Olema Oncology
Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs
Olema Oncology, San Francisco, California, United States, 94199
Overview 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.
Increase your chances of reaching the interview stage by reading the complete job description and applying promptly. Our scientific breakthroughs are accelerated by supporting, motivating, and challenging one another. At Olema, we put people first, and our work strives to make a profound impact for our patients, for your career, and for what is beyond. You can view our latest corporate deck and other presentations here. About the Role
— Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs Responsibilities
Lead the development of the New Drug Application (NDA). Lead the development and execution of innovative regulatory strategies supporting Olema products. Represent Regulatory Affairs on cross-functional teams as the subject matter expert and provide regulatory guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee. Provide strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD, etc.). This role is based out of Boston, MA or San Francisco, CA and will require domestic and international travel up to 20%. What You Will Do
Lead the development and submission of the NDA for the company\'s lead program Develop innovative global regulatory strategies for the Olema portfolio in clinical development and lifecycle management as needed. Represent Regulatory Affairs on cross-functional teams as the SME and provide regulatory guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee. Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics, and devices. Provide strategic and tactical guidance and lead regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD, etc.). Represent Olema with Global Health Authorities and lead Agency interactions to achieve company objectives. Identify gaps and develop risk mitigation strategies for regulatory submissions. Ensure Olema\'s regulatory activities are robust and compliant with Health Authority regulatory requirements. Coordinate and maintain all HA reporting schedules in collaboration with cross-functional teams. Be flexible to adapt and accommodate additional duties as assigned. And will also include Lead the development of Regulatory Affairs department policies, SOPs, and work instructions. Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva). Keep leadership informed of the regulatory landscape, including HA initiatives and impact on Olema\'s programs. Lead the global regulatory team(s) and ensure execution of regulatory strategies to achieve company objectives. Mentor and develop other regulatory colleagues in the department. Support SVP Regulatory Affairs, as required. Ideal Candidate Profile
Innovative Experienced Regulatory Strategy Leader A love of challenging, important work.
We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees play a unique and crucial role in our success. We are looking for someone with the right combination of knowledge, experience, and attributes for this role. Knowledge
Bachelor’s degree in a scientific discipline Advanced degree in scientific discipline (Masters, PharmD or PhD preferred) Experience
At least 12 years’ experience in Regulatory Affairs in Pharma/Biotech Minimum of 3 years direct leadership experience Experience with development and execution of regulatory strategies in Oncology is strongly preferred Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices Experience with major regulatory submissions (NDA/NDS/MAA) is a must Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on regulatory strategy Ability to work in a fast-paced, hands-on environment Excellent oral, written, and presentation skills; experience presenting to leadership teams Demonstrated proficiency in cross-functional collaboration on global teams Excellent planning and organizational skills with ability to manage multiple projects on tight timelines Experience in all phases of development and post-marketing activities is highly preferred Demonstrated ability to analyze and interpret efficacy and safety data Strong understanding of regulatory operational activities Attributes
Self-starter Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities Team player On-site presence at the headquarter is required (minimum 2 days a week) Compensation The base pay range for this position is expected to be
$275,000-$290,000
annually. The base pay offered may vary depending on location, market, job-related knowledge, skills, capabilities, and experience. The total compensation package includes equity, bonus, and benefits. Important Information Olema provides equal opportunity to all employees and applicants for employment. We celebrate diversity and are committed to creating an inclusive environment for all employees. We offer a competitive compensation and benefits package and provide an open, flexible, and friendly work environment to empower employees and support long-term career development. A Summary of Benefits is available for all applicants. Please note:
Olema does not accept agency resumes and is not responsible for fees related to unsolicited resumes. This job posting is not an invitation for fraudulent activity. Olema does not conduct interviews via text message or messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, and will not make job offers without an in-person interview. Fraud Alert:
We are aware of employment scams where individuals pose as Olema representatives. Our official email addresses end in @olema.com. Our official site is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Use these links for official information.
#J-18808-Ljbffr
Increase your chances of reaching the interview stage by reading the complete job description and applying promptly. Our scientific breakthroughs are accelerated by supporting, motivating, and challenging one another. At Olema, we put people first, and our work strives to make a profound impact for our patients, for your career, and for what is beyond. You can view our latest corporate deck and other presentations here. About the Role
— Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs Responsibilities
Lead the development of the New Drug Application (NDA). Lead the development and execution of innovative regulatory strategies supporting Olema products. Represent Regulatory Affairs on cross-functional teams as the subject matter expert and provide regulatory guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee. Provide strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD, etc.). This role is based out of Boston, MA or San Francisco, CA and will require domestic and international travel up to 20%. What You Will Do
Lead the development and submission of the NDA for the company\'s lead program Develop innovative global regulatory strategies for the Olema portfolio in clinical development and lifecycle management as needed. Represent Regulatory Affairs on cross-functional teams as the SME and provide regulatory guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee. Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics, and devices. Provide strategic and tactical guidance and lead regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DMF, IMPD, etc.). Represent Olema with Global Health Authorities and lead Agency interactions to achieve company objectives. Identify gaps and develop risk mitigation strategies for regulatory submissions. Ensure Olema\'s regulatory activities are robust and compliant with Health Authority regulatory requirements. Coordinate and maintain all HA reporting schedules in collaboration with cross-functional teams. Be flexible to adapt and accommodate additional duties as assigned. And will also include Lead the development of Regulatory Affairs department policies, SOPs, and work instructions. Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva). Keep leadership informed of the regulatory landscape, including HA initiatives and impact on Olema\'s programs. Lead the global regulatory team(s) and ensure execution of regulatory strategies to achieve company objectives. Mentor and develop other regulatory colleagues in the department. Support SVP Regulatory Affairs, as required. Ideal Candidate Profile
Innovative Experienced Regulatory Strategy Leader A love of challenging, important work.
We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees play a unique and crucial role in our success. We are looking for someone with the right combination of knowledge, experience, and attributes for this role. Knowledge
Bachelor’s degree in a scientific discipline Advanced degree in scientific discipline (Masters, PharmD or PhD preferred) Experience
At least 12 years’ experience in Regulatory Affairs in Pharma/Biotech Minimum of 3 years direct leadership experience Experience with development and execution of regulatory strategies in Oncology is strongly preferred Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices Experience with major regulatory submissions (NDA/NDS/MAA) is a must Experience in strategic problem-solving and negotiation with Health Authorities and leading internal teams on regulatory strategy Ability to work in a fast-paced, hands-on environment Excellent oral, written, and presentation skills; experience presenting to leadership teams Demonstrated proficiency in cross-functional collaboration on global teams Excellent planning and organizational skills with ability to manage multiple projects on tight timelines Experience in all phases of development and post-marketing activities is highly preferred Demonstrated ability to analyze and interpret efficacy and safety data Strong understanding of regulatory operational activities Attributes
Self-starter Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities Team player On-site presence at the headquarter is required (minimum 2 days a week) Compensation The base pay range for this position is expected to be
$275,000-$290,000
annually. The base pay offered may vary depending on location, market, job-related knowledge, skills, capabilities, and experience. The total compensation package includes equity, bonus, and benefits. Important Information Olema provides equal opportunity to all employees and applicants for employment. We celebrate diversity and are committed to creating an inclusive environment for all employees. We offer a competitive compensation and benefits package and provide an open, flexible, and friendly work environment to empower employees and support long-term career development. A Summary of Benefits is available for all applicants. Please note:
Olema does not accept agency resumes and is not responsible for fees related to unsolicited resumes. This job posting is not an invitation for fraudulent activity. Olema does not conduct interviews via text message or messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, and will not make job offers without an in-person interview. Fraud Alert:
We are aware of employment scams where individuals pose as Olema representatives. Our official email addresses end in @olema.com. Our official site is olema.com; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Use these links for official information.
#J-18808-Ljbffr