DIRECTOR, CLINICAL DEVELOPMENT

Summary

Provide clinical leadership and involvement in one or more Clinical Project Teams to ensure the successful design and implementation of Clinical Development Plans. Major areas of responsibility include clinical trial design (for future programs), planning and strategic execution of ongoing Ionis-sponsored clinical trials, clinical data analysis, communication of project information and plans, and contributions to regulatory submissions, publications including the CSR and presentations. This position can be fully onsite, remote or hybrid. For remote working, the expectation includes visits to Carlsbad, CA (HQ) with an approximate quarterly cadence.

This position will focus on the neurology therapeutic area, including Alexander disease.

Responsibilities

• Facilitating the conduct of clinical trials by:
  • Developing and maintaining excellent working relationships with internal cross-functional team to function as the Clinical Development lead for an ongoing Phase 3 clinical trial
  • Reviewing clinical study data
  • Delivering high quality and succinct scientific presentations on company technology, investigational agents and/or clinical study issues internally, to investigators and clinical site teams
  • Working with patient advocacy groups and other groups on natural history and biomarker studies to fill gaps in clinical development pathways
  • Interacting with regulatory agencies, in concert with the Regulatory Affairs Department and Project Team Lead, to develop novel and efficient clinical programs in rare neurological diseases without clearly defined developmental pathways
  • Designing or assisting with design of clinical trials and contribute to the writing/review of protocols and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, etc.)
  • Interacting with external medical/scientific advisors, thought leaders and clinical investigators in the therapeutic area and with internal management and drug development staff to prepare/revise/maintain and efficiently execute the drug development plan
  • Leading action-oriented project team meetings and periodic project reviews
  • Identifying emerging risks from ongoing clinical trials, aligning with the cross-functional team and managing them in concert with the team, as appropriate
  • Developing and overseeing the Clinical Development budget for the project
  • Providing clinical education support for internal company team members
  • Facilitating, assisting and/or participating in the preparation of clinical study manuscripts by Investigators, internal personnel, and/or contract writers
  • Maintaining clinical and technical expertise in the therapeutic area; reviewing scientific journals, attending scientific and key technical meetings and partnering with company medical, research and commercial teams
  • Assisting in accomplishing department and corporate objectives
  • Other duties as assigned

Competencies Identified For Success

• Demonstrated and capable leadership of a cross-functional team with ability to align the cross-functional team and assume accountability for team decisions and plans.
• Elevated interpersonal and communication skills with ability to flexibly relate to both internal and external stakeholders.
• Ability to develop strong positive relationships with colleagues in across functional areas and with senior management.
• Desire to build a world-class competency-based organization through a combination of vision, energy, drive, enthusiasm and flexibility/adaptability
• It is imperative that this individual operate successfully both at a strategic level as well as in an operational, hands-on capacity in tight coordination with Clinical Operations within the team structure of Ionis. The latter requires a self-motivated, practical, can-do and time-conscious approach that is motivated by the need to do the things today that strategic plans indicate will get a transformative treatment to patients in the future in rare disease setting with limited or no developmental pathway precedent.
• Proactive critical thinking skills to analyze complex issues to weigh risks, develop relevant and realistic plans, programs and recommendations in a developmental program in rare neurologic disease with little or no developmental pathway precedent
• Ability to thrive in a very fast-paced, innovative environment on complex programs while remaining flexible, proactive, resourceful and getting work done efficiently
• Attention to detail and quality while also being aware of the need to make timely decisions and to execute

Requirements

An MD, PharmD and/or PhD with 8 years of strong leadership skills and proven biopharmaceutical industry experience in leading clinical development for late-stage therapeutic programs, with experience in rare diseases, pediatrics and/or neurology strongly preferred. A thorough understanding of the full range of preclinical and clinical development processes would constitute a good fit for this role. A scientific background in addition to medical or PhD training, with focus in the fields of rare disease and/or neurology is strongly preferred. A demonstrated and interrogable record of strategic development planning, leadership and decision-making resulting in successful outcomes is expected. A record of accomplishment including leading the design, planning and execution of Phase 3 clinical studies through data read out and filing is also highly desirable. Excellent writing skills with ability to communicate succinctly and provide necessary level of detail for audience and scope of communication.

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003638

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded

The pay scale for this position is $231,289 to $305,100

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.