Executive Director, Medical Writing
Apply NowCompany: Xenon
Location: Boston, MA 02115
Description:
Who We Are:
Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.
What We Do:
We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 "X-NOVA" clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.
About the Role:
We are seeking an Executive Director, Medical Writing to join our team. This is a department head position. The Executive Director manages and oversees the medical writing function at Xenon and is responsible for the efficient preparation of high quality, strategically aligned medical writing deliverables that support clinical development and regulatory requirements across multiple clinical programs. As an integral member of the clinical development team, the Executive Director actively contributes to strategic program planning and has complete oversight of medical writing deliverables.
This position reports to the Senior Vice President, Regulatory Affairs and will be based out of Boston, MA, USA in our Needham office. This role is a hybrid position, requiring a minimum of 2 days per week in the office.
RESPONSIBILITIES:
Oversees a team of Regulatory and Medical Writers which includes being accountable for performance, team engagement, coaching and mentorship.
Develop and implement medical writing strategies and operational plans across clinical development programs.
Provide leadership and strategic direction to the medical writing function, ensuring alignment with regulatory and business goals.
Oversee document strategy for regulatory submissions, including clinical protocols, study reports, investigator brochures, and Common Technical Document components.
Build effective partnerships with cross-functional teams (e.g., regulatory affairs, clinical development, biometrics).
Provide strategic input during the review cycles of documents and guide teams through resolution processes.
Initiate and drive strategic medical writing initiatives with high technical acumen to ensure execution on company priorities.
Author or oversee the creation of high-quality clinical and regulatory documents such as protocols, clinical study reports, briefing books, INDs/CTAs, NDAs, and Investigator Brochures.
Ensure accuracy, clarity, and consistency in messaging across all documents supporting regulatory submissions.
Apply expert medical writing proficiency to lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages.
Conduct quality control reviews of documents prepared by other writers or stakeholders.
Ensure compliance with global regulatory requirements (e.g., ICH guidelines) and industry standards in all written materials.
Support clinical trial transparency efforts by managing disclosures on platforms like ClinicalTrials.gov and EudraCT.
Evaluate and enhance medical writing processes, policies, standard operating procedures, training and work guidance to improve efficiency, quality, and compliance with Good Clinical Practice (GCP) and Good Documentation Practices (GDP).
Develop templates and training programs for medical writing processes to ensure consistency across projects.
Work collaboratively with subject matter experts to integrate scientific content into documents.
Represent the medical writing function in cross-functional team meetings to ensure timely delivery of documents.
Oversee resource allocation for internal teams and external vendors based on project needs.
Stay updated on emerging regulatory guidelines and industry best practices related to medical writing.
Build collaborations with external organizations to align with professional standards and advancements in the field.
Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
Plan and manage budget proposals and approved budgets in accordance with the Company's strategic and operating plans and Finance policies.
Recruit, lead, direct, develop, coach and evaluate direct reports in accordance with the Company's Human Resource policies and practices.
Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
Some international travel may be required.
Other duties as assigned.
QUALIFICATIONS:
A Bachelor's, Master's, or PhD in a scientific, medical, or clinical discipline.
15+ years of industry regulatory writing and clinical medical writing experience.
12+ years of management experience, or a combination of degrees and experience, in the pharmaceutical/biopharmaceutical industry or at a clinical contract research organization (CRO), preferably in neurosciences.
Strong understanding of global regulatory requirements (FDA, EMA, Health Canada, and ICH guidelines) for clinical trial documentation and transparency.
Extensive experience writing regulatory submission documents across all phases of drug development (e.g., clinical protocols, Investigator's Brochures, clinical study reports, briefing books, INDs/CTAs, NDAs/MAAs).
Exceptional written and verbal communication skills, with a strong understanding of clinical data and the ability to communicate complex scientific concepts clearly and effectively.
Proven organizational skills and the ability to manage multiple competing priorities.
Exceptional interpersonal and team skills to work collaboratively as part of a multidisciplinary team.
Expert in Microsoft Word, Excel, PowerPoint, and related word processing and electronic publishing tools.
Expert knowledge of document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
Experience with EndNote and StartingPoint templates desired.
The base salary range for this role is $244,290 to $309,000 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.
Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
As part of our hiring process, Xenon conducts background checks for finalist candidates. The types of checks conducted will vary depending on the relevance to the position.
US positions only: Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.
To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.
Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.
What We Do:
We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents the most advanced potassium channel modulator in clinical development for multiple indications. Building upon the positive results and compelling data from our Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our Phase 3 epilepsy program includes multiple clinical trials evaluating azetukalner in patients with focal onset seizures and primary generalized tonic-clonic seizures. In 2024, we are planning to initiate a Phase 3 azetukalner program in major depressive disorder, based on topline data from our Phase 2 "X-NOVA" clinical trial. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates. Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.
About the Role:
We are seeking an Executive Director, Medical Writing to join our team. This is a department head position. The Executive Director manages and oversees the medical writing function at Xenon and is responsible for the efficient preparation of high quality, strategically aligned medical writing deliverables that support clinical development and regulatory requirements across multiple clinical programs. As an integral member of the clinical development team, the Executive Director actively contributes to strategic program planning and has complete oversight of medical writing deliverables.
This position reports to the Senior Vice President, Regulatory Affairs and will be based out of Boston, MA, USA in our Needham office. This role is a hybrid position, requiring a minimum of 2 days per week in the office.
RESPONSIBILITIES:
Oversees a team of Regulatory and Medical Writers which includes being accountable for performance, team engagement, coaching and mentorship.
Develop and implement medical writing strategies and operational plans across clinical development programs.
Provide leadership and strategic direction to the medical writing function, ensuring alignment with regulatory and business goals.
Oversee document strategy for regulatory submissions, including clinical protocols, study reports, investigator brochures, and Common Technical Document components.
Build effective partnerships with cross-functional teams (e.g., regulatory affairs, clinical development, biometrics).
Provide strategic input during the review cycles of documents and guide teams through resolution processes.
Initiate and drive strategic medical writing initiatives with high technical acumen to ensure execution on company priorities.
Author or oversee the creation of high-quality clinical and regulatory documents such as protocols, clinical study reports, briefing books, INDs/CTAs, NDAs, and Investigator Brochures.
Ensure accuracy, clarity, and consistency in messaging across all documents supporting regulatory submissions.
Apply expert medical writing proficiency to lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages.
Conduct quality control reviews of documents prepared by other writers or stakeholders.
Ensure compliance with global regulatory requirements (e.g., ICH guidelines) and industry standards in all written materials.
Support clinical trial transparency efforts by managing disclosures on platforms like ClinicalTrials.gov and EudraCT.
Evaluate and enhance medical writing processes, policies, standard operating procedures, training and work guidance to improve efficiency, quality, and compliance with Good Clinical Practice (GCP) and Good Documentation Practices (GDP).
Develop templates and training programs for medical writing processes to ensure consistency across projects.
Work collaboratively with subject matter experts to integrate scientific content into documents.
Represent the medical writing function in cross-functional team meetings to ensure timely delivery of documents.
Oversee resource allocation for internal teams and external vendors based on project needs.
Stay updated on emerging regulatory guidelines and industry best practices related to medical writing.
Build collaborations with external organizations to align with professional standards and advancements in the field.
Develop and propose short- and long-term objectives for the function in accordance with overall Company strategies and plans.
Plan and manage budget proposals and approved budgets in accordance with the Company's strategic and operating plans and Finance policies.
Recruit, lead, direct, develop, coach and evaluate direct reports in accordance with the Company's Human Resource policies and practices.
Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
Some international travel may be required.
Other duties as assigned.
QUALIFICATIONS:
A Bachelor's, Master's, or PhD in a scientific, medical, or clinical discipline.
15+ years of industry regulatory writing and clinical medical writing experience.
12+ years of management experience, or a combination of degrees and experience, in the pharmaceutical/biopharmaceutical industry or at a clinical contract research organization (CRO), preferably in neurosciences.
Strong understanding of global regulatory requirements (FDA, EMA, Health Canada, and ICH guidelines) for clinical trial documentation and transparency.
Extensive experience writing regulatory submission documents across all phases of drug development (e.g., clinical protocols, Investigator's Brochures, clinical study reports, briefing books, INDs/CTAs, NDAs/MAAs).
Exceptional written and verbal communication skills, with a strong understanding of clinical data and the ability to communicate complex scientific concepts clearly and effectively.
Proven organizational skills and the ability to manage multiple competing priorities.
Exceptional interpersonal and team skills to work collaboratively as part of a multidisciplinary team.
Expert in Microsoft Word, Excel, PowerPoint, and related word processing and electronic publishing tools.
Expert knowledge of document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
Experience with EndNote and StartingPoint templates desired.
The base salary range for this role is $244,290 to $309,000 USD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.
Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
As part of our hiring process, Xenon conducts background checks for finalist candidates. The types of checks conducted will vary depending on the relevance to the position.
US positions only: Xenon Pharmaceuticals USA Inc. participates in the E-Verify program in all states in which we hire. Learn more about the E-Verify program here.
To apply for this position, click Apply Now to complete the application. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.