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Alpha-9 Oncology · 17 hours ago

Senior Director, Clinical Development

Boston, MA

Full-time

Hybrid

Lead/Staff, Director/Executive

5+ years exp

Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. The Senior Director of Clinical Development will provide direction and technical leadership in the development and execution of clinical development plans for drug candidates, ensuring clinical trials are conducted according to good clinical practice and regulatory requirements.

BiotechnologyMedicalProduct Research

Hiring Manager

Brendan Grosse

Responsibilities

Design and direct Phase 0-3 clinical trials for radioligand therapy compounds

Author and/or collaborate with clinical and other teams to create documents such as Study Concepts/Synopses, Protocols, ICFs, Investigator Brochures, INDs, NDAs, Briefing Documents, abstracts, manuscripts and provide medical and scientific input into the development of deliverables required for study activation, conduct, and closure (CRFs, SAP, Data Listings, CSRs, etc.)

Review, interpret, and communicate strategy, progress, and emerging data of ongoing research projects within and outside the organization

Ensure clinical trials are conducted according to good clinical practice and all applicable regulatory requirements, standard operating procedures, and other quality standards

Responsible for collaborating and driving implementation of the clinical program through cross-functional teams; completing studies on time and within budget

Contribute to and optimize an effective KOL and investigator communication strategy. Interact with investigators as warranted to obtain necessary information before, during and after the study

Organize and present at KOL advisory board and investigator meetings

Provide medical review, analysis and medical guidance during the case handling and reporting process for Adverse Event and Adverse Reaction reports received for the Company’s investigational products

Plan, oversee and direct risk management activities for investigational compounds

Respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans

Monitor and keep current on industry best practices, pharmacovigilance and changes in global safety regulations and guidelines

Train/mentor colleagues, CRO and study site staff on the therapeutic area, molecule, and clinical documents as appropriate

Working with other departments, create functional policies and procedures to provide strong and efficient clinical development processes that are appropriate for a matrixed environment

Support product lifecycle management for new indications as requested

Qualification

Clinical development experienceNuclear medicine expertiseOncology expertiseClinical research regulationsScientific acumenProject management skillsAnalytical abilitiesRisk managementEffective communicationLeadership skills

Required

MD, DO, or equivalent ex-US medical degree with 5+ years of clinical development experience, including at least 3 years in the pharmaceutical/biotech industry or as a clinical trial investigator, with experience managing radiopharmaceutical clinical trial programs

Expertise in nuclear medicine and/or oncology highly desired

Comprehensive understanding of clinical research regulations, including GCP, ICH guidelines, and other US and international requirements

Superior planning and project management skills, including risk assessment and contingency planning, with the ability to manage multiple projects simultaneously

Strong scientific acumen, analytical abilities, and sound clinical judgment, demonstrating credibility and integrity consistent with the company's values

Effective communicator with the ability to present ideas and document complex medical/clinical concepts clearly in both written and oral form

Decisive and collaborative leader, capable of working independently and as a respected team member

Comfortable working in a small, resource-constrained start-up environment

Ability to travel as required (up to 25%)