Position Summary

This position will report to the Chief Operations Officer and is expected to interact extensively with the whole executive team and leaders of the organization.

The Head of Clinical Development, will be a key leader supporting strategy and operational implementation of clinical activities and development of Rakuten Medical’s clinical assets. The Head of Clinical Development will directly lead and manage the teams involved in Clinical Sciences, Clinical Operations, Biometrics/Data Management, and will collaborate extensively with the Medical Directors in a matrix organization, to support all the clinical execution of programs at Rakuten Medical.

This position will involve extensive coordination with the top leaders of the organization including the CEO, the COO, the CTO, heads of quality, medical affairs, regulatory etc, as well as the Rakuten Medical’s Clinical Operations Team, Medical Directors, Clinical Scientists, Biostatistics, Clinical Pharmacology, Regulatory Affairs and Quality Assurance and external CROs. This position will form a tight alliance with Program Management at Rakuten Medical to integrate resources, to align operational activities between functions, to maximize efficiency, cut costs of execution and meet timelines.

Day-to-day responsibilities will include direct oversight of operations and personnel involved in clinical sciences, clinical trial operations, biometrics/data management, and will involve day-to-day interactions with CROs, medical teams and supporting functions such as regulatory, translational sciences etc.

The position will be a key participant of Development SubTeams, with subject matter experts from key functions, such as Pre-Clinical R&D, Regulatory Affairs, Medical Affairs, Biostatistics/Data Management, Pharmacovigilance, Quality Assurance, Business Development, and Commercial Operations. This individual will provide clinical expertise and strategic insights to develop a life-cycle strategy and evaluation of new programs to be prioritized or advanced into clinical development.

The position will collaborate with the commercial team to develop a commercialization strategy which will include development of TPPs based on competitive assessment and target positioning, and will align the clinical development strategy with the commercial strategy.

Key Duties and Responsibilities

Essential job functions are the fundamental duties of a position: the things a person holding the job absolutely must be able to do with or without reasonable accommodation in accordance with the Americans with Disabilities Act.

• Lead the expansion of internal clinical capacity and manage/lead the clinical team and clinical trial execution at Rakuten Medical to support current and future clinical trials from Phase 1 to NDA/BLA submissions.
• Direct oversight of operations and personnel involved in clinical sciences, clinical trial operations, biometrics/data management.
• 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.
• 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 key external spokesperson of the clinical programs in interactions with development partners, investigator meetings, and advisory boards.
• Other duties as assigned.

Desired Education, Skills and Experience

• MD degree. Oncology board certification preferred but not required.
• 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 Hand Subpart
• 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.
• 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.
• High emotional intelligence, sound temperament, and professional attitude.
• Ability to interact with functional teams across the organization and promote a culture without silos.
• Outstanding leadership and management capabilities to build, motivate and manage a strong operational organization and serve a leader for the entire corporation.
• Personal alignment with Rakuten Medical’s values, mission and vision.
• Broad business perspective to integrate clinical concepts as part of the overall corporate strategy.
  
  

The expected salary range for this position based in California is $220,000 to $300,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.

We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.

Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.