Orca Bio

Associate Director, Medical Information

Sacramento, California, United States

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Pharmaceuticals, HealthcareIndustries

Requirements

Candidates must possess an advanced clinical/scientific degree, preferably a Pharm.D. or Ph.D., with at least 8 years of experience in medical information or a related pharmaceutical industry role. Hematology/Oncology therapeutic area experience is required, with cell therapy experience being preferred. Experience with promotional and medical review committees, managing external call centers, and a strong understanding of pharmaceutical legal and regulatory guidelines are also necessary. Proficiency in various technology platforms such as Medical Information database systems, SharePoint, Veeva, and PowerPoint is essential.

Responsibilities

The Associate Director, Medical Information will establish and manage a global medical information service, including its budget, structure, business processes, and systems for disseminating scientific information. This role involves collaborating with Safety and QA on adverse event and product quality complaint processes, identifying and overseeing Medical Information call centers, and contributing to congress planning and on-site representation. Responsibilities also include developing and maintaining medical information materials like standard response documents and FAQs, reviewing and approving promotional and non-promotional materials as part of review committees, creating dashboards to track and communicate Medical Information activities, and collaborating with HEOR on dossier development. Additionally, the Associate Director will create and train colleagues on a process for submitting unsolicited requests for medical information.

Skills

Medical Information
Medical Affairs
Biotechnology
Cell Therapy
Budget Management
Business Process
Scientific Information Dissemination
Adverse Event Reporting
Product Quality Complaints
Call Center Management
Congress Planning
On-site Representation

Orca Bio

Develops and commercializes cell therapies

About Orca Bio

Orca Bio operates in the biotechnology sector, specifically focusing on cell therapies that utilize the body's own cells to treat diseases. The company works to enhance these therapies, aiming to make them safer and more effective for patients. Orca Bio's products are primarily used by healthcare providers who administer these therapies to patients as part of their treatment plans. Unlike many competitors, Orca Bio emphasizes a strong team culture and values communication with stakeholders, keeping them informed about the company's progress and developments. The goal of Orca Bio is to improve patient outcomes through advanced cell therapies, addressing conditions that currently have limited treatment options.

Menlo Park, CaliforniaHeadquarters
2016Year Founded
$186.8MTotal Funding
SERIES_DCompany Stage
Biotechnology, HealthcareIndustries
51-200Employees

Benefits

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Unlimited Paid Time Off
401(k) Retirement Plan
Parental Leave

Risks

Emerging competition from BlueRock Therapeutics in stem cell therapies.
Aspen Neuroscience's advancements in personalized stem cell therapies pose a threat.
Competitors' focus on iPSC-derived therapies may overshadow Orca Bio's offerings.

Differentiation

Orca Bio focuses on high-precision cell therapies for cancer and autoimmune diseases.
Their lead product, Orca-T, shows promising relapse-free survival rates in clinical trials.
Orca Bio's therapies aim to replace diseased blood and immune systems with healthy ones.

Upsides

Orca-T demonstrated 87% relapse-free survival in a Phase 1b/2 trial.
FDA's expedited approval pathways could accelerate Orca Bio's market entry.
Advancements in gene editing enhance the efficacy of Orca Bio's cell therapies.

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