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!

 

BIOMARKER OPERATIONS LEAD - ASSISTANT DIRECTOR

 

SUMMARY:

We are seeking a highly motivated and outstanding individual to join our Biomarker group as the Biomarker Operations Lead. This is a new team, and this position will be responsible for its direction and management. S/he will be responsible for establishing the department objectives and needs; and oversight of the implementation and optimization of processes to work in a cross functional matrix. S/he will manage personnel to lead and coordinate the operational clinical biomarker activities and deliverables to ensure they are aligned within and across program needs. S/he will be responsible for both performing and managing personnel to execute biomarker operations within multiple assigned programs and will support CRO placement, oversight, and contract negotiation and implementation. The candidate must have prior scientific experience to support biomarker regulatory and operational strategy.

RESPONSIBILITIES: 

Direct and execute biomarker operations with excellence. Responsibilities will include:

Establishing department direction and objectives  Manage resource allocation and forecasting for current and future programs Present in internal forums the department direction, and short- and long-term goals to strive for excellence in execution of biomarker operations Communicate effectively and efficiently with team members and senior management regarding department updates on project status, timelines, milestones, key events, and changes to the development plan and implications Manage and mentor Biomarker Operations team member(s); provide guidance, training, and support to foster professional growth and excellence in performance  Work directly on multiple programs in parallel, and oversight of personnel supporting additional clinical programs  At the program level, specific tasks will include Review of clinical documents including study protocols, LSA, QRC, and any other study related documentation pertaining to sample collection and storage Managing sample transport to and analysis at CROs, and supporting demographics reconciliation, to ensure timely delivery of high-quality biomarker data to meet program deliverables  Contribute to applicable bioanalytical sections of CSRs, IND/NDA summary documents, and other regulatory submissions.  Represent biomarkers in operational meetings and research meetings which includes being readily available to advise on biomarker or study related updates and questions

REQUIREMENTS:

Candidate should have experience in managing operations for clinical trials, with a minimum of 8 years of related experience with a bachelor’s degree, or 6 years with a master’s degree; or a PhD with 3 years’ experience; or equivalent experience  Excellent communicator who is comfortable leading large, cross functional meetings and maintaining open and effective lines of dialogue, address problems and collaborate constructively with team members, external vendors as well as senior management Must be organized, adaptive, and detail oriented, with the ability to multitask, and manage multiple programs in parallel with competing priorities  Proven ability of being productive and successful in an intense work environment  Experience in life science research, with a basic understanding of mechanism of action of disease. Experience in managing personnel is highly preferred  Candidate can be located in San Diego or be fully remote  Travel minimal 0-10%

 

Please visit our website, www.ionis.com for more information about Ionis and to apply for this position; reference requisition #IONIS003229

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%20Applicants%C2%A0%C2%BB-,Benefits,-Employees%20are%20rewarded

The pay scale for this position is $127,915 to $150,000

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

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