Position Summary

• Lead the expansion of internal clinical capacity and manage/lead the clinical team and clinical trial execution at Aspyrian to support current and future clinical trials from Phase 1 to NDA/BLA submissions.
• Implement best practices and standards for trial management in collaboration with other members of the clinical operations team.
• Develop and oversee clinical timelines, budget forecasts, budget tracking, and budget review. Will be accountable for achievement of trial timelines within budget.
• Work in close collaboration and lead the clinical operations personnel, who will provide oversight of clinical trials regarding operational aspects.
• Define the clinical actions, assign clinical resources, clinical budget, monitor project status, identify risks of clinical execution. Work with Program Management to assure deep integration of objectives, achievement of milestones according to the timelines, and optimal use of resources across functions.
• Will work with Data Management, Pharmacovigilance, Medical Directors and Medical Affairs to coordinate real time availability of clinical trial data, assuring data integrity, including safety, efficacy, pharmacokinetic, and correlative studies data to provide consolidated information for trial progress.
• Review statements of work, master service agreements, and quality agreements as relates to clinical programs.
• Collaborate with the Pharmacovigilance and Medical Directors and be jointly responsible with the CMO, Pharmacovigilance, Medical Directors and Medical Affairs for the clinical safety, pharmacovigilance and medical monitoring activities of clinical trials and post-marketing responsibilities.
• Ultimate responsibility for clinical development plans, clinical trial protocols, clinical pharmacology, data analyses, clinical study reports, and other related clinical documents.
• Ensure with QA that all company clinical trials are conducted according to GCP and all applicable regulatory requirements, with a focus on the safety and medical monitoring aspects of the trials.
• Will support and will be accountable for clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/BLA submission documents, responses to Health Authorities questions.
• Partner with the Clinical Teams, Translational Research, Medical Affairs, Regulatory, Pharmacovigilance, Data Management, Quality and Commercial teams to identify and address key questions related with clinical development.
• Key Contributor to the medical/scientific input for multi-disciplinary team activities including SubTeams that are involved in life-cycle management and program prioritization.
• Collaborate with Medical Affairs and Commercial Teams to develop a strong group of Key Opinion Leaders.
• Development of publication plan and directly oversee timely clinical data communication.
• Serve as a external spokesperson of the clinical programs in interactions with development partners, investigator meetings, and advisory boards.
• Other duties as assigned.

• MD or PhD degree. Oncology board certification preferred.
• At least 10 years of clinical development leadership experience in oncology within biopharmaceutical, companies, including drug and device clinical development. At least 5 years within a similar role as listed in this job description.
• Excellent working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development. Experience in representing the sponsor in front of regulatory agencies
• Demonstrate experience in clinical design and implementation of Phase 1 to Pivotal Clinical studies in oncology, with evidence direct leadership of trials that meet the timelines, budget, expected outcomes and lead to regulatory success of innovative medicines.
• Direct experience in clinical development of biologics and small molecules.
• Knowledge of statistical concepts as they relate to clinical plans.
• Knowledge of clinical pharmacology.
• Knowledge of adaptive trials and design of trial to support accelerated approval under accelerated and Restricted Approvals Under Subpart H and Subpart E.
• Experience managing clinical CROs from RFP to statements of work to coordinating execution
• Knowledge of the day-to-day medical monitoring of clinical trials (e.g., responding to questions about patient eligibility and protocol waivers; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives; and IND expedited safety reports).
• Knowledge in pharmacovigilance, including the receipt and processing of ADRs, completion of MedWatch forms, and generation of Periodic Safety Update Reports.
• Strong communication and collaboration skills. Ideal candidate will have a network of external thought leaders within oncology, who serve as advisers.
• Broad and updated understanding of the industry status and upcoming innovation in clinical and molecular oncology.
• High emotional intelligence, sound temperament, and professional attitude.
• Outstanding leadership and management capabilities to build, motivate and manage a strong operational organization.
• Personal alignment with Aspyrian's values, mission and vision.
• Broad business perspective to integrate clinical concepts as part of the overall corporate strategy.
• Excellent organizational skills and ability to meet deadlines.
• Ability to see the big picture and pay attention to details.
• Hands-on, action oriented. Proactive in anticipating and addressing difficulties.
• Willing to travel to support clinical and corporate activities.