Director – Regulatory Clinical Strategy Liaison @ Eikon Therapeutics

Director – Regulatory Clinical Strategy Liaison

Posted on 9/24/2023

INACTIVE

Locations

New York, NY, USA

Experience Level

Entry

Junior

Mid

Senior

Expert

Desired Skills

Communications

CategoriesNew

Business & Strategy

Legal & Compliance

Requirements

BA level required, Advanced degree preferred in life sciences, pharmacy, or a related field
Minimum of 10 years of experience in regulatory affairs within the biopharmaceutical industry, with a focus on clinical development
Proven track record of successful regulatory strategy development and execution for clinical development programs
Strong knowledge of global regulatory requirements and guidelines, including FDA and EMA regulations
Experience interacting with regulatory authorities, including participating in meetings and negotiations
Demonstrated ability to collaborate effectively with cross-functional teams and external stakeholders
Excellent communication and presentation skills, with the ability to convey complex regulatory information clearly and concisely
Strong leadership and mentorship abilities, with a passion for developing talent
Ability to adapt to a fast-paced and dynamic work environment, managing multiple projects and priorities simultaneously
High attention to detail, with a commitment to delivering high-quality work

Responsibilities

Regulatory Strategy Development: Lead the development and implementation of regulatory strategies for clinical development programs, in alignment with business objectives and regulatory requirements
Clinical Trial Planning: Collaborate with cross-functional teams, including Clinical Development, Medical Affairs, and Clinical Operations, to provide regulatory input and guidance on study design, protocol development, and clinical trial planning
Regulatory Submissions: Prepare and oversee the preparation of regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), amendments, and other relevant documents for global regulatory authorities
Health Authority Interactions: Serve as the primary point of contact for regulatory authorities during the clinical development process, including preparation and participation in regulatory agency meetings and interactions
Compliance and Risk Management: Ensure compliance with applicable regulations, guidelines, and standards throughout the clinical development process. Identify potential risks and develop mitigation strategies
Regulatory Intelligence: Stay abreast of evolving regulatory requirements, guidelines, and industry trends, and proactively communicate relevant updates to internal stakeholders to inform decision-making
Cross-Functional Collaboration: Collaborate closely with internal teams, including Clinical Development, Medical Affairs, Pharmacovigilance, and Quality Assurance, to align regulatory strategies and provide regulatory input at key milestones
External Stakeholder Engagement: Build and maintain positive relationships with key opinion leaders, regulatory authorities, and external partners to facilitate the development and approval of investigational products
Team Leadership and Mentoring: Provide guidance and mentorship to junior team members, fostering their professional growth and development within the regulatory affairs function

Description

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Position

The Director, Regulatory Clinical Strategy Liaison will play a critical role in supporting our clinical development programs by providing strategic regulatory guidance and expertise. This position will collaborate with cross-functional teams and external stakeholders to develop and execute regulatory strategies that ensure compliance with global regulations and expedite the approval process for our investigational products.

About You

You’re a Regulatory Clinical Strategy expert and leader who loves to solve difficult problems and are not discouraged by challenges. You’re a hands-on project manager who thrives in a fast-paced, dynamic environment. You’re well-organized, detail oriented, and take pride in your ability to rapidly analyze situations and judicious decisions. You’re collaborative by nature with uncompromising integrity. You’re conscientious and pay almost obsessive attention to detail, documentation and organization are second nature. You thrive on the excitement of being a foundational member of a rapidly growing high visibility team.

What you’ll do

Regulatory Strategy Development: Lead the development and implementation of regulatory strategies for clinical development programs, in alignment with business objectives and regulatory requirements.
Clinical Trial Planning: Collaborate with cross-functional teams, including Clinical Development, Medical Affairs, and Clinical Operations, to provide regulatory input and guidance on study design, protocol development, and clinical trial planning.
Regulatory Submissions: Prepare and oversee the preparation of regulatory submissions, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), amendments, and other relevant documents for global regulatory authorities.
Health Authority Interactions: Serve as the primary point of contact for regulatory authorities during the clinical development process, including preparation and participation in regulatory agency meetings and interactions.
Compliance and Risk Management: Ensure compliance with applicable regulations, guidelines, and standards throughout the clinical development process. Identify potential risks and develop mitigation strategies.
Regulatory Intelligence: Stay abreast of evolving regulatory requirements, guidelines, and industry trends, and proactively communicate relevant updates to internal stakeholders to inform decision-making.
Cross-Functional Collaboration: Collaborate closely with internal teams, including Clinical Development, Medical Affairs, Pharmacovigilance, and Quality Assurance, to align regulatory strategies and provide regulatory input at key milestones.
External Stakeholder Engagement: Build and maintain positive relationships with key opinion leaders, regulatory authorities, and external partners to facilitate the development and approval of investigational products.
Team Leadership and Mentoring: Provide guidance and mentorship to junior team members, fostering their professional growth and development within the regulatory affairs function.

Qualifications

BA level required, Advanced degree preferred in life sciences, pharmacy, or a related field.
Minimum of 10 years of experience in regulatory affairs within the biopharmaceutical industry, with a focus on clinical development.
Proven track record of successful regulatory strategy development and execution for clinical development programs.
Strong knowledge of global regulatory requirements and guidelines, including FDA and EMA regulations.
Experience interacting with regulatory authorities, including participating in meetings and negotiations.
Demonstrated ability to collaborate effectively with cross-functional teams and external stakeholders.
Excellent communication and presentation skills, with the ability to convey complex regulatory information clearly and concisely.
Strong leadership and mentorship abilities, with a passion for developing talent.
Ability to adapt to a fast-paced and dynamic work environment, managing multiple projects and priorities simultaneously.
High attention to detail, with a commitment to delivering high-quality work.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

401k plan with company matching
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
Mental health and wellness benefits
Weeklong summer and winter holiday shutdowns
Generous paid time off and holiday policies
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
Enhanced parental leave benefit
Daily subsidized lunch program when on-site

The expected salary range for this role is $191,000 to $220,000 depending on skills, competency and the market demand for your expertise.

Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

In accordance with the Company’s duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA’s emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California’s Fair Employment and Housing Act, you will need to contact the Company’s Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.

We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.