Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond. You can view our latest corporate deck and other presentations here.
About the Role >>> Senior Director, Regulatory Labeling, Advertisement and Promotions
As the Senior Director, Regulatory Labeling, Advertisement and Promotions reporting to the Senior Vice President, Regulatory Affairs you will lead the developmentof labeling for clinical supplies as well as development of commercial labeling materials for Olema products.The role will also oversee the development of regulatory complianceadvertisements and promotional materials for assigned Olema products. This role requires a solid understanding of regulatoryrequirements for labeling advertisement and promotional materials.
This role will work closely internally with Regulatory Affairs, Clinical Development, Commercial, Legal, Clinical Supply (CS), Quality Assurance (QA), and the CMC teams as well as external vendors to ensure appropriate quality control checks are proceduralized and implemented for all labeling and promotional activities.This role is based out of our Cambridge or San Francisco office and will require up to 20% travel.
Ideal Candidate Profile >>>
- Develop and maintain labeling documents including Company Core Data Sheets (CCDS), Structured Product Labeling (SPL), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SmPC), and their associated Patient Labeling Documents.
- Oversee the prioritization, development, revision and approval of clinical supply labeling (e.g., active, placebos and standard of care drugs) in various countries to support Olema’s clinical pipeline.
- Provide leadership and guidance to cross-functional labeling teams and align on the labeling content
- Oversee and manage the commercial label and promotional materials life cycles and associated systems.
- Develop and implement harmonized labeling processes for developing new product labels, promotional materials, and associated life-cycle activities.
- Lead the development of Standard Operating Procedures (SOPs) and process improvements for labeling and promotional materials generation and maintenance.
- Represent Olema with the FDA/OPDP as required and manage the regulatory interactions and oversee all the labeling and promotional material submissions to Health Authorities.
- Represent Regulatory Affairs Labeling, Advertisement and Promotions on project teams across products and ensure standard implementation of regulations across development products.
- Provide regulatory leadership on cross-functional promotional review Committee(s) to ensure development of regulatory compliant advertisement and promotional materials.
- Oversee labeling and promotional material activities managed by external vendors, ensuring coordination and timely delivery
- As a key leader in the Regulatory Affairs organization, you will shape the team’s structure and strategy to ensure long-term success by building and mentoring Regulatory labeling, advertisement and Promotions team within the department and mentor junior staff.You will build an organization with exceptional talent, setting performance standards, and cultivating an inclusive, high-energy environment that empowers individuals to do their best work and grow their careers.
A love of challenging, important work.
We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.Knowledge:
- Bachelor’s degree is required. A bachelor's degree in a scientific field or a master's degree isstrongly preferred.
- Understands Regulatory, Quality and Supply Chain aspects of clinical labeling and impact of non-compliance.
- Knowledge of applicable regulations and standards affecting labeling and packaging of investigational drugs globally.
- Strong knowledge and understanding of FDA promotional material regulations for oncology products.
- Expert knowledge of evidentiary standards supporting product claims.
- Strong knowledge of FDA and EMA product labeling requirements, regulations, and guidelines (USPI experience required, SmPC experience preferred).
- Extensive knowledge and experience with development of promotional materials in accordance with regulations.
Experience:
- 12+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 10+ years of Regulatory Affairs experience within clinical research or pharmaceutical. Proven 5-7 years of leadership role.
- Experience in regulatory affairs and quality assurance and deep knowledge of global regulatory labeling and promotional materials development and maintenance.
- Experience working with ICH Health Authorities. ,
- Experience with developing and managing labeling and promotional content for major submissions (e.g., NDA/BLA), through negotiations and approval preferredrequired.
- Demonstrated ability to work cross-functionally to develop project plans; proactively identify risks; develop risk mitigation strategies; communicate project team decisions and project status.
- Ability to interact successfully in a diverse global environment and with senior level management to effectively influence and manage change.
- Proven general understanding of clinical study designs and Global Manufacturing Practices (GMP) documentation.
- Demonstrated Oncology product label, advertisement/promotional materials expertise is required.
Attributes:
- Strong communication skills and the ability to effectively build productive internal and external working relationships.
- Strong oral and written communication and negotiation skills.
- Strong organizational, project management, and time management skills.
- Ability to independently execute day-to-day responsibilities.
- Ability to independently exercise judgement in developing methods, techniques, and evaluation criteria for obtaining results in a fast-paced environment consisting of internal and external team members.
- Excellent attention to detail, strong critical thinking, problem solving, and managing change.
The base pay range for this position is expected to be $260,000 - $290,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.#LI- MK1
Important Information
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We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes.
Thank you.
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Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.
