Head of Clinical Pharmacology | Growing, well-funded NJ-based Biopharma | Report to CMO: RETAINED SEARCH
Summary: Cornerstone Search Group has been retained by a highly attractive Oncology/Immunology-focused global Biopharma for a newly-created Head of Clinical Pharmacology position reporting to the CMO. This is a uniquely attractive “best-of-both-worlds” opportunity because you will enjoy the benefit of working in a smaller, entrepreneurial environment while still having the security afforded by having a large, diverse, and internally-created pipeline and being a very well-funded company. Furthermore, our client has multiple strategic relationships/collaborations with top Pharma companies.
As compared to many Clinical Pharmacology leadership roles in mid-size and larger companies, this opportunity immediately cuts through the "red tape" and gives you the ability to be directly responsible for their Clinical Pharmacology success and interact at the highest levels of the organization in the US and globally. You will build the Clinical Pharmacology group from scratch and they are looking for a qualified candidate that can develop strategy, work cross-functionally, build a team and also remain a hands-on influence to the department. Please note that while Oncology experience is a plus, it is not required, so it can be a unique opportunity to gain Oncology experience.
Location: North/Central New Jersey. Commutable from various locations in NJ, NYC and PA. Partial work-from-home may be considered for those who live far away or can’t permanently relocate to the area.
Relocation Benefits: Our client will provide relocation for those outside of the area.
Attractive features about this position and company:
- High Visibility: You will report directly to a very accomplished CMO and have regular interaction with the highest levels of the organization.
- Full Ownership: Ability to set strategy, build and maintain infrastructure, and lead all Clinical Pharmacology aspects for the company.
- Diverse and Attractive Pipeline: 7+ compounds in clinical stage (I-III) development for various liquid and solid tumor indications being studied as mono or combination therapies.
- Company Stability & Growth: Our client is positioned to operate in a lean and creative manner, while also maintaining a very stable and strong growth position.
- Proven Executive Leadership: The executives here are highly engaged, emotionally even-keeled, entrepreneurial, and committed to creating an environment where top-notch people can get the job done right.
Responsibilities: Challenges, Expectations and Deliverables for this position:
- Clinical Pharmacology ownership across the entire portfolio.
- Build and organize the Clinical Pharmacology Team.
- Ensure appropriate Clinical Pharmacology representation on drug/dosage form development and clinical teams and provision of PK/PD expertise and leadership.
- Plan and direct Clinical Pharmacology components of clinical programs (including clinical development plan/life cycle plan) and studies (including synopsis and protocol preparation; clinical phase oversight, reporting).
- Leadership of multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and ensure overall scientific accountability for the designated studies.
- Responsible (with members of Clinicians and Statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses in first in human studies and dosage regimens in patients.
- Summarize and interpret results of pharmacokinetic, pharmacodynamic analyses with respect to their impact on development and clinical use of drugs.
- During the pre-clinical stages of drug development, work with Research/Biological Sciences to ensure that sufficient preclinical PK/PD knowledge exists to support progression into first in human studies.
- Accountable for ensuring that there are valid methods for measuring drug and metabolite concentrations (or any biomarkers) in human studies.
- Responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off. Assist with internal and external dissemination of results to Development Team, Investigators, etc.
- Provide recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing, etc.) to the Clinical and Development teams and in regulatory documentation such as labeling.
- Stay abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology and therapeutics knowledge in terms of both medical background and clinical trial design.
- Participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management.
- Act as technical lead for specific development projects, Phase I/III and Clinical Pharmacology centric studies.
- Manage and initiate external collaborations with leaders in clinical pharmacology and Key Opinion Leaders.
Experiences, Skills, Accomplishments and Qualities Desired:
- MD, PhD or PharmD in pharmacology or related field.
- Hematology/Oncology experience is preferred, but not required.
- 10+ years of Clinical Pharmacology expertise in pharmaceutical/biotech industry.
- Direct experience with clinical pharmacology summary documents required for Regulatory submissions.
- Experience in clinical development and new drug registration.
- Good ability to interpret complex clinical data and experimental results.
- Ability to manage people and budget.
Thomas Fascia | Partner
P 973-656-0220 x717
CORNERSTONE SEARCH GROUP - Life Sciences Executive Search
Six Campus Drive | Parsippany, NJ 07054 USA
Recent Retained Searches:
- SVP, Head of Global Medical Affairs – mid-size Oncology company
- CMO – Mid-Size Global Pharma
- VP, Head of Translational Medicine – Boston Oncology Biotech
- EVP, Head of Oncology Clinical Development – mid-size Oncology company
- Group VP, Global Commercial Head – API Business Unit
- VP, Head of Biologics Business Development – Mid-size Global Biotech
- VP, Head of R&D Operations
- CSO, Mid-size Global Biotech
- VP, Head of Health Economics & Outcomes Research – mid-size global pharma