RETAINED SEARCH: Sr. Medical Director (lead Ph 2 to NDA) – Late-Stage Biotech (Critical Care Immunotherapy): RTP, NC

Cornerstone Search Group
Published
October 17, 2017
Category
Job Code
lrBH2619csg
Contact Email
lcrodriguez@cornerstonesg.com

Description

RETAINED SEARCH: Sr. Medical Director (lead Ph 2 to NDA) - Late-Stage Biotech (Critical Care Immunotherapy): RTP, NC

Summary: Cornerstone Search Group’s Specialized MD Practice has been retained by a late-stage, pre-IPO biotech company whose lead clinical candidate’s lead indication is in Phase III. It is a first-in-class, “Fast Tracked” immunotherapy treatment for acute life-threatening conditions such as AKI and serious infections that can lead to loss of limb or life. They need a talented MD with industry or PI experience to join their growing team to lead an upcoming Phase II program through to NDA. This highly visible role reports to a personable and respected CMO and will be working right alongside the executive leadership team. Our client is backed by highly respected biotech venture capital companies.

Company: This well-funded, innovative, pre-IPO biotech has a well-proven leadership team with demonstrated success leading pre- & post-IPO companies.

Title: Senior Medical Director (Clinical R&D)

Location: Research Triangle Park, NC metro area

Attractive Features about this Position and Company:

  • Gain Valuable Late Phase (II & III) & Regulatory Submissions (NDA & MAA) Experience
  • Clinical Development Leadership Opportunity: You will have the opportunity to manage and lead an indication from Phase II inception through to NDA/MAA.
  • The CMO is a willing mentor who has a lot of experience and very good communication skills.
  • Visibility: You will work alongside the entire executive leadership team, getting to know and interacting meaningfully with the C-level executives.
  • Innovative Company: This company is focused on innovative immunotherapy approaches to acute care indications such as AKI and life-threatening infections. Their lead compound in development is a first-in-class, internally developed candidate that has gained “Fast Track Status”.
  • Small Company Culture: You will be working in a collegial, fast-paced environment where you’ll have the opportunity to learn all facets of clinical drug development rather than the more limited role an MD plays in a CRO or in a large pharma.

Responsibilities:

  • Provide Medical/Clinical support for multiple indications of a late-stage asset, including leading an indication into Phase II through to NDA/MAA.
  • Provide Medical/Clinical support for the preparation and review of regulatory documents (briefing documents for regulatory meetings, IND submissions/updates, NDA/MAA submissions).
  • Provide medical leadership/support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents.
  • Review and sign off on adverse events reports and provide reports to the FDA, European Regulatory Authorities, and other regulatory agencies.
  • Provide support in preparation of Safety Update Reports (PSURs/DSURs).
  • Review and sign off on Data Management listings of safety data (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication), establish the presence or absence of clinically meaningful trends and, if noted, follow up as appropriate with the internal study team, investigator, and Regulatory Authorities.
  • Medical leadership in responding to inquiry/questions, both internally and externally.
  • Review all documents assigned for scientifically/medically relevant issues including drug safety.
  • Attend and present material (such as therapeutic area training) as requested, at internal and external meetings (e.g. investigator meetings).
  • Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
  • Maintain up-to-date knowledge of therapeutic indications expertise by attending professional society meetings.

Requirements:

  • An MD, MBBS, MBBCh, BMBS, MBChB, or DO degree is required.
  • Ideal medical training backgrounds include Immunology, Surgical, Hospitalist, Emergency Medicine, Critical Care, Infectious Disease, Pediatrics and Internal Medicine.
  • Seeking relevant Pharma / Biotech / CRO / academic clinical development experience. May consider a talented person with lighter experience for a Director title rather than Sr. Director.
  • Ability to interact and collaborate cross-functionally
  • Passion and desire to bring an innovative, life-saving clinical candidate to market.

CONTACT:

Corey S. Ackerman, JD | Senior Partner

cackerman@cornerstonesg.com

https://www.linkedin.com/in/coreyackerman/

973.656.0220 x716

Lavinia C. Rodriguez

lcrodriguez@cornerstonesg.com

https://www.linkedin.com/in/laviniacrodriguez

973.656.0220 x740

CORNERSTONE SEARCH GROUP - Life Sciences Executive Search

Six Campus Drive | Suite 301 | Parsippany, NJ 07054 USA

www.cornerstonesg.com

USA: 973.656.0220

CH: 41 61 508 7010

Recently Completed MD Search Assignments:

  • EVP, CMO – Clinical-Stage Oncology Biopharma – Boston Area
  • VP, Head of Clinical Development – Clinical-Stage Oncology Biopharma – Boston Area
  • EVP, Head of Oncology Global Medical Affairs – mid-size Global pharma – New Jersey
  • Executive Director, Clinical Development, Oncology – small Global pharma – New Jersey

Cornerstone’s Privacy Policy: Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted to us as confidential information. This information will not be shared with any parties outside of Cornerstone Search Group without your prior permission.

Keywords: surgery surgical immuno immunology anti-virus virology anti-infective, antiinfective, anti-biotic, antibiotic oncology cancer respiratory pediatrician clinical research physician clinical R&D dermatology executive director SD ED principal investigator

Apply
Drop files here browse files ...
PDF and .doc resume uploads are preferred. docx files are not supported.