After years of residency, a hematology-oncology fellowship, and several more years as an attending physician with experience in clinical trials (in an academic medical center or hybrid private practice), you’ve decided to explore a career in drug development in biopharmaceuticals. As you stand on the cusp of this decision, you begin to realize how little you know about a career in industry. Where do you even begin to look? Should you consider applying to biotechnology or large pharmaceutical companies? How do roles vary in each of these settings? What is the day-to-day experience like?

My hope is that the following paragraphs shed some light on answers to these questions and outline what a career in biopharmaceuticals can look like. Two caveats to mention up front: first, the content of these lines will be primarily slanted toward my experience in clinical development rather than a pathway in medical affairs, and second, some of my points regarding differences between biotechnology and large pharmaceutical companies may be oversimplifications.

The first step as you begin your search for an initial clinical development position is to talk with individuals who were at a similar career level before transitioning to industry. Although it is valuable to discuss your impending transition with colleagues or mentors who may be in more senior leadership positions within biopharmaceuticals, their experience may not be reflective of the experience awaiting you. Hearing from individuals who were peers before their transition can offer you a realistic perspective as to what roles were offered to them, such as medical director, senior medical director, and therapeutic area clinical lead; what such a role looked like; and what level of compensation to anticipate. Beyond receiving information on what to anticipate, perhaps as important is for these individuals to offer you introductions to recruiters who have helped them in the past, either in-house from large pharmaceutical companies or from independent life science recruitment groups.

Having a recruiter to serve as a guide is not just a luxury but essential to successfully navigating the interview process. Seasoned recruiters can guide you on how to prepare for interviews and provide feedback as you climb the interview rungs about impressions of your prospective employer.

You’ve now been connected to a recruiter who has offered current openings across several exciting oncology-focused companies, which span the spectrum of biotechnology to large pharmaceutical companies. Which type of company should you apply to? Perhaps a primer is warranted.

Biotechnology companies are mostly private, and large pharmaceutical companies are usually public. This means that there is less of a built-in structure for conducting business in biotechnology compared with large pharmaceutical companies. There are not mandated metronomic investor calls or internal decision-making meetings that dictate the pace of each drug project. In biotechnology, internal milestones can be more individually curated depending on the needs of a particular drug program at a certain time. Additionally, the differences in employee numbers between large pharmaceutical and biotechnology companies also carry implications on the scope of your role. Given the vast cadre of experienced individuals in each branch of large pharmaceutical companies, your role tends to be more anchored to the clinical work related to a single trial or several trials with your molecule of focus. In biotechnology, given the smaller company size, your role tends to be more interdisciplinary. Even in clinical development, beyond direct trial work, one day you may be working with your legal team to refine a request for a proposal template and the next you could be working with your manufacturing team to review shipping details for a drug for a trial.

Furthermore, there is less of a distinction between early and late clinical development in biotechnology. For example, an oncology-focused biotechnology company with a diverse portfolio typically possesses 2 to 3 clinical assets and a pipeline that may include several more preclinical compounds identified through a drug discovery platform. The clinical assets are typically in early-phase trials given the cost and scale of conducting phase 3 trials. Regardless of what phase of study a drug is in, you are responsible for the entirety of its development in biotechnology. In contrast, there is a significant distinction between early- and late-phase clinical development in large pharmaceutical companies, with separate teams focusing on individual phases for even the same molecule. If you were involved with an asset that demonstrated exceptional promise in proof-of-concept phase 2 trial findings, it would then be moved out of your hands to colleagues in late clinical development. That is not to say you cannot transition between early- and late-phase clinical development in large pharmaceutical companies, but you can only work in 1 space at a given time.

Due to this more pronounced distinction between phases of clinical development in large pharmaceutical companies, your day-to-day role also tends to be more predictable. In early clinical development, you usually work with the translational science team to get preclinical assets ready for an investigational new drug application and with the pharmacokinetics and biomarker teams to contextualize the results of a phase 1 trial. In late clinical development, you may work more regularly with the regulatory team to plan for an upcoming FDA meeting about your planned registrational trial, with the biostatistics team to refine statistically powered primary and key secondary end points for the trial, and with the medical affairs team to discuss recruitment strategies.

In biotechnology, your day-to-day role may be much more unpredictable. You might be working with a contract research organization to ensure the development of your phase 1 protocol is proceeding as planned, then pivot to a business development meeting about entering a collaboration with another company based on synergy between your drug and theirs, before finishing your day reviewing in vivo data with your scientific team about a preclinical asset. The next day, your interactions could be completely different.

In short, I hope to have highlighted the diverse opportunities a clinical development career in biopharmaceuticals may afford. Given the technological update the field of oncology is actively undergoing with the introduction of new therapeutic modalities and refinement of existing ones, it is undoubtedly an exciting time to be in the field of drug development. Know that you are not alone as you approach the transition; there are others who have made similar leaps and are open to sharing their experiences and learnings. Welcome.

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Transitioning from a clinical role to a career in biopharmaceutical drug development involves understanding the differences between biotechnology and large pharmaceutical companies. Biotechnology firms, often private, offer interdisciplinary roles with less structured business operations, while large pharmaceutical companies, typically public, provide more defined roles with clear distinctions between early and late clinical development phases. Engaging with peers who have made similar transitions and leveraging recruiters can facilitate this career shift. The dynamic nature of oncology drug development presents exciting opportunities for those entering the field.

Satya (Nanu) Das, MD, MSCI, pens this piece on what a career in drug development in the biopharmaceutical field may look like. 

A Career in Clinical Development in Industry: Choose Your Own Adventure

Satya Das, MD, MSCI, assistant professor of medicine, Department of Medicine, Division of Hematology/Oncology, Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, discusses the results of a clinical score analysis in patients with neuroendocrine tumors (NETs).

During the 2021 ASCO Gastrointestinal Cancers Symposium, the results of a study evaluating the utility of a clinical score for patients with progressive, well-differentiated NETs who were under consideration for peptide receptor radionuclide therapy (PRRT) with Lutathera (lutetium Lu 177 dotatate) were presented in a virtual presentation.

The results showed that the estimated hazard ratio (HR) for progression-free survival (PFS) was 3.26 for each 2-point increase in clinical score among the 115 patients who received 3 to 4 doses of PRRT, which was considered the full dose. In the 31 patients not treated with PRRT, for each 2-point increase in clinical score, the HR for PFS was 1.37. This suggests that clinical score is predictive for PFS benefit in patients who receive PRRT, but not in those who receive another treatment, Das concludes. 

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Satya Das, MD, MSCI, discusses the results of a clinical score analysis in patients with neuroendocrine tumors.  



Satya Das, MD, MSCI

Articles

A Career in Clinical Development in Industry: Choose Your Own Adventure

Dr. Das on the Results of a Clinical Score Analysis in Patients With NETs