Vice President, Clinical Development - Somerville, United States - Akebia Therapeutics

Description

Clinical > Clinical DevelopmentCambridge,


MA

ID:
23A-03

Full-Time/RegularNearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.

At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.

Our tenacious, passionate employees challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.

This is life-changing work, and we are all in, are you?Akebia is seeking a VP, Clinical Development & Medical Affairs responsible for Clinical Development, Clinical Pharmacology, Clinical Operations, and Medical Affairs including the Field Medical organization.

The VP, Clinical Development and Medical Affairs can further strengthen the management team, serve as a highly visible, credible medical and scientific leader in the renal community, and bring strong leadership to the development organization.

Reporting to the Head of Research and Development, this individual will ensure the execution of clinical programs, including leading NDA filings, and execute on the strategic approach to maximize the value of vadadustat and future product candidates.

S/He will serve as an R&D leadership team member and partner to the senior management team in developing and implementing Akebias overall corporate strategy.

This VP will be scientific in his/her approach to development, patient centric, and possess a sense of urgency in executing Phase 1-4 clinical trials.

This individual will possess the skill to communicate effectively with a number of constituents, including members of the executive team, patients, patient advocacy groups, key medical experts (KMEs), investors, the Board of Directors, corporate partners, and regulatory agencies.

This will be a high profile and high impact position, responsible for executing, and delivering on critical clinical milestones including launching vadadustat and future product candidates.

The person hired for this position will, therefore, be a crucial leader for Akebia, and have significant influence shaping the future of the Company.

Key responsibilities will include:

Work closely with the SVP, R&D & CMO and other members of the leadership team to make strategic decisions and provide leadership in defining Akebias product pipeline, formulate and implement clinical and regulatory strategy, and build a leading kidney-focused biopharmaceutical company.

Draft and/or review and approve documents including protocols, investigator brochures, study reports, regulatory submissions, and publications.
Partner in developing a communication strategy which presents the value of Akebias products to prospective prescribers, payers, and investors.
Build and foster relationships with patients, KMEs and patient advocacy organizations.
Design clinical trials to optimize collection of therapeutic efficacy and safety endpoints and accelerate the progression of pipeline compounds.
Ensure that processes related to patient safety in the conduct of clinical trials are adhered to.
Communicate effectively with regulators, respond to regulatory queries on products submitted for approval, and guide presentations to Advisory Committees.
Develop and articulate Akebias mission at scientific meetings, in publications, with investors, Board members and other company forums.
Build and manage ad hoc Clinical Advisory Boards.
Liaise appropriately with external partners such as MTPC, Japan Tobacco, Vifor Pharma, and dialysis organizations.
Serve as a key advisor on potential licensing opportunities.
Identify, attract, develop, and retain qualified employees.
Partner in identifying and building new research and development programs to expand the Companys product pipeline.


Basic Qualifications:
MD degree is required. Nephrology training and/or exposure to renal diseases is highly desirable.

We will evaluate candidates with backgrounds in Cardiology, Endocrinology, or Internal Medicine10 years of experience in clinical development with 5 of those years in a leadership position and experience with investigational and commercial productsStrong understanding of late-stage product development, including clinical trial management, pre-launch planning, post-launch marketing, post-approval studies, regulatory affairs, and Good Clinical Practice (GCP) guidelines.

Preferred Qualifications:

Bring global experience (at the minimum in the US and EU) across all phases of development; have designed and led large, global clinical trials and helped to shepherd a product through regulatory approval.

Direct experience in medical affairs would be ideal but is not a requirement.

The candidate must have excellent oral and written communication skills as well as the ability to build cross-functional relationships and work collaboratively with other groups, both internally and externally.

Most importantly, this individual will be passionate, collaborative, creative, willing to take prudent risks, and focused on delivery of a large portfolio of diverse milestones.

Skilled in building, training, and motivating a clinical development and medical affairs team, ideally for an emerging biopharmaceutical company.
Strategic but still hands-on; proven ability to succeed in an entrepreneurial company.

Self-starter who will be an assertive and active participant with ability to work in a fast paced, dynamic, and collaborative environment.

Demonstrated commitment to achieving corporate objectives while maintaining high ethical, regulatory and scientific standards.
Accountability and commitment to delivery of results.
Able to multi-task across a broad range of activities while maintaining a strong sense of priorities.
Driven to progress programs and timelines rapidly.
Willingness to try new approaches.
Able to accept and respond to setbacks or failures.
Able to leverage outside resources and collaborate effectively.
Are you an Akebian?An Akebian is curious, empathetic, and values making connections to people and ideas.

Akebians arent afraid of diving in and owning a process or a problem, because we all want to deliver a great solution.

Akebians believe that we are better together because we are all working toward a common purpose to better the life of each person impacted by kidney disease.

Want to learn more about what it means to be an Akebian? Visit our website:

COVID 19 Vaccination:

All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.

Requests for accommodation will be considered on a case-by-case basis, and Akebia will consider, among other things whether a proposed accommodation would create an undue hardship.

Please note that it is unlikely that accommodations can be granted for customer-facing positions.
Akebia is an equal opportunity employer and welcomes all job applicants.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.