Sr. Director, Global Regulatory Affairs, Oncology | Lead GRA Team & Strategies | Boston Area

SUMMARY:

You will lead Global Regulatory Affairs (GRA) strategies and RA Team in this highly visible Sr. Directorship position that will focus on a very important novel oncology cell therapy treatment.  You will make significant contributions to the important GRA discussions and decisions that will influence and impact the regulatory filings/submissions for this company’s leading cell therapy product. You will step-in and manage an existing team, and you will build/expand this team too.

This opportunity offers the best of both worlds, i.e., the best of what a well-established pharma and small biotech both offer.  As a well-established pharma, this company provides significant annual revenues & profits, financial strength, and stability, a very strong early & later-stage development pipeline in multiple therapeutic areas, attractive compensation, an extensive benefits package. And, as a well-established pharma that operates like a small biotech, it offers visibility, minimal layers of management/bureaucracy, high visibility, a real opportunity to significantly contribute to and influence important discussions and decisions around global regulatory strategies, a collegial work environment, a nimble/swift decision-making environment and more.     

LOCATION: Boston, MA Area | Relocation Assistance

ATTRACTIVE FEATURES INCLUDE (AMONG OTHERS):

• Leadership: you will lead and manage a GRA Team
• Build: you will add and expand your GRA team
• Manage: you will lead, mentor, and develop RA team members
• Visibility: you will report directly to Executive Leadership for the Oncology Therapeutic Area
• Impact: you will be in a Regulatory Affairs Leadership position that will significantly impact key strategic decisions
• Influence: you will make significant contributions to strategic discussions and decisions re: Regulatory Strategies
• Gain valuable experience: you will gain valuable Regulatory strategy & filing experience with a novel Cell Therapy
• Advancement: you will be in a great position for future promotional advancement
• Top 20 Biopharma: join an established and expanding global pharma/biotech industry leader
• Competitive compensation and benefits package: receive a strong compensation & benefits package
• Best of both worlds: enjoy the best of what an established large pharma company offers (i.e., significant annual revenues & profits, financial strength and stability, very strong early & later-stage development pipelines in multiple therapeutic areas, attractive compensation and extensive benefits package) while ALSO enjoy what a small biotech offers (i.e. minimal layers of management/bureaucracy, visibility, a voice that is heard, a chance to significantly influence discussions and decisions, a chance to make major contributions and a real impact and more)

QUALIFICATIONS/REQUIREMENTS:

• Education: BA/BS and Advanced degree is highly preferred but not required
• 10+ years of progressive Regulatory Affairs experience, including strategy and filing experience
• Oncology, Hematology and/or Immuno-oncology Therapeutic Area experience
• Strong communication skills; strong oral, writing and presentation skills
• Management experience: direct and/or project management/leadership experience

CONFIDENTIALITY:  All communications are treated as highly confidential information.

CONTACT:

Cliff Miras | Managing Partner

E: cmiras@cornerstonesg.com

P: 973.656.0220 x755

LinkedIn: linkedin.com/in/cliffmiras

CORNERSTONE SEARCH GROUP

Pharma/Biotech Executive Search Specialists | Forbes “Top 250 Search Firm” for 2018 & 2017

www.cornerstonesg.com

About Cornerstone Search Group

Cornerstone Search Group (Cornerstone) is well-established "boutique" Pharma/Biotech Specialty Executive Search Firm. Cornerstone has been recognized by Forbes as a “Top 250 USA Search Firm” in 2017 & 2018. Cornerstone helps both US-based and internationally-based Life Sciences companies—companies that range from lesser known preclinical and/or early-stage biotech companies up through several of the largest global pharma industry leaders---in their efforts to find, attract and hire talent for leadership positions (CxO/EVP/SVP/VP levels) and critical strategy, execution and operational level positions too (ED/SD/D levels) in multiple functional areas and therapeutic areas.

Keywords: cell therapy, oncology, hematology, immune-oncology, immune-oncology, immunology, cancer, FDA, NDA, strategies, labeling, filings, submissions, clinical, global, pathway, health authorities, leadership, management