or equivalent) in life sciences, pharmacy, medicine or a closely related discipline.

• Minimum 4 years of clinical development experience for appointment. Experience may be gained in industry or at a CRO and must include hands‑on responsibility for at least one oncology study.

• Demonstrated protocol authoring, including at least one protocol taken from concept through to approval.

• Hands‑on experience of clinical data review, query resolution, and preparation of data packages for safety or dose‑escalation committees.

• Experience with early‑phase oncology trial design, including dose escalation, DLT definition and cohort expansion.

• Ability to read and interrogate imaging, dosimetry, pharmacokinetic and biomarker data.

Preferred

• Direct experience with radiopharmaceutical oncologic therapies.

• Experience with prostate cancer therapies and landscape.

• Experience of studies conducted in both the US, Australia and Europe.

Personal Attributes

• Comfortable working in a fast‑paced biotech environment, hands on and self‑directed.

• Team player who thrives on collaboration and cross‑functional flexibility.

• Detail‑oriented without losing sight of the program as a whole.

• Commitment to safety, quality, continuous improvement and staying current with industry trends and advances.

What We Offer

• A unique chance to contribute to first‑in‑class cancer therapies.

• Exposure to both imaging and clinical development in a dynamic biotech setting.

• Hands‑on training and professional development opportunities.

• An international, collaborative, and supportive work culture.

• Competitive compensation and benefits.

About Us

Channeling Energy. Changing Lives. ARTBIO redefines cancer care by discovering and developing a new class of Alpha Radioligand Therapies (ARTs), powered by unique Pb-212 isotope technology and seamless supply. Our team works tirelessly to bring therapies that matter to patients who need them.

The unique ARTBIO approach selects the optimal alpha‑precursor isotope (212Pb) and tumor‑specific targets to create therapeutics with the potential for the highest efficacy and safety. The company's AlphaDirect™ technology, a first‑of‑its‑kind 212Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs, with lead program AB001 currently in first‑in‑human trials. The company is shaped by a long‑standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway’s Radium Hospital.

Cancer is relentless. So are we. We are driven by a desire to do better for cancer patients, lowering the burden of toleration and safety while at the same time raising the bar on clinical efficacy and duration. As an emerging, global biotech with locations in Boston, Basel, London, and Oslo, we take advantage of diverse scientific depth and insights, which makes ARTBIO a unique place to work.

EEO Statement

ARTBIO is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.