Senior Director, Medical Writing - CytomX Therapeutics
South San Francisco, CA
About the Job
Headquarters Location: South San Francisco, CA
Candidate Location: Hybrid, Onsite or Remote
Travel Required: 5%
Reports To: Vice President, Clinical Development
Department: Medical Writing
Position Type: Full-time, Exempt
About CytomX Therapeutics:
CytomX Therapeutics, Inc. is committed to changing the treatment of cancer with our novel Probody® therapeutic platform. Our commitment to transforming lives with safer, more effective therapies is driven by our curiosity and passion for innovation and our belief that by acting with integrity in an honest, respectful, ethical manner, we have the power to change lives. Our workplace embodies collaboration, open communication, celebrating our successes, and holding each other to the highest possible standards. CytomX has a broad pipeline, which comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engaging bispecific antibodies (“TCBs”), and immune modulators such as cytokines. Learn more at www.cytomX.com.
Who You Are and What You’ll Do:
You are passionate about life sciences and making a difference to cancer patients, their families, and healthcare providers. You will be responsible for conducting and supervising Medical Writing for the Clinical Development organization at CytomX, including all regulatory documents, publications and presentations of clinical data. The Senior Director, Medical Writing would be responsible for all regulatory documents (e.g. protocols, IBs, DSURs, briefing packages, global regulatory applications), as well as publications (e.g. manuscripts, abstracts, presentations). The successful candidate will write or oversee authoring and review of these documents, set and manage the budget for the Medical Writing department, ensure the documents are completed on time, on budget and with the highest possible quality. Department processes, SOPs and templates will also be under the purview of this role. As a member of the Clinical Development organization, this Senior Director is responsible for establishing and maintaining a work environment focused on quality and that fosters learning, respect, open communication, integrity, collaboration, integration, and teamwork.
The Senior Director, Medical Writing, will work directly with cross-functional stakeholders within CytomX (e.g., for the preparation of regulatory documents), as well as supervising any external Medical Writing Agencies as applicable. In addition, aligned with overall company growth, the Senior Director would have the opportunity to build the Medical Writing organization within CytomX and be responsible for establishing processes and workflows aligned with organizational growth.
Job Responsibilities:
- Supervise the preparation of all key documents related to the conduct and reporting of clinical studies at CytomX. These include, but are not limited to, regulatory submissions (e.g., protocols, informed consent forms, Investigator Brochure’s, Briefing Documents), manuscripts and other types of publications and presentations as required.
- Work with key cross-functional stakeholders to manage the content of all documents including, but not limited to: Clinical Development, Drug Safety, Pharmacovigilance, Regulatory, Clinical Operations, Data Management, Biometrics, Clinical Pharmacology, CMC/Manufacturing, Legal, Investor Relations, and Corporate Strategy.
- Establish and oversee clinical document review processes from initiation through authoring, review, and finalization.
- Collaborate with cross-functional representatives to develop and optimize systems and processes related to establishing and maintaining current document templates, maintaining document audit trails, and document storage.
- Partner with the VP of Investor Relations and Corporate Communications to ensure consistent communication for all written documents.
- Supervise the strategy and execution of the publication plan, a task that would include interaction with external consultants and/or external authors, as needed.
- Keeping current of standards/guidelines related to medical writing, e.g., TransCelerate protocol templates.
- Manage internal medical writing staff and/or external medical writing consultants.
- Business travel as required.
- Other duties as assigned.
Minimum Qualifications:
- Medical writer with 10+ years in the biopharma industry and 5+ years in medical writing, either with a focus in regulatory, publications or both
- Proven experience supervising medical writers, as direct manager, and/or as overseer of multiple consultants, contractors, or Agencies
- Proven experience as a leader in medical writing – able to develop and manage budgets and SOPs
- Proven experience and ability to prioritize and multi-task on multiple concurrent projects
Preferred Qualifications:
- Previous experience in oncology medical writing is preferred
- Experience in formatting presentations for medical presentations (e.g., poster presentations) a plus
- Advanced Science degree (MS, MD, PhD or PharmD) is a plus
How You Will Work:
- Demonstrates collaboration and teamwork. Works well with others and understands that collaboration leads to better results.
- Possesses strong communication skills. Communicates clearly, concisely, and professionally. Listens actively to build understanding.
- Exhibits strong interpersonal skills and self-awareness. Builds and cultivates strong and enduring relationships with others. Acts with humility and understands own strengths and weaknesses.
- Shows continuous improvement and a commitment to self-management and development. Operates with a continuous improvement mindset and continuously seeks to expand own knowledge and capabilities.
- Demonstrates a patient focus. Puts the patient first in actions and decisions taken.
- Contributes to strategy and innovation. Contributes to or leads elevating and actionable strategies. Ideates and creates unique opportunities to advance the organization.
- Demonstrates leadership and a commitment to organizational values. Takes ownership and has a strong sense of personal accountability. Consistently achieves or exceeds goals and expectations. Puts significant emphasis on living / upholding company values.
- Demonstrates ability and commitment to building effective teams. Attracts, develops, and retains diverse top talent. Aligns, mobilizes, and engages others to achieve and sustain peak performance.
- Has a track record of driving vision and purpose in teams.
Compensation, Benefits, and So Much More
- The expected salary range for this role based on the primary location for this position in California is $240,000 - $275,000 per year. Offer amounts are determined by factors such as experience, qualifications, geographic location, and other job-related factors permitted by law.
- A great environment where we work collaboratively, leverage each other’s strengths, and work toward a shared vision with our common goals of doing the best thing for patients.
- A robust and enduring approach to your development and career growth fueled by a strong learning curriculum and career guidance that helps you understand how you can grow your career at CytomX.
- A robust and highly competitive total rewards program that helps you achieve your compensation goals while supporting a great work / life balance.
Conditions of Employment
- Background investigations are required for all positions at CytomX, consistent with applicable law.
CytomX’s Commitment to Diversity, Equity, Inclusion, and Belonging (DEIB)
CytomX believes that DEIB helps drive our success, and we encourage candidates from all identities, backgrounds, and abilities to apply. We are an equal opportunity employer committed to building an inclusive, innovative work environment with employees who reflect our values and ultimately, serve our patients. Therefore, in all aspects of the employment process, we provide employment opportunities to all qualified applicants without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity or expression, pregnancy, medical condition related to pregnancy, creed, ancestry, national origin, marital status, genetic information, or military status, or any other protected status in accordance with applicable law.
Further, we are committed to the full inclusion of all qualified individuals. As part of this commitment, we (and the agencies we work with) will assist individuals who have a disability with any reasonable accommodation requests related to employment, including completing the application process, interviewing, completing any pre-employment testing, participating in the employee selection process, and/or to perform essential job functions where the requested accommodation does not impose an undue hardship. If you have a disability and require reasonable accommodation, or need other assistance in applying for or interviewing for this position, please direct your inquiries to Human Resources, at hr@cytomx.com
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact CytomX Therapeutics through this page. We require that all Recruitment Vendors (e.g., search firms, recruitment agencies and staffing companies) have a fully executed, formal written agreement on file with CytomX prior to submitting candidates. Any resumes submitted through the website or directly by Recruitment Vendors will be considered unsolicited. Unsolicited vendor submissions do not constitute any actual or implied contract with CytomX, and CytomX will not be responsible for any purported fees. For more information, please contact our HR team at hr@cytomx.com
Please review our Applicant Personal Information Processing Notice to understand what types of personal information we collect from job applicants and why we process such information.
Source : CytomX Therapeutics