Online professional certificate
Professional Certificate in Biotech Management
Coordinate biotech programmes with clear evidence, decision rights and practical handoffs across development, product, partners and strategy.
- Format
- Online, self-paced
- Study time
- Up to 1 month
- Curriculum
- 22 applied lessons
- Language
- English
Practical capability
Turn complex biotech work into decisions people can act on.
Build the coordination habits behind evidence-aware plans, specialist handoffs, product choices and sponsor decisions. Each capability is practised through a concrete workplace record.
Clarify the assignment, trace consequential claims to sources and separate observations from assumptions.
Map decision rights, dependencies, capacity and the next handoff before a date becomes a promise.
Route clinical, CMC, quality and regulatory questions to qualified owners and preserve pending status.
Connect user needs, evidence limits and roadmap tradeoffs to bounded product recommendations.
Prepare launch handoffs, screen partner evidence and frame transaction options within approval limits.
Test financing assumptions, request a sponsor decision and implement an approved change with a clear record.
Who this course is for
For professionals coordinating biotech decisions.
Built for people with basic biotech context who are beginning cross-functional management work or moving into an adjacent role.
The operating cycle
Move from an unclear request to a controlled decision.
The learning sequence follows the manager's operating rhythm: clarify, verify, coordinate, recommend and close the loop.
Curriculum
Four modules. Twenty-two applied lessons.
Frame and Coordinate Biotech Work
A biotech manager often receives a goal before the evidence, decision rights and dependencies are clear. This module shows you how to ask for the right information, distinguish facts from assumptions and agree who can decide what. You will build an initial plan, coordinate the people who contribute to it and run a useful check-in. By the end, you can show a sponsor what is known, what is pending and what must happen next.
01Clarify the Assignment
Practise how to define delegated scope, success, timing and decision rights and produce a usable scope-and-authority intake record.
Five practical steps
- Receive request
- Restate desired result
- Ask what is in scope
- Identify who approves
- Record deadline and first information request; confirm back to sponsor
Primary deliverable: Scope-and-authority intake record.
02Qualify Evidence and Assumptions
Practise how to separate validated evidence, source limits, open questions and specialist judgment and produce a usable evidence provenance and assumption register.
Five practical steps
- Identify decision-relevant claims
- Locate original sources
- Compare dates and versions
- Classify confirmed versus uncertain
- Ask the qualified owner to validate; update the register
Primary deliverable: Evidence provenance and assumption register.
03Map Owners and Handoffs
Practise how to assign functions, decision rights, receivers and acceptance conditions and produce a usable owner-interface and decision-rights map.
Five practical steps
- List workstreams
- Name accountable decision makers
- Define receiving teams
- Specify handoff conditions
- Test a disputed decision; confirm the map with owners
Primary deliverable: Owner-interface and decision-rights map.
04Build the Integrated Milestone Plan
Practise how to sequence outputs, dependencies, capacity and acceptance checks and produce a usable integrated milestone-and-dependency plan.
Five practical steps
- Start from accepted outputs
- Identify predecessors
- Ask owners for capacity
- Set conditional dates
- Add acceptance checks; expose the critical dependency; review with sponsor
Primary deliverable: Integrated milestone-and-dependency plan.
05Run the Cross-Functional Check-In
Practise how to facilitate disagreement and record decisions, actions and cadence and produce a usable meeting action and alignment record.
Five practical steps
- Set decision-focused agenda
- Circulate source facts
- Invite conflicting views
- Record what was decided
- Assign actions; send recap; verify acknowledgement
Primary deliverable: Meeting action and alignment record.
Deliver Across Clinical, CMC and Partner Workstreams
Delivery involves more than moving dates on a schedule. You need to recognize risks early, understand capacity limits and confirm that internal and external handoffs meet agreed acceptance conditions. You will practise the coordination around clinical, manufacturing, quality and regulatory work without taking specialist decisions for those functions. You will also prepare a regulatory evidence handoff and respond to a quality or manufacturing event through the right specialist route.
06Triage Issues, Risks and Escalation
Practise how to classify signals, assign owners and set response triggers and produce a usable issue-risk-escalation log.
Five practical steps
- Verify the event
- Classify issue versus risk
- Estimate effect
- Identify response owner
- Set trigger; communicate escalation; update status
Primary deliverable: Issue-risk-escalation log.
07Review Capacity and Budget Assumptions
Practise how to compare planned effort, owner capacity and cost ranges and produce a usable resource-capacity and budget-assumption view.
Five practical steps
- Gather capacity and cost inputs
- Distinguish estimate from commitment
- Model two feasible scenarios
- Check with finance and resource owners
- Present tradeoff
Primary deliverable: Resource-capacity and budget-assumption view.
08Coordinate External Deliverable Review and Handoff
Practise how to specify partner outputs, versions, checks and receiving owners and produce a usable external-deliverable handoff and acceptance record.
Five practical steps
- Read agreed criteria
- Log receipt and version without marking acceptance
- Identify the technical receiver and contract owner
- Record gaps for their review
- Track their acceptance decisions and the approved late-handoff route
Primary deliverable: External-deliverable handoff and acceptance record.
09Coordinate Clinical Study Dependencies
Practise how to track clinical milestones and records without making clinical decisions and produce a usable clinical operations dependency tracker.
Five practical steps
- Identify the clinical owner
- Read approved status sources
- Compare versions
- Flag discrepancy
- Coordinate the handoff; keep clinical judgment with qualified staff
Primary deliverable: Clinical operations dependency tracker.
10Connect CMC, Quality and Regulatory Inputs
Practise how to map specialist evidence and decision dates across functions and produce a usable specialist evidence-and-escalation map.
Five practical steps
- Map each required input
- Locate versioned evidence
- Mark pending judgments
- Ask specialists for dates
- Document escalation and receiving owner
Primary deliverable: Specialist evidence-and-escalation map.
11Prepare a Regulatory Meeting Handoff
Practise how to assemble a question and evidence package for qualified regulatory review and produce a usable regulatory meeting question-and-evidence handoff package.
Five practical steps
- Confirm applicable pathway with regulatory lead
- Collect versioned evidence
- Draft bounded questions
- Surface unknowns
- Obtain specialist review; route approval
Primary deliverable: Regulatory meeting question-and-evidence handoff package.
12Respond to a Quality or CMC Event
Practise how to record a quality or CMC event, preserve the source record, follow the locally authorized urgent route and produce a usable quality-and-CMC event response record.
Five practical steps
- Record the event time and controlled source version
- Follow the local urgent reporting route
- Contact quality and CMC owners and record time, receiver and acknowledgement
- Perform only an immediate action expressly permitted by procedure or directed by an owner
- Track specialist disposition as pending
Primary deliverable: Quality-and-cmc event response record.
Shape Product and Commercial Decisions
A promising scientific idea becomes a viable offering only when its requirements, evidence and intended users are clear. This module connects product requirements to a feasible sequence of work and tested commercial assumptions. You will compare options, coordinate a launch handoff and check the meaning of commercial metrics. Each recommendation should show its source, uncertainty and the owner who must approve the next decision.
13Write Evidence-Linked Product Requirements
Practise how to translate a documented user or scientific need into testable requirements and produce a usable evidence-linked product requirement brief.
Five practical steps
- Define user problem
- Locate evidence
- Express testable requirement
- Identify validation owner
- Flag claim status; revise after review
Primary deliverable: Evidence-linked product requirement brief.
14Prioritize the Product Roadmap
Practise how to compare feasible options against evidence maturity and dependencies and produce a usable product option and roadmap decision record.
Five practical steps
- List feasible options
- Agree criteria
- Compare evidence and dependencies
- Recommend sequence
- Record authorized choice and next review
Primary deliverable: Product option and roadmap decision record.
15Compare Market and Portfolio Scenarios
Practise how to assess market and competitor evidence without turning signals into forecasts and produce a usable market-and-portfolio scenario table.
Five practical steps
- Define decision
- Select comparable evidence
- Build scenarios
- Test sensitive assumptions
- State what new evidence would change recommendation
Primary deliverable: Market-and-portfolio scenario table.
16Coordinate Commercial Launch Readiness
Practise how to coordinate cleared research-tool claims, customer procurement and onboarding capacity, and produce a usable commercial launch-and-account handoff plan.
Five practical steps
- Confirm the research tool's intended use
- Map approved product and performance claims
- Ask commercial, scientific or medical, and legal owners to clear relevant claims
- Check onboarding capacity and customer procurement inputs
- Assign gap owners before launch commitments
Primary deliverable: Commercial launch-and-account handoff plan.
17Check the Commercial Metrics
Practise how to audit definitions, denominators, source periods and exceptions and produce a usable commercial metric definition and exception sheet.
Five practical steps
- Define metric before reading chart
- Inspect source and period
- Recalculate
- Test missingness
- State justified conclusion
Primary deliverable: Commercial metric definition and exception sheet.
Evaluate Partners, Finance and Strategic Choices
Biotech managers frequently bring together scientific, commercial, financial and legal inputs for a decision they do not make alone. This module teaches how to investigate a partner, frame options and show the effect of uncertain assumptions. You will practise a negotiation within delegated limits, present a decision request and close the loop after approval. Clear records and handoffs help the next owner act without mistaking a recommendation for authorization.
18Screen a Potential Partner
Practise how to structure scientific, capacity, IP and commercial diligence questions and produce a usable partner diligence question-and-evidence matrix.
Five practical steps
- Define fit hypothesis
- Request evidence by domain
- Assess provenance
- Protect confidential information
- Route legal and IP questions
Primary deliverable: Partner diligence question-and-evidence matrix.
19Frame a Transaction Option
Practise how to present interests, tradeoffs and approval limits for a potential alliance and produce a usable transaction option and approval-boundary brief.
Five practical steps
- Clarify the counterparty's interest
- Ask one focused question
- Summarize the requested concession without offering it
- Test it against delegated limits
- Record the exchange and approval owner; seek alliance and counsel review before communicating terms
Primary deliverable: Transaction option and approval-boundary brief.
20Test Financing and Runway Scenarios
Practise how to connect milestone timing, cash assumptions and downside ranges and produce a usable financing and runway scenario worksheet.
Five practical steps
- Check finance-owned inputs
- Model base and downside
- Vary timing
- Show sensitivity
- Ask finance to validate; prepare bounded discussion
Primary deliverable: Financing and runway scenario worksheet.
21Request an Executive Decision
Practise how to synthesize evidence, options, uncertainty and specialist input and produce a usable decision request and decision log.
Five practical steps
- State one decision
- Compare options
- Attach material evidence
- Expose uncertainty
- Identify approval owner; record actual outcome
Primary deliverable: Decision request and decision log.
22Implement an Approved Change
Practise how to rebaseline records and secure receiver acceptance and produce a usable approved rebaseline and closure record.
Five practical steps
- Verify approval
- Update controlled baseline
- Notify receivers
- Secure acceptance
- Close open actions and schedule review
Primary deliverable: Approved rebaseline and closure record.
Applied capstone
Help a sponsor choose the next step.
Use the relevant methods from the course to make a delayed biotech input visible as a bounded sponsor decision.
The situation
Engineering batch documentation may be about six weeks late. A partner slot and provisional clinical startup plan depend on the old handoff date, while Quality, CMC and Regulatory reviews remain open.
Your task
Compare keeping the current milestone plan with a controlled rebaseline. Recommend an immediate step, keep specialist judgments with their owners and propose confirmable handoff deadlines.
The people behind MTF
Meet MTF faculty and the learner community.
Explore the professional backgrounds of MTF faculty and learn more about the international community studying with the Institute.
Enrollment
Enroll in Professional Certificate in Biotech Management
One-time course price: €10, including applicable taxes. Payment is processed securely by Stripe. No card details are stored on the MTF Institute website.
You will receive an email with access to the course. If you have any difficulties, please write to welcome@gtf.pt.
Questions and details
Frequently asked questions
Open the sections that matter to you, including delivery format, AI-supported practice and the evidence used to design the curriculum.
Who is this biotech management course for?
It is designed for professionals who know basic biotechnology concepts and are beginning bounded cross-functional coordination. It is useful for aspiring biotech project managers and for product, business development and regulatory operations professionals who need to work across specialist teams.
How does the course work?
The course is online and self-paced. It contains 22 applied lessons across four modules, an applied capstone, and practical role-starter resources. Learners can work through it within one month at their own pace.
What will I produce?
You will practise 22 distinct workplace artifacts, including evidence and decision records, clinical and CMC handoffs, product and partner option briefs, a financing scenario worksheet and a final two-page sponsor decision brief.
How is AI used in the practical work?
Each lesson shows a drafting prompt, a separate critic prompt and the human checks needed before a document travels. AI can help structure a draft; qualified people retain scientific, clinical, quality, regulatory, legal, financial and sponsor decisions.
What evidence shaped the curriculum?
The course was built from an MTF Institute review of 102 current U.S. biotech management vacancy observations and a separate review of current industry changes. The vacancy report has an open Zenodo record and DOI.
Which career paths can this course inform?
The closest fit is biotech project coordination and management. Product, business development, strategy, regulatory and financing cases also help learners explore biotech product management, business development, strategy consulting, regulatory affairs, healthcare investment analysis and entrepreneurship alongside the specialist experience those paths require.
What certificate and access will I receive?
After enrollment, learners receive access to the MTF learning platform. Completing the course provides an MTF Institute course-completion certificate titled Professional Certificate in Biotech Management.