Senior Medical Director, Pharmacovigilance and Safety

Orukatx; Maryland; Remote; USD 265,000 - 295,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Senior Medical Director for Pharmacovigilance and Safety. This remote role focuses on overseeing drug safety activities, ensuring high-quality data generation, and collaborating with a dynamic team to enhance patient safety in clinical studies. Candidates with a medical degree and substantial experience in pharmacovigilance are encouraged to apply for this impactful leadership opportunity.

Benefits

Competitive salary and equity

Professional growth and development opportunities

Vibrant small-company culture

Qualifications

• 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 environment.

Responsibilities

• Oversee and manage medical safety activities and processes.
• Provide medical safety input into clinical trial design and conduct.
• Interpret and present safety data analyses to stakeholders.

Skills

Leadership

Communication

Analytical Skills

Education

Medical degree (MD/DO or equivalent)

Tools

Argus

MedDRA

Veeva Vault

Job description

Senior Medical Director, Pharmacovigilance and Safety

Remote

About Us:

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’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. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. We have raised nearly $500M since inception in February 2024 from top-tier investors and our first program is expected to be in the clinic in the first quarter of 2025. For more information, visit www.orukatx.com

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 if located near Waltham, MA or Menlo Park, CA office and will be required to be in-office in 3 days/week.

Role Overview:

The Senior Medical Director of Pharmacovigilance and Safety plays a key role in the oversight and strategic direction of drug safety and pharmacovigilance activities in our clinical studies. This role will help ensure high-quality data generation to support the safety and efficacy of our pipeline products. The role will manage medical safety activities and processes, oversee our pharmacovigilance vendor(s), and ensure continuous assessment of safety profiles and benefit-risk of investigational compounds. The Senior Medical Director collaborates closely with internal and external stakeholders to ensure compliance with regulations and guidelines, contribute to safety regulatory documents, and protect participant safety.

Key Responsibilities:

Safety Leadership and Risk Management:

• Responsible for safety surveillance and risk management activities including but not limited to: medical review of Individual Case Safety Reports (ICSRs), routine review of safety data, and ongoing review of assessments for safety signals or in response to Regulatory Authority requests.
• Provides medical safety input into the design and conduct of clinical trials
• Plans and interprets safety data analyses, prepare and present safety data summaries to internal and external stakeholders
• Acquire and contribute knowledge of relevant drug class and/or competitor safety issues
• Lead the development of safety surveillance strategy, identify potential clinical safety issues, and recommend appropriate risk mitigation measures
• Establish and maintain collaborative working relationships with all key stakeholders (e.g., clinical study teams, safety CROs, business partners) which require expert contribution to the development of the product safety strategy
• Accountable for risk management activities including preparation and maintenance of relevant sections of clinical trial protocols, IBs (including the reference safety information section), ICFs, DSURs, RMPs
• Proficient with safety surveillance systems and tools (e.g., Argus, MedDRA, Veeva Vault)

Medical Expertise:

• Develop response strategies in collaboration with internal and external collaborators, providing medical-scientific input to regulatory documents for safety-related requests from health authorities and other external parties
• Contribute to regulatory authority submissions during the lifecycle of drug development
• Accountable for the safety components of study reports (i.e., CSRs), aggregate reports (DSUR, PSUR) and other regulatory documents.
• Provide insights and leadership and development of IDMC and Adjudication Committee Charters
• Consistently comply with all governing laws, regulations, standard operating procedures (SOPs) and other guidelines.
• Apply previous experience in safety data analysis, including analyzing trends and patterns in large datasets

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.
• 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 in Waltham, MA or Menlo Park, CA or remotely is $265,000 to $295,000. 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. Oruka 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

$265,000 - $295,000 USD

What We Offer:

• A chance to be part of a vibrant small-company culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• Opportunities for professional growth and development.

Apply for this job

*

indicates a required field

First Name *

Last Name *

Email *

Phone *

Resume/CV *

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Education

School * Select...

Degree * Select...

Select...

Select...

Start date year

End date month Select...

End date year

Are you currently fully eligible to work in the United States of America? * Select...

Do you now or will you, at a future date, require visa sponsorship to work in the United States? * Select...

Please provide your home address. *

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Oruka Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305

Page 1 of 1

OMB Control Number 1250-0005

Expires 04/30/2026

Voluntary Self-Identification of Disability

Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

• Alcohol or other substance use disorder (not currently using drugs illegally)
• Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
• Blind or low vision
• Cancer (past or present)
• Cardiovascular or heart disease
• Celiac disease
• Cerebral palsy
• Deaf or serious difficulty hearing
• Diabetes
• Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
• Epilepsy or other seizure disorder
• Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
• Intellectual or developmental disability
• Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
• Missing limbs or partially missing limbs
• Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
• Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
• Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
• Partial or complete paralysis (any cause)
• Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
• Short stature (dwarfism)
• Traumatic brain injury

Disability Status Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.