Director/Executive Director - Clinical Development

Ionis Pharmaceuticals Carlsbad , CA 92008

Posted 1 week ago

Ionis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 and was purposely designed to create a better, more efficient drug discovery platform, establish a new innovation-centered business model, and maximize the value of every medicine created and get it to the people who need it most as quickly and as efficiently as possible.

With the RNA molecule as the basis of our novel drug discovery platform, we are targeting an unprecedented range of therapeutic areas. Our antisense therapies are disrupting diseases and changing their coursefrom the rarest of conditions, to those that impact millions of people. We currently have three commercial products and more than 40 potentially transformative medicines in our pipeline designed to treat a broad range of diseases.

Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our success is a direct result of our outstanding employees. We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career.

Director/Executive Director Clinical Development

The Director/Executive Director, Clinical Development reports to the VP Development and Franchise Head, CardioMetabolic Disorders. This is a high profile role and the successful candidate will provide strategic leadership within the therapeutic area franchise and clinical leadership to one or more Clinical Project Teams to ensure the successful design and implementation of Clinical Development Plans. Major areas of responsibility include strategic leadership in the assigned therapeutic area(s), design and ownership of the clinical development plan, KOL liaison and management, clinical trial design, medical monitoring of Ionis-sponsored clinical trials (if medically qualified), clinical data analysis, internal and external communication of project information and plans, and contributions to regulatory submissions, publications and presentations.

RESPONSIBILITIES:

  • Developing, and keeping current, the clinical development plan/s

  • Design of clinical trials and writing/review of protocols and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports etc.)

  • Making critical strategic decisions

  • Leading action-oriented, project team meetings and periodic project reviews including setting appropriate agendas and approving actionable minutes

  • Identifying emerging risks and managing them with the Project Manager

  • Acting as Medical Monitor for Ionis-sponsored clinical trials (if medically qualified)

  • 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

  • Maintaining medical/scientific standards, educating team members and managing the Scientific Advisory Board (SAB) as needed

  • Involvement in management (and other oversight) committee meetings, including Development Management Committee (DMC) and Research Management Committee (RMC)

  • Interacting with regulatory agencies, in concert with the Regulatory Affairs Department

  • Representing project(s) to corporate partners, investors and clinical investigators as required

  • Developing external advocates for the company's technology, products and direction

  • Facilitate the effective conduct of clinical trials by:

  • Developing and maintaining excellent working relationships with investigators

  • Ensuring that all GCP requirements are consistently met.

  • Delivering high quality scientific presentations on company technology, investigational agents and/or clinical study issues to investigators and clinical site staff

  • Providing guidance and/or training for external personnel/parties involved in Ionis' clinical studies

  • Performing clinical study data review and analyses in conjunction with Biometrics

  • 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 by 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

REQUIREMENTS:

  • M.D. preferred; Pharm D will be considered

  • 5+ years of Clinical Research experience obtained in the Pharmaceutical Industry and excellent knowledge of the drug development process

  • Experience of conducting clinical trials in metabolic/endocrine areas, NASH and nephrology experience in conducting clinical studies a plus

  • Comprehensive and detailed experience of clinical trial design, implementation and sponsor/site interactions in conduct of clinical trials

  • Must have experience of working in a leadership role within the development project team e.g. member of a core project team, sub-team leader, etc.

  • Proven proficiencies with a wide range of data/information: scientific/clinical, legal/regulatory, business, financial and market analytics

  • Strong communication skills (including writing and presentation skills) with success in influencing all levels cross functionally

  • Proven leadership abilities in a highly complex and fast paced environment where negotiation skills were essential for success

  • Experience working with corporate partners would be an advantage

  • An ability to be productive and successful in an intense work environment

Excellent salary and benefits package offered.

Please visit our website, www.ionispharma.com, for more information about Ionis and to apply for this position; reference requisition #DIREC01598.

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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


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Director/Executive Director - Clinical Development

Ionis Pharmaceuticals