Senior Director, Drug Safety & Pharmacovigilance - CytomX Therapeutics
South San Francisco, CA
About the Job
Headquarters Location: South San Francisco, CA
Candidate Location: Hybrid
Travel Required: 5%
Reports To: Vice President, Clinical Development
Department: Pharmacovigilance
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 seven therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engaging bispecific antibodies (“TCBs”), and immune modulators such as cytokines and checkpoint inhibitors (“CPIs”). 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. The Senior Director, Drug Safety & Pharmacovigilance will be responsible for building and leading the safety and pharmacovigilance efforts for the Clinical Development organization. The successful candidate can successfully identify and address abstract problems across clinical programs. As a member of the clinical leadership team, this Senior Director is responsible for establishing and maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork. This role allows the incumbent to build the in-house drug safety function in a fast-growing biotech and have the pharmacovigilance responsibility across the proprietary Probody® portfolio.
Job Responsibilities:
- Own the Clinical Safety strategy for all clinical-stage product candidates through all stages of development
- Lead the growing safety team and develop talent, serve as line manager to junior-level staff within the Drug Safety and Pharmacovigilance department
- Interact with and / or supervise Drug Safety / Pharmacovigilance CROs
- Direct expedited safety reporting in accordance with regulatory requirements, serve as final adjudicator of safety reporting to health authorities
- Efficiently review/assess adverse events and all other safety information to anticipate and manage the safety profile of compounds in clinical development, including identifying necessary updates to reference safety information and drive risk management initiatives according to global regulatory requirements
- Final author for all regulatory safety documents, e.g., Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), template informed consents, Investigator Brochures
- Final reviewer for safety deliverables prior to database locks (coding, SAE reconciliation)
- Provide required oversight to safety operations provided by external partners (CRO and consultants)
- Proactively evaluate the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to predict / establish the safety profile of compounds in clinical development, including employing expert groups and methodologies, Safety Science, Informatics expertise, modeling and simulation to manage the risk to patients, including close interactions with clinical pharmacology
- Translate safety findings from pre-clinical toxicology studies into recommendations for safety monitoring for first-in-human studies
- Collaborate with experts from academic institutions to further evaluate safety findings and develop risk mitigation strategies, thereby promoting the high-quality evaluation of safety data
- Provide strategic clinical safety input for clinical development planning activities
- Support and contribute to the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents as required
- Oversee implementation of safety signal detection and introduce new concepts of signal detection as the safety database grows, including platform specific signal detection
- Business travel as required
- Other duties as assigned
Minimum Qualifications:
- MD board certified internist or equivalent with 8+ years of safety/clinical development experience in the biopharma industry
- 5+ years of proven leadership/line management experience
- Proven experience with and knowledge of clinical research and global regulatory requirements with a focus on safety reporting (e.g., IND, BLA filings, etc.), practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities
- A solid grasp of safety and pharmacovigilance principles with respect to early clinical trials, data analysis and interpretation is required
- Experience with safety databases (i.e. Argus) and safety coding dictionaries (i.e. MedRA, WHODRUG)
- Experience in managing vendors, such as CROs
- Well versed in clinical aspects of FDA and global regulatory guidance and regulations
- Successful track record of establishing relationships with external constituents (i.e. clinical/research experts, government agencies and regulatory bodies), effectively collaborating on a multi-disciplinary team of peers and outside experts
Preferred Qualifications:
- Development experience in oncology drug development, immune oncology agents, a plus
- Excellent clinical and scientific presentation skills, negotiation and decision-making skills
- A commitment to developing drugs that will make a difference in the lives of patients
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 $305,000 - $362,000 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
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Source : CytomX Therapeutics