Senior Director, Clinical Development

Alpha-9 Oncology • Boston, MA

81d

About The Position

The Senior Director of Clinical Development will provide direction and technical leadership in the development and execution of clinical development plans for drug candidates and contribute to the Clinical Development strategy. The ideal candidate will have a track record of designing and executing robust clinical studies, leadership in providing expert input in scientific discussions and proactive engagement in interactions with thought leaders, health authorities, regulatory bodies and experience working with CROs. In this role, the ideal candidate's guidance and learning throughout the planning and implementation phases will ensure clinical development timelines are met across the organization. The Senior Director of Clinical Development will report to the Chief Medical Officer (CMO).

Requirements

• 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%).

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.

Benefits

• Competitive salary
• Bonus
• Equity
• 20 vacation days
• 5 sick days
• Technology allowance
• Commuter reimbursement
• Generous retirement savings plans with employer matching
• Extended health benefits
• Paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: No Education Listed