Senior Medical Director, Pharmacovigilance and Safety

About Us

The company (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. The company’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. The company is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon the company and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit [link for members]

As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.  Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.

Job Title:   Senior Medical Director, Pharmacovigilance and Safety

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.

Role Overview

The company is seeking an experienced, collaborative pharmacovigilance leader to provide medical and scientific safety oversight for the company’s investigational products. The Senior Medical Director, Pharmacovigilance and Safety will lead safety activities and processes, oversee the company’s pharmacovigilance vendors, and ensure continuous assessment of each product's safety profile and benefit-risk balance. This role will also serve as the medical safety expert on cross-functional development teams, working closely with internal and external stakeholders to ensure compliance with regulations and guidelines, contribute to safety regulatory documents, and protect participant safety.

The successful candidate will combine strong clinical judgment and pharmacovigilance expertise with a team-oriented approach suited to a growing biotechnology company. The role will also help develop the company’s pharmacovigilance infrastructure, processes, governance, and vendor partnerships as the portfolio advances through clinical development and toward registration.

Key Responsibilities

Product Safety Leadership and Risk Management

• Develop and lead product safety surveillance strategies, identify emerging clinical safety issues, and recommend appropriate risk-mitigation measures.

• Conduct or oversee routine and ad hoc reviews of safety data, monitor for safety signals, and maintain awareness of relevant drug-class and competitor safety issues.

• Lead ongoing aggregate safety review and chair internal safety governance committees.

• Plan and interpret safety data analyses; prepare and present safety data summaries to internal and external stakeholders.

• Build effective working relationships with clinical study teams, safety vendors, and business partners to align on product safety strategy.

Medical Safety Oversight

• Oversee expedited safety reporting, including medical review of Individual Case Safety Reports (ICSRs), suspected unexpected serious adverse reactions (SUSARs), and other reportable safety events.

• Ensure appropriate medical follow-up and consistent medical assessment of individual safety cases.

• Provide medical review of clinical trial safety data, including adverse events, laboratory results, vital signs, ECGs, exposure data, and relevant nonclinical or external information.

• Provide medical safety guidance to investigators, study teams, and internal stakeholders.

Clinical Development and Regulatory Support

• Lead safety-related aggregate reporting and the preparation and maintenance of relevant sections of Investigator's Brochures, including Reference Safety Information, Development Safety Update Reports, Risk Management Plans, and other regulatory documents.

• Provide safety input into clinical development plans, study protocols, informed consent forms, case report forms, statistical analysis plans, data-monitoring plans, and clinical study reports.

• Represent Pharmacovigilance in correspondence and meetings with the FDA and other global regulatory authorities.

• Maintain current knowledge of global pharmacovigilance regulations and guidance and ensure activities comply with applicable requirements, standard operating procedures, and other internal guidelines.

Pharmacovigilance Infrastructure and External Partnerships

• Help build and continuously improve the company’s pharmacovigilance system as the company and clinical portfolio grow.

• Oversee pharmacovigilance vendors supporting case processing, safety-database management, aggregate reporting, and literature surveillance.

• Set clear vendor expectations, monitor quality and performance, and ensure timely resolution of issues

• Provide safety leadership for independent data monitoring committees and adjudication committees, including development of charters, data-review plans, meeting materials, and recommendations.

• Support inspection readiness and represent Pharmacovigilance during regulatory inspections, audits, and due-diligence activities.

Required Qualifications

• Medical degree (MD/DO or equivalent) with completed residency.

• Minimum of 6 years of safety experience within the pharmaceutical industry.

• Strong expertise in global pharmacovigilance regulations and requirements.

• Demonstrated ability to work effectively in a dynamic, cross-functional, and fast-paced team environment.

• Proficient with safety surveillance systems and tools (e.g., Argus, MedDRA, Veeva Vault)

• Ability to work effectively in a dynamic, cross-functional, and fast-paced team environment.

• Excellent communication, leadership, and analytical skills.

Compensation

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.

• The anticipated salary range for candidates, who will work remotely or Waltham, MA   is $306,000 to $343,000. The final salary 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 within the industry, education, etc. The company is a multi-state employer and this salary range may not reflect positions that work in other states. If candidate is remote travel expectation will be up to 20% of the time.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Salary Range for the Role

$306,000 — $343,000 USD

What We Offer

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.

• Competitive salary and benefits package.

• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.

• Opportunities for professional growth and development.