Director / Executive Director, Clinical Development Cardiovascular

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.  With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know our success is a direct result of the exceptional talent and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money, and energy into making our onsite and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We are building on our rich history, and believe our greatest achievements are ahead of us.  We invite you to apply and join us if you’re passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization.  Experience and contribute to our unique culture while you develop and expand your career!

DIRECTOR/EXECUTIVE DIRECTOR - CLINICAL DEVELOPMENT CARDIOVASCULAR

The Director/Executive Director provides clinical development leadership to more than one project teams to ensure the successful design and execution of clinical development plans.  Major areas of responsibility include overall development plan design, clinical trial design and execution of Ionis-sponsored clinical trials, clinical data analysis, communication of project information and plans, and contributions to regulatory submissions, publications and presentations. This position will focus in the cardiovascular therapeutic areas.

RESPONSIBILITIES:

• Design clinical development plans; serve as program lead in internal and external interactions, championing programs and positioning them for success
• Acting as a Medical Monitor for Ionis-sponsored clinical trials (if medically qualified)
• Interact with regulatory agencies, in concert with the Regulatory Affairs Department, to develop novel and efficient clinical programs in both rare and common disease populations
• Design clinical trials and contribute to development of protocols and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, etc.)
• Establish external medical/scientific advisory teams and interact with thought leaders and clinical investigators in the therapeutic area to prepare/revise/maintain and efficiently execute the drug development plan
• Lead action-oriented project team meetings and periodic project reviews including setting appropriate agendas and approving actionable minutes
• Lead, manage the performance of, and develop, direct reports
• Identify emerging risks and manage them with the team as appropriate
• Develop and oversee the project budget with the Project Manager and Development Controller
• Facilitate the conduct of clinical trials by:
  • Developing and maintaining excellent working relationships with investigators
  • 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
  • Reviewing clinical study data and performing analyses in conjunction with Biometrics
• Mentor the project team, including any clinical scientists and project team leaders directly or indirectly reporting to this position, and provide clinical education support for internal company customers
• Facilitate and participate in the preparation of clinical study manuscripts with Investigators, internal personnel, and/or contract writers
• Maintain clinical and technical expertise in the therapeutic area; review scientific journals, attend scientific and key technical meetings and partner with company medical, research and commercial teams
• Assist in accomplishing department and corporate objectives
• Other duties as assigned

REQUIREMENTS:

• • MD and/or Ph.D. with strong leadership skills and proven biopharmaceutical industry experience in leading clinical development for early- and mid-stage therapeutic programs. 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 cardiology, with phase 3 experience preferable.
  • Background and experience in development of heart failure drugs would be desirable.
  • Demonstrated record of strategic development planning, leadership and decision-making resulting in successful outcomes is expected.
  • Demonstrated record of designing, planning and executing clinical studies is expected.
  • 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 Development, Research and senior management.
  • Experience providing leadership and guidance to project teams
  • It is imperative that this individual operate successfully both at a strategic level as well as in an operational, hands-on capacity. The latter requires a 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.
  • Ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and getting work done efficiently
  • A proactive ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations
  •  Attention to detail and quality while also being aware of the need to make timely decisions and to execute

Please visit our website, http://www.ionis.com, for more information about Ionis and to apply for this position; reference requisition #IONIS003435

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=to Applicants »-,Benefits,-Employees are rewarded

The pay scale for this position is $233,294 to $375,000

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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

Salary : $233,294 - $375,000