VP/Head, Early Clinical Development and Translational Medicine (MD): Oncology Biotech | Boston area: RETAINED SEARCH
A uniquely attractive Oncology biotech company is seeking a physician to serve as the Head of their Early Clinical Development and Translational Medicine group, reporting directly to the CMO/Head of R&D. This biotech is helmed by proven, impressive industry veterans and has nearly 10 assets in the IND through Phase III stages, with plans to launch their first asset in 2020 and their second soon afterwards.
Our client is a Company that offers the “best of both worlds,” i.e. working for a very well financed Company that maintains an agile “start-up” culture: makes quick decisions and fosters a collegial environment.
Location: Boston/Cambridge area
As VP/Head of Early Clinical Development and Translational Medicine you will be responsible for building, leading and managing the function and having strategic and hands-on responsibility for the entire early pipeline of assets.
This Company’s assets feature different mechanism of actions (I/O, TKI, metabolic, etc.), they target both solid tumor and hematological cancers, and several have been granted the FDA’s Orphan Drug designation. Unlike many biotechs, they have a wide breadth of assets and they are quite sustainably financed (which helps with sign-on bonuses and relocation packages).
Position Scope / Responsibilities:
- The VP/Head will develop and execute translational medicine and early development strategy to effectively bridge preclinical and early clinical phases to improve overall success/speed of this company’s wide portfolio of assets.
- In collaboration with internal and external R&D partners (other pharma/biotechs as well as academic research centers), lead the Translational Medicine effort of compounds from pre-IND studies to the proof-of-concept (PoC) phase.
- You and your team of MDs and PhDs will be responsible for the integrated development plan (IDP) through PoC in partnership with other functional areas. This includes the assessment of medical need, proposal of clinical development pathways, and review of preclinical data for clinical implications, acquisition of clinical samples and other relevant activities.
- In close collaboration with research scientists (internal and external), you and your team will identify, develop, and implement strategy for preclinical support of program-related objectives.
- Develops the First in Human (FIH) and PoC strategy such as the selection of endpoints, design, safety evaluations, and initial dose selections.
- Lead global project teams through PoC phase to drive implementation of the PoC strategy by providing medical and scientific leadership and expertise to all line functions on the project team.
- Accountable for compound related biomarker strategies; works closely with biomarker experts in implementation. Guide teams to align preclinical and clinical biomarker strategies.
- Contribute to the evaluation of clinical centers and foster communication with crucial collaborating investigators in collaboration with Clinical Operations.
- Responsible for the implementation of additional supporting studies during the research and PoC phases, which may include methodology studies to identify and validate novel endpoints for early decision making in PoC studies and identify endpoints by which patient populations can be stratified to optimize chances of detecting signs of activity of candidate molecules in early clinical studies.
- Participates in the analysis of study results and presents conclusions to relevant decision boards.
- Ensure the overall quality of appropriate aspects of Clinical Plan, Study Synopses, Study Protocols, and Clinical Trial Reports (CTRs) and Summaries (e.g. slide format and executive summaries).
- Participate in team presentations to health authorities including IND, and Clinical Trial Authorization (CTA) IB, annual safety report, etc.
- Acts as the primary Company representative to various Health Authorities and invite appropriate experts (internal and external) together with focus on early development.
- Facilitate the establishment and maintenance of effective collaborations with academic institutions and patient foundations.
- Develop and manage yearly budget for the department and ensure appropriate alignment to agreed portfolio.
Compensation: Our client has the financial ability to offer a very competitive compensation package, including sign-on bonuses to address annual bonus forfeitures and unvested stock forfeitures.
Relocation: Our client has a very attractive relocation program, which is far more comprehensive than a typical biotech company.
Travel: Anticipated travel is ~10%, mainly to conferences and to internal and external R&D partners.
Desired Skills / Experiences:
- MD or MD/PhD with at least 10 years of relevant experience.
- Prior experience with a pharma or biotech is preferred.
- A broad knowledge of oncology/hematology.
- Demonstrated track record in the planning, control and monitoring of early clinical drug development projects.
- Demonstrated track record in supporting global translational medicine projects.
- Prior direct report experience is a plus.
- Prior experience managing multiple assets simultaneously is a plus.
- Prior global experience is a plus.
- The collective medical, scientific, and business acumen that leads to the ability to influence senior leaders and stakeholders and lead complex partnership and alliance activities.
- Demonstrated track record of adopting novel translational medicine and early clinical development approaches to the advancement of assets is desired.
- Proven record of scientific achievement as evidenced by presentations and publications in peer reviewed journals.
- Strong knowledge of Translational Medicine, Pharmacogenetics and Clinical Pharmacology within the oncology field.
Steve Raz | Managing Partner
P: 973.656.0220 x712
CORNERSTONE SEARCH GROUP - Pharma & Biotech Executive Search
Six Campus Drive | Suite 301 | Parsippany, New Jersey 07054 USA
About Cornerstone Search Group: Recognized by Forbes as one of the Top Executive Search Firms in the USA (2017 & 2018), we are an industry-leading Pharma & Biotech Executive Search Firm that works with small biotech startups all the way through to large branded & generic pharmas. We are particularly known for our long history of success in helping small, lesser-known US and Internationally-based pharmas/biotechs compete for top talent at the Director, VP, and CxO (CEO, CMO, CSO, CCO] levels.
Keywords: Advisory, Advocacy, Affairs, Analysis, Analyze, Antibody, Asset, Biomarker, BLA, Board, Cell, Certified, Clinical, Clinician, Committee, Concept, Data, Development, Diagnostics, Director, Doctor, Early, Efficacy, Executive, FDA,Gene, Global, Head, IND, Indication, Investigator, Interpret, Key, KOL, Late, Launch, Lead, Leadership, mAB, Manager, Management, MD, M.D., Medical, Molecule, NDA, Novel, Patient, Phase, Physician, PI, Pivotal, PoC,Present, Product, Program, Proof, R&D, Registrational, Regulatory, Research, Review, Scientific, Scientist, Sr, Senior, Safety, Strategic, Study, Supervise, Target, Therapeutic Area, Therapy, Translational, Treatment, Trial