Senior Medical Director, Product Safety, Pharmacovigilance, and Risk Management - Maryland, United States - Poseida Therapeutics, Inc.

Description

Description

**Please note that while this position has been designated as remote based the position will be required to observe Pacific hours.

Your Impact

As Senior Medical Director, Product Safety and Risk Management you will have the opportunity to collaborate with an experienced and tight knit Clinical Development, Clinical Operations and Regulatory team. In this role you will have the unique opportunity to lead the safety and pharmacovigilance function in support of Poseida's oncology cell therapy programs. We understand the meaning of team and are looking for an individual that is passionate about being a part of something bigger and a driving force in changing the lives of cancer patients.

Position Summary

The Senior Medical Director, Product Safety, Pharmacovigilance & Risk Management will be responsible for the safety, pharmacovigilance (PV) and medical monitoring activities of multiple clinical trials and potentially multiple clinical programs, and will also participate in the development of, clinical development plans, clinical trial protocols, data analyses, clinical study reports, investigator brochures and other clinical and regulatory documents. The position will be involved with pre-marketing clinical trials. This individual will have a broad understanding of internal medicine, oncology and clinical pharmacology. The position will entail opportunities to be the external "face" of the company in interactions with investigators, regulatory authorities, contract research organizations (CRO) and development partners. This individual will require strong leadership capabilities and a vision to build a world-class safety reporting, and pharmacovigilance function.

Responsibilities

These may include but are not limited to:

• Accountable to build a world-class safety function
• Leads and oversees ongoing medical and safety monitoring of Poseida's partner and investigational cell therapy products, including overseeing trending assessment and safety signal detection
• Leads all Poseida led or sponsored clinical trials safety reporting including assuring all trials have a plan in place including, as needed, a formal pharmacovigilance plan
• Accountable to assure all safety reporting requirements are met. In support of this will work closely with regulatory team and CRO
• Generates, authors, and/or reviews product safety reports as required by the worldwide regulatory agencies by developing safety data retrieval strategy and assessing the significance of relevant safety information
• Leads investigational drug and post-marketing pharmacovigilance, working in conjunction with the CROs, including the generation of narrative and completion of medwatch forms and the authorship of Periodic Safety Update Reports
• Assures timely completion of all risk assessments as part of the Risk Management Plan for all products and make recommendations to the core safety and product labeling as part of the fulfillment of the Pharmacovigilance function, The risk assessment will follow the guidance documents from applicable regulators.
• Interfacing with external key opinion leaders, advocacy groups and advisory boards, representing the safety function
• Oversee the development, approval and issuance of drug core information and informed consent documents and recommend changes from scientific inputs when necessary.
• Oversee development of product risk/benefit or health hazard analysis and assessment to aim appropriate regulatory actions for drug safety and/or quality issues.

Requirements

Requirements, Knowledge, Skills and Abilities

• MD/DO degree required, preferably with post-graduate, broad-based specialty training (e.g., internal medicine, oncology, specialty)
• Minimum of 5 years of clinical practice experience strongly preferred
• Minimum of 5 plus years of applicable industry experience in a biotechnology or pharmaceutical company in a job position performing many or most of the responsibilities in this job description, preferably in a fast-paced, dynamic environment
• Extensive external networks within the oncology therapeutic area. Previous experience within cell therapy desired.
• Excellent working knowledge of FDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical drug development
• Intimate knowledge of and high level expertise in the day-to-day medical monitoring of clinical trials (e.g., responding to questions about patient eligibility and protocol waivers; review of safety parameters; receiving and processing SAEs, including the composition of SAE narratives; and IND expedited safety reports)
• Knowledge and expertise in pharmacovigilance, including the receipt and processing of ADRs, narrative composition/editing, classification of safety events, completion of MedWatch forms, and generation of Periodic Safety Update Reports
• Demonstrated experience and expertise in the primary authorship of multiple clinical trial protocols, design of case report forms and the design of clinical data listing and tables for clinical trials
• Preferable to have demonstrated experience and expertise in the primary authorship of clinical study reports, including oversight of the generation of tables, figures and listings from the study database
• Ability to juggle multiple projects at the same time, with good time management skills and the ability to prioritize appropriately.
• Must be able to work with a high level of autonomy, but also able to identify issues that require supervisory input
• Excellent oral, written, and interpersonal communication skills
• Excellent analytical skills
• Demonstrated track record of being results driven and highly productive
• Travel anticipated up to 10% of time.

Senior Medical Director, Product Safety, Pharmacovigilance and Risk Management Pay Rate: $312,000 to $342,000

The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc.

Who We Are and What We Do

Based in San Diego, Poseida Therapeutics is a clinical-stage biopharmaceutical company utilizing our unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single treatment cures for patients in need. Our portfolio of product candidates is specifically designed to overcome the limitations of current generation cell and gene therapeutics.

At Poseida we put people first. Our team is passionate about improving patients' lives through innovation. See what our team has to say about our culture:

"My favorite part about Poseida is all the people that I get to work with. Everyone is so passionate about what we're doing here and there's so much camaraderie. It feels like one big enthusiastic family."

"My favorite part about working at Poseida is the amazing culture and working environment. Everybody is friendly, professional, collaborative, and has a remarkable can-do and positive attitude."

As we advance our compelling pipeline, there are endless opportunities for impact and growth. We encourage you to apply today

Recruitment Fraud Alert

Alert: Beware of Employment Scams

Poseida Therapeutics, Inc. has received reports of employment-related scams. These scams have appeared in forms of false job advertisements and/or unsolicited contacts via communication/chat platforms, phone, email or text from individual(s) claiming to be or represent Poseida's Human Resources team. Be advised that Poseida Therapeutics does not extend unsolicited employment offers. Furthermore, Poseida Therapeutics does not request payment information or charge prospective employees with any fees during the recruitment process.

If you would like to pursue employment opportunities with Poseida Therapeutics, Inc., please visit our official careers website or official Poseida Therapeutics LinkedIn page . Job postings that do not link directly to our careers website or official Poseida LinkedIn page are not legitimate and might be fraudulent. You may report fraudulent job advertisements or contacts via our Contact Us page at and select the subject "Careers." If you have been defrauded or suspect identity theft as a result of an employment scam, please contact your local law enforcement agency for guidance.